Test Kit  Tech.        ( for innter-office study use only, not for public....)    4-2020   compiled by: Vic  vic@testkit.bz    Purpose..... Fight out Coronavirus ASAP from the world in 2020.

** 荧光PCR检测 比 胶体金。。。是不是较准确,也比较贵?USA: AbbottMesa Bio        


新型冠状 (肺 炎) 病毒   检测
  “新 型冠状 (肺 炎) 病毒  :检测
1. 核酸检 测    只要“轻轻一抹”。用棉签 的拭子去擦拭扁桃体和咽隐窝附近的分泌物,也可以通过鼻腔取鼻咽后部的分泌物,
                         然后放到试管里面,再交给检验科去做相应的病毒核酸的检查。    中国医院
价 为270  - 60元,
                        
PCR拭子检测:  Nasal and Oral swab tests   鼻拭子和口腔拭子检测   nucloic acid

2. 抗体检测   (
血 清) 检 测 igG 和 igM 两项,  样本来源于血液(血清、血浆、全血均可),极大 程度上避免了核酸检测采样时呼吸道样本对医护人员暴露的风险。
                        
IgG/IgM Test Kit (Colloidal Gold)                                                                                                                 中 国医院价为, 100 -  30 元
                        
Serological AntiBody Tests 血清学抗体测试
     
3. CT 
检测   当冠状病毒感染者达到 重症期的时候,用CT检测肺部, 看到大片呈白色,这时候已经都太迟了( 医 学影像检查技术 )       

***在原有核酸检测和测序基础上,增加了血清学检测的诊断标准 (核酸检测 + 抗体检测)
即“血清新型冠状病毒   特异性IgM抗体 和  IgG抗体阳性 ”或“
     血清新型冠状病毒   特异性IgG抗体 由阴性转为阳性   或  恢复期较急性期4倍及以上升高”也可确诊

     其中,IgM抗体阳性是早期感染的辅助诊断依据。IgM抗体约在感染后5~7 天产生,维持时间短,消失快。IgM抗体阳性,可判断早期感染,有利于早发现、早治疗。
               IgG抗体阳性,表示已经曾感染过新冠病毒,已产生抗体。IgG抗体在感染后10~15 天产生,可在血液循环中保持较长时间存在。
               IgG抗体阳性就是已经产生抵抗力了。
<>可以说,IgM是近期感染的标志,而 IgG是既往感染的标志。
               通过检测IgM和IgG,不仅可以鉴别人体是否感染,还能判断出患者是近期感染还是 既往感染

**相对于核酸检测,IgM检测方法最大的优势在于:操作更为简单、快捷,也无需借助任何仪器设备,方便许多基层医疗机构使用,这对基层的筛查工作有非常 重要的意义。

<>***普通人要不要做核酸检测
如 果一个普通人没有呼吸道症状,没有发热,也没有流行病学史,我们建议没有必要去做核酸检测,特别是扎堆做新冠病毒核酸检测,
但是如果他有发热等呼吸道症状,或者有重点疫区流行病学史,可就近去医院的发热门诊去做核酸检测。


  胶 体金       http://i.dxy.cn/    

The Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) has been developed for the identification of SARS-CoV-2,
                                the virus that causes COVID-19.
The test uses low sample volume of whole blood, serum and plasma to deliver rapid results within 15 minutes in just three steps.
新型冠状病毒(2019 nCoV)IgG/IgM检测试剂盒(胶体金)已用于SARS- CoV-2的鉴定,引起COVID-19的病毒。              
该试验使用低样本量的 全 血、血清和血浆,在15分钟内通过三个步骤快速得出结果。


胶体金是一种常用的标记技术,是以胶体 金作为示踪标志物应用于抗原抗体的一种新型的免疫标记 技术,有其独特的优点。
近年已在各种生物学研究中广泛使用。在临床使用的免疫印迹技术几乎都使用其标记。同时在流式、电镜、免疫、分子生物学以至生物芯片中都可能例用到。

1971 年Faulk 和Taytor将胶体金引入免疫化学,此后免疫胶体金技术作为一种新的免疫学方法,在生物医学各领域得到了日益 广泛的应用。
目前在医学检验中的应用主要是免疫层析法( immunochromatogra-phy) 和 快速免疫金渗滤法(Dot-immuogold filtration assay DIGFA),
用于检测 HBsAg、HCG 和抗双链DNA抗体等,具有简单、快速、准确和无污染等优点。

一、免疫胶体金技术的基本原理

胶 体金是由氯金酸(HAuCl4)在还原剂如白磷、抗坏血酸、枸橼酸钠、鞣酸等作用下,可聚合成一定大小的金颗粒,并由于静电作用成为一种稳定的胶体状态,
形成带负电的疏水胶溶液,由于静电作用而成为稳定的胶体状态,故称胶体金。
胶体金在弱碱环境下带负电荷,可与蛋白质分子的正电荷基团形 成牢固的结合,由于这种结合是静电结合,所以不影响蛋白质的生物特性。

胶 体金除了与蛋白质结合以外,还可以与许多其它生物大分子结合,如SPA、PHA、ConA等。
根据胶体金的一些物理性状,如高电子密度、颗粒大小、形状及颜色反应,加上结合物的免疫和生物学特性,
因而使胶体金广泛地应用于免疫学、组织学、病理学和细胞生物学等领域。

胶 体金标记,实质上是蛋白质等高分子被吸附到胶体金颗粒表面的包被过程。
吸附机理可能是胶体金颗粒表面负电荷,与蛋白质的正电荷基团因静电吸附而形成牢固结合。
用还原法可以方便地从氯金酸制备各种不同粒径、也就是不同颜色的胶体金颗粒。
这种球形的粒子对蛋白质有很强的吸附功能,可以与葡萄球菌A蛋白、免疫球蛋白、毒素、糖蛋白、酶、抗生素、激素、牛血清白蛋白多肽缀合物等非共价结合,
因而在基础研究和临床实验中成为非常有用的工具。

免 疫金标记技术 (Immunogold labelling techique) 主要利用了金颗粒具有高电子密度的特性,在金标蛋白结合处,在显微镜下可见黑褐色颗粒
当这些标记物在相应的配体处大量聚集时,肉眼可见红色或粉红色斑点, 因而用于定性或半定量的快速免疫检测方法中,
这一反应也可以通过银颗粒的沉积被放大,称之为免疫金银染色。

二、常用的免疫胶体金检测技术

(1) 免疫胶体金光镜染色法

细 胞悬液涂片或组织切片,可用胶体金标记的抗体进行染色,也可在胶体金标记的基础上,以银显影液增强标记,
使被还原的银原子沉积于已标记的金颗粒表面,可明显增强胶体金标记的敏感性。

免 疫胶体金电镜染色法

可 用胶体金标记的抗体或抗抗体与负染病毒样本或组织超薄切片结合,然后进行负染。可用于病毒形态的观察和病毒检测。

(2) 斑点免疫金渗滤法

应 用微孔滤膜(如膜)作载体,先将抗原或抗体点于膜上,封闭后加待检样本,洗涤后用胶体金标记的抗体检测相应的抗原或抗体。

(3) 胶体金免疫层析法

将 特异性的抗原或抗体以条带状固定在膜上,胶体金标记试剂(抗体或单克隆抗体)吸附在结合垫上,当待检样本加到试纸条一端的样本垫上后,
通过毛细作用向前移动,溶解结合垫上的胶体金标记试剂后相互反应,再移动至固定的抗原或抗体的区域时,
待检物与金标试剂的结合物又与之发生特异性结合而被截留,聚集在检测带上,可通过肉眼观察到显色结果。该法现已发展成为诊断试纸条,使用十分方便。


 荧光PCR法      COVID-19:首款新冠状病毒检测试剂出现,科学原理名为荧光PCR法....鼻 咽拭纸、痰液
                    
.上海企业 (4): 之江生物, 上海,之江生物、伯杰医疗、捷诺生物, 辉睿生物

湖北武汉COVID-19<>肺炎肆虐,上海市科学技术委员会周五(1-24-2020)公布,由上海之江生物科技公
研发的2019   新 型冠状病毒核酸检测试剂盒,  RT-P CR Kit 
当天通过上海市医疗器械检测所检验,成为中国首款法定检验机构检定合格的新型冠状病毒检测产品;在获得国家药监局批文后,
被发往各地医院、疾控中心和出入境检验检疫局,用于测定疑似患者的样本中是否有新型冠状病毒,可望加快识别疑似病例。
                

   
市科委生物医药处负责人表示,目前全国共有7间企业研发的试剂盒进入国家药监局快速审批通道,
其中4间为上海企业,分别是之江生物、伯杰医疗、捷诺生物和辉睿生物;另之江生物总经理邵俊斌透 露,在新型冠状病毒基因序列公布后,
该公司已立即启动检测试剂盒研发。

此次研发出来的试剂盒的科学原理名为“荧光PCR(聚合酶链式反应)法”,是一种用于放大扩增特定DNA片段的分子生物学 技术,
能利用聚合酶链式反应将微量的DNA大幅扩增,从而检测出带有特定基 因片段的病毒。

邵俊斌指出,开发这种试剂盒的   难点在于找出病毒的  特异性基因,且要考虑到病毒容易变异的特点,才能确保试剂盒的灵敏度和特异性
对于疑似病例,医护人员只须以试剂对疑似病患的 鼻咽拭纸、痰液、肺泡灌洗液  3种样本进行检测,就能测定是否含新型冠状病毒。
  


Master Standard....Abbott   


Abbott: Coronavirus Molecular Test:

Purpose:
Molecular testing helps detect tghe presence of a SARS-CoV-2 or coronavirus infection.
Here's how it works.

1. An upper respirotory troct swab collects a mucus sample for testing.


2. The Sample is mixed with reagents, which break open the  virus and release its genetic material,
     the viral RNA.


3. The reagents recognize a unique section of the coronavirus genome,
     while ignoring other viruses even if they're similar strains

4. The virus genome is replicated from a few target molecules up  to a billion,
     making ghe virus more detectable

5. Abbot's molecular test provides results to the healthcare provider.


ABBOTT LAUNCHES NOVEL CORONAVIRUS TEST
Test will be used on our m2000 RealTime system available
 in hospitals and molecular labs in the U.S.


Phone: Please call 1-800-553-7042, Option 1
2) Fax: Please fax this form to 1-224-361-7138
3) E-MAIL: Please e-mail this form to:
    CUSTOMERSERVICE@ABBOTTMOLECULAR.COM



Mar 18 2020

Abbott has received emergency use authorization (EUA) from the FDA for its molecular test for the identification of SARS-CoV-2, the virus that causes COVID-19.

The company is deploying 150,000 laboratory tests immediately.
Tests already have been sent to hospital and academic medical center labs in 18 states including Illinois, California, New York, Massachusetts and Washington.
Abbott is scaling up production at its U.S. manufacturing location to reach capacity for one million tests per week by end of March.

The Abbott RealTime SARS-CoV-2 EUA test can be used on Abbott's molecular instrument, the m2000 RealTime system,
by authorized laboratories in the U.S.
These lab instruments, which test for a broad array of infectious diseases and are found in health systems across the U.S.,
 can now have access to a SARS-CoV-2 assay to help healthcare providers deal with the high demand for testing. 


























IMPORTANT  TEST INFORMATION    (copied from abbott.com at 4-2020)
The Abbott RealTime SARS-CoV-2 EUA has not been FDA cleared or approved.
It has been been authorized by FDA under an emergency use authorization for use by authorized laboratories.
The test has been  authorized only for the detection of nucloic acid from SARS-CoV2, not for any other viruses or pathogens,
and is only authorized for the duration of the declartion that circumstances exist justifying the authorization of emergency use of in vitro diagnonstic
test detection and/or  diagnosis of COVID-19 under  Section 564(b) (1) of the Act. 21 U.S.C. #360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.


Curbing the COVID-19 Outbreak in RealTime

The Abbott RealTime SARS-C0V-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories,
using real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and
diagnosis of SARS-CoV-2 virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria.

icon-pdf.png

Fact Sheet for Patients: Understanding Results from the Abbott RealTime SARS-C0V-2 EUA Assay Results

icon-pdf.png

Fact Sheet for Healthcare Providers: Interpreting Abbott RealTime SARS-CoV-2 EUA Assay Results

icon-pdf.pngAbbott RealTime SARS-CoV-2 Assay Package Insert

 VIEW ORDERING INFORMATION


Abbott RealTime SARS-CoV-2 assay provides a fully automated solution to help laboratories address the urgent need for automated,
high-volume patient testing during the Coronavirus (COVID-19) pandemic.

The assay is engineered with:

  • Dual target assay for RdRp and N-genes
  • Qualitative detection of nucleic acids from SARS-CoV-2
  • maxRatio data analysis removes operator subjectivity
<>The Abbott RealTime SARS-CoV-2 assay in combination with the RealTime m2000 system allow scalable,
automated process   for flexible testing volumns (24-96 samples) and up to 470 patient samples in 24 hours.    

Important Safety Information

 INTENDED USE

 The Abbott RealTime SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for

the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal swabs, self-collected at health care location or collected by a healthcare worker,
nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare worker, from patients suspected of COVID-19 by their health care provider.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasal, nasopharyngeal and oropharyngeal swabs during the acute phase of infection.
Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
Positive results do not rule out bacterial infection or co-infection with other viruses.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Abbott RealTime SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR
and in vitro diagnostic procedures. The Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

LIMITATIONS OF PROCEDURE

For use under an Emergency Use Authorization only.

  • This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
  • Use of the Abbott RealTime SARS-CoV-2 assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Abbott m2000 System.
  • Laboratories are required to report all positive results to the appropriate public health authorities.
  • The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
  • Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert).
  • Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
  • False-negative results may arise from degradation of the viral RNA during shipping/storage.
  • The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated.
  • As with any molecular test, mutations within the target regions of Abbott RealTime SARS-CoV-2 assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
  • Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to qualify technology differences. One hundred percent agreement between the results should not be expected due to aforementioned differences between technologies. Users should follow their own specific policies/procedures.
  • Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
  • Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors.
  • Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.

Rx Only

This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.

  1. The Abbott RealTime SARS-CoV-2 assay has not been FDA cleared or approved;
  2. This test has been authorized by FDA under an EUA for use by authorized laboratories;
  3. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  4. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

Ordering Info

Abbott RealTime SARS-CoV-2 Amplification Reagent Kit (IVD)
UNIT ORDER # GTIN
96 assay (4 x 24) 09N77-095 00884999049109
Abbott RealTime SARS-CoV-2 Control Kit (IVD)
UNIT ORDER # GTIN
8 positive, 8 negative 09N77-085 00884999049086
Abbott RealTime SARS-CoV-2 Application Specification (IVD)
UNIT ORDER # GTIN
1 CD-ROM 09N77-010 00884999049055
Abbott multi-Collect Specimen Collection Kit with pierceable caps (IVD)
UNIT ORDER # GTIN
10 boxes, 50 kits each 09K12-004 00884999031715

Below are links to CDC website on:

Important Safety Information

INTENDED USE 

The Abbott RealTime SARS-CoV-2 assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal swabs, self-collected at health care location or collected by a healthcare worker, nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare worker, from patients suspected of COVID-19 by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasal, nasopharyngeal and oropharyngeal swabs during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The Abbott RealTime SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Abbott RealTime SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

LIMITATIONS OF PROCEDURE

For use under an Emergency Use Authorization only.

  • This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
  • Use of the Abbott RealTime SARS-CoV-2 assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Abbott m2000 System.
  • Laboratories are required to report all positive results to the appropriate public health authorities.
  • The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
  • Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert).
  • Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
  • False-negative results may arise from degradation of the viral RNA during shipping/storage.
  • The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated.
  • As with any molecular test, mutations within the target regions of Abbott RealTime SARS-CoV-2 assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
  • Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to qualify technology differences. One hundred percent agreement between the results should not be expected due to aforementioned differences between technologies. Users should follow their own specific policies/procedures.
  • Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
  • Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors.
  • Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.

Rx Only

This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.

  1. The Abbott RealTime SARS-CoV-2 assay has not been FDA cleared or approved;
  2. This test has been authorized by FDA under an EUA for use by authorized laboratories;
  3. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  4. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of
  5.  in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

  1.  U.S. Code § 360bbb–3 - Authorization for medical ...

    2020-3-16 · Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency ...

    https://www.law.cornell.edu/uscode/text/21/360bbb-3
  2. Section 564 of the Federal Food, Drug, and Cosmetic Act ...

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21 U.S. Code § 360bbb–3.Authorization for medical products for use in emergencies
    https://www.law.cornell.edu/uscode/text/21/360bbb-3 



(a) In general
(1) Emergency uses

Notwithstanding any provision of this chapter and section 351 of the Public Health Service Act [42 U.S.C. 262], and subject to the provisions of this section, the Secretary may authorize the introduction into interstate commerce, during the effective period of a declaration under subsection (b), of a drug, device, or biological product intended for use in an actual or potential emergency (referred to in this section as an “emergency use”).

(2) Approval status of productAn authorization under paragraph (1) may authorize an emergency use of a product that—
(A)
is not approved, licensed, or cleared for commercial distribution under section 355, 360(k), 360b, or 360e of this title or section 351 of the Public Health Service Act [42 U.S.C. 262] or conditionally approved under section 360ccc of this title (referred to in this section as an “unapproved product”); or
(B)
is approved, conditionally approved under section 360ccc of this title, licensed, or cleared under such a provision, but which use is not under such provision an approved, conditionally approved under section 360ccc of this title, licensed, or cleared use of the product (referred to in this section as an “unapproved use of an approved product”).
(3) Relation to other uses

An emergency use authorized under paragraph (1) for a product is in addition to any other use that is authorized for the product under a section of this chapter or the Public Health Service Act [42 U.S.C. 201 et seq.] referred to in paragraph (2)(A).

(4) DefinitionsFor purposes of this section:
(A)
The term “biological product” has the meaning given such term in section 351 of the Public Health Service Act [42 U.S.C. 262].
(B)
The term “emergency use” has the meaning indicated for such term in paragraph (1).
(C)
The term “product” means a drug, device, or biological product.
(D)
The term “unapproved product” has the meaning indicated for such term in paragraph (2)(A).
(E)
The term “unapproved use of an approved product” has the meaning indicated for such term in paragraph (2)(B).
(b) Declaration of emergency or threat justifying emergency authorized use
(1) In generalThe Secretary may make a declaration that the circumstances exist justifying the authorization under this subsection for a product on the basis of—
(A)
a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents;
(B) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to United States military forces, including personnel operating under the authority of title 10 or title 50, of attack with—
(i)
a biological, chemical, radiological, or nuclear agent or agents; or
(ii)
an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to United States military forces;
(C)
a determination by the Secretary that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of United States citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or
(D)
the identification of a material threat pursuant to section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b] sufficient to affect national security or the health and security of United States citizens living abroad.
(2) Termination of declaration
(A) In generalA declaration under this subsection shall terminate upon the earlier of—
(i)
a determination by the Secretary, in consultation as appropriate with the Secretary of Homeland Security or the Secretary of Defense, that the circumstances described in paragraph (1) have ceased to exist; or
(ii)
a change in the approval status of the product such that the circumstances described in subsection (a)(2) have ceased to exist.
(B) Disposition of product

If an authorization under this section with respect to an unapproved product ceases to be effective as a result of a termination under subparagraph (A) of this paragraph, the Secretary shall consult with the manufacturer of such product with respect to the appropriate disposition of the product.

(3) Advance notice of terminationThe Secretary shall provide advance notice that a declaration under this subsection will be terminated. The period of advance notice shall be a period reasonably determined to provide—
(A)
in the case of an unapproved product, a sufficient period for disposition of the product, including the return of such product (except such quantities of product as are necessary to provide for continued use consistent with subsection (f)(2)) to the manufacturer (in the case of a manufacturer that chooses to have such product returned); and
(B)
in the case of an unapproved use of an approved product, a sufficient period for the disposition of any labeling, or any information under subsection (e)(2)(B)(ii), as the case may be, that was provided with respect to the emergency use involved.
(4) Publication

The Secretary shall promptly publish in the Federal Register each declaration, determination, and advance notice of termination under this subsection.

(5) Explanation by Secretary

If an authorization under this section with respect to an unapproved product or an unapproved use of an approved product has been in effect for more than 1 year, the Secretary shall provide in writing to the sponsor of such product an explanation of the scientific, regulatory, or other obstacles to approval, licensure, or clearance of such product or use, including specific actions to be taken by the Secretary and the sponsor to overcome such obstacles.

(6) Military emergencies

In the case of a determination described in paragraph (1)(B), the Secretary shall determine, within 45 calendar days of such determination, whether to make a declaration under paragraph (1), and, if appropriate, shall promptly make such a declaration.

(c) Criteria for issuance of authorizationThe Secretary may issue an authorization under this section with respect to the emergency use of a product only if, after consultation with the Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances described in subsection (b)(1)), the Secretary concludes—
(1)
that an agent referred to in a declaration under subsection (b) can cause a serious or life-threatening disease or condition;
(2) that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that—
(A) the product may be effective in diagnosing, treating, or preventing—
(i)
such disease or condition; or
(ii)
a serious or life-threatening disease or condition caused by a product authorized under this section, approved or cleared under this chapter, or licensed under section 351 of the Public Health Service Act [42 U.S.C. 262], for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and
(B)
the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under subsection (b)(1)(D), if applicable;
(3)
that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition;
(4)
in the case of a determination described in subsection (b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and
(5)
that such other criteria as the Secretary may by regulation prescribe are satisfied.
(d) Scope of authorizationAn authorization of a product under this section shall state—
(1)
each disease or condition that the product may be used to diagnose, prevent, or treat within the scope of the authorization;
(2)
the Secretary’s conclusions, made under subsection (c)(2)(B), that the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product; and
(3)
the Secretary’s conclusions, made under subsection (c), concerning the safety and potential effectiveness of the product in diagnosing, preventing, or treating such diseases or conditions, including, to the extent practicable given the circumstances of the emergency, an assessment of the available scientific evidence.
(e) Conditions of authorization
(1) Unapproved product
(A) Required conditionsWith respect to the emergency use of an unapproved product, the Secretary, to the extent practicable given the applicable circumstances described in subsection (b)(1), shall, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(i) Appropriate conditions designed to ensure that health care professionals administering the product are informed—
(I)
that the Secretary has authorized the emergency use of the product;
(II)
of the significant known and potential benefits and risks of the emergency use of the product, and of the extent to which such benefits and risks are unknown; and
(III)
of the alternatives to the product that are available, and of their benefits and risks.
(ii) Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(I)
that the Secretary has authorized the emergency use of the product;
(II)
of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III)
of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
(iii)
Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the product.
(iv)
For manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.
(B) Authority for additional conditionsWith respect to the emergency use of an unapproved product, the Secretary may, for a person who carries out any activity for which the authorization is issued, establish such conditions on an authorization under this section as the Secretary finds necessary or appropriate to protect the public health, including the following:
(i)
Appropriate conditions on which entities may distribute the product with respect to the emergency use of the product (including limitation to distribution by government entities), and on how distribution is to be performed.
(ii)
Appropriate conditions on who may administer the product with respect to the emergency use of the product, and on the categories of individuals to whom, and the circumstances under which, the product may be administered with respect to such use.
(iii)
Appropriate conditions with respect to collection and analysis of information concerning the safety and effectiveness of the product with respect to the use of such product during the period when the authorization is in effect and a reasonable time following such period.
(iv)
For persons other than manufacturers of the product, appropriate conditions concerning recordkeeping and reporting, including records access by the Secretary, with respect to the emergency use of the product.
(2) Unapproved useWith respect to the emergency use of a product that is an unapproved use of an approved product:
(A)
For a person who carries out any activity for which the authorization is issued, the Secretary shall, to the extent practicable given the applicable circumstances described in subsection (b)(1), establish conditions described in clauses (i) and (ii) of paragraph (1)(A), and may establish conditions described in clauses (iii) and (iv) of such paragraph or in paragraph (1)(B).
(B)
(i)
If the authorization under this section regarding the emergency use authorizes a change in the labeling of the product, but the manufacturer of the product chooses not to make such change, such authorization may not authorize distributors of the product or any other person to alter or obscure the labeling provided by the manufacturer, except as provided in section 360bbb–3a of this title with respect to authorized changes to the product expiration date.
(ii)
In the circumstances described in clause (i), for a person who does not manufacture the product and who chooses to act under this clause, an authorization under this section regarding the emergency use shall, to the extent practicable given the circumstances of the emergency, authorize such person to provide appropriate information with respect to such product in addition to the labeling provided by the manufacturer, subject to compliance with clause (i). While the authorization under this section is effective, such additional information shall not be considered labeling for purposes of section 352 of this title.
(C)
In establishing conditions under this paragraph with respect to the distribution and administration of the product for the unapproved use, the Secretary shall not impose conditions that would restrict distribution or administration of the product when distributed or administered for the approved use.
(3) Good manufacturing practice; prescriptionWith respect to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), the Secretary may waive or limit, to the extent appropriate given the applicable circumstances described in subsection (b)(1)—
(A)
requirements regarding current good manufacturing practice otherwise applicable to the manufacture, processing, packing, or holding of products subject to regulation under this chapter, including such requirements established under section 351 or 360j(f)(1) of this title, and including relevant conditions prescribed with respect to the product by an order under section 360j(f)(2) of this title;
(B)
requirements established under subsection (b) or (f) of section 353 of this title or under section 354 of this title; and
(C)
requirements established under section 360j(e) of this title.
(4) AdvertisingThe Secretary may establish conditions on advertisements and other promotional descriptive printed matter that relate to the emergency use of a product for which an authorization under this section is issued (whether an unapproved product or an unapproved use of an approved product), including, as appropriate—
(A)
with respect to drugs and biological products, requirements applicable to prescription drugs pursuant to section 352(n) of this title; or
(B)
with respect to devices, requirements applicable to restricted devices pursuant to section 352(r) of this title.
(f) Duration of authorization
(1) In general

Except as provided in paragraph (2), an authorization under this section shall be effective until the earlier of the termination of the declaration under subsection (b) or a revocation under subsection (g).

(2) Continued use after end of effective period

Notwithstanding the termination of the declaration under subsection (b) or a revocation under subsection (g), an authorization shall continue to be effective to provide for continued use of an unapproved product with respect to a patient to whom, or an animal to which, it was administered during the period described by paragraph (1), to the extent found necessary by such patient’s attending physician or by the veterinarian caring for such animal, as applicable.

(g) Review and revocation of authorization
(1) ReviewThe Secretary shall periodically review the circumstances and the appropriateness of an authorization under this section. As part of such review, the Secretary shall regularly review the progress made with respect to the approval, conditional approval under section 360ccc of this title, licensure, or clearance of—
(A)
an unapproved product for which an authorization was issued under this section; or
(B)
an unapproved use of an approved product for which an authorization was issued under this section.
(2) Revision and revocationThe Secretary may revise or revoke an authorization under this section if—
(A)
the circumstances described under subsection (b)(1) no longer exist;
(B)
the criteria under subsection (c) for issuance of such authorization are no longer met; or
(C)
other circumstances make such revision or revocation appropriate to protect the public health or safety.
(h) Publication; confidential information
(1) Publication

The Secretary shall promptly publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization under this section, and an explanation of the reasons therefor (which may include a summary of data or information that has been submitted to the Secretary in an application under section 355(i)[1] 360b(j), or 360j(g) of this title, even if such summary may indirectly reveal the existence of such application). The Secretary shall make any revisions to an authorization under this section available on the Internet Web site of the Food and Drug Administration.

(2) Confidential information

Nothing in this section alters or amends section 1905 of title 18 or section 552(b)(4) of title 5.

(i) Actions committed to agency discretion

Actions under the authority of this section by the Secretary, by the Secretary of Defense, or by the Secretary of Homeland Security are committed to agency discretion.

(j) Rules of constructionThe following applies with respect to this section:
(1)
Nothing in this section impairs the authority of the President as Commander in Chief of the Armed Forces of the United States under article II, section 2 of the United States Constitution.
(2)
Nothing in this section impairs the authority of the Secretary of Defense with respect to the Department of Defense, including the armed forces, under other provisions of Federal law.
(3)
Nothing in this section (including any exercise of authority by a manufacturer under subsection (e)(2)) impairs the authority of the United States to use or manage quantities of a product that are owned or controlled by the United States (including quantities in the stockpile maintained under section 319F–2 of the Public Health Service Act [42 U.S.C. 247d–6b]).
(4)
Nothing in this section shall be construed as authorizing a delay in the review or other consideration by the Secretary of any application or submission pending before the Food and Drug Administration for a product for which an authorization under this section is issued.
(k) Relation to other provisions

If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].

(l) Option to carry out authorized activities

Nothing in this section provides the Secretary any authority to require any person to carry out any activity that becomes lawful pursuant to an authorization under this section, and no person is required to inform the Secretary that the person will not be carrying out such activity, except that a manufacturer of a sole-source unapproved product authorized for emergency use shall report to the Secretary within a reasonable period of time after the issuance by the Secretary of such authorization if such manufacturer does not intend to carry out any activity under the authorization. This section only has legal effect on a person who carries out an activity for which an authorization under this section is issued. This section does not modify or affect activities carried out pursuant to other provisions of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262]. Nothing in this subsection may be construed as restricting the Secretary from imposing conditions on persons who carry out any activity pursuant to an authorization under this section.

(m) Categorization of laboratory tests associated with devices subject to authorization
(1) In generalIn issuing an authorization under this section with respect to a device, the Secretary may, subject to the provisions of this section, determine that a laboratory examination or procedure associated with such device shall be deemed, for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a], to be in a particular category of examinations and procedures (including the category described by subsection (d)(3) of such section) if, based on the totality of scientific evidence available to the Secretary—
(A)
such categorization would be beneficial to protecting the public health; and
(B)
the known and potential benefits of such categorization under the circumstances of the authorization outweigh the known and potential risks of the categorization.
(2) Conditions of determination

The Secretary may establish appropriate conditions on the performance of the examination or procedure pursuant to such determination.

(3) Effective period

A determination under this subsection shall be effective for purposes of section 353 of the Public Health Service Act [42 U.S.C. 263a] notwithstanding any other provision of that section during the effective period of the relevant declaration under subsection (b).


42 U.S. Code § 263a.Certification of laboratories
(a) “Laboratory” or “clinical laboratory” defined

As used in this section, the term “laboratory” or “clinical laboratory” means a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(b) Certificate requirement

No person may solicit or accept materials derived from the human body for laboratory examination or other procedure unless there is in effect for the laboratory a certificate issued by the Secretary under this section applicable to the category of examinations or procedures which includes such examination or procedure.

(c) Issuance and renewal of certificates
(1) In general

The Secretary may issue or renew a certificate for a laboratory only if the laboratory meets the requirements of subsection (d).

(2) Term

A certificate issued under this section shall be valid for a period of 2 years or such shorter period as the Secretary may establish.

(d) Requirements for certificates
(1) In generalA laboratory may be issued a certificate or have its certificate renewed if—
(A) the laboratory submits (or if the laboratory is accredited under subsection (e), the accreditation body which accredited the laboratory submits), an application—
(i)
in such form and manner as the Secretary shall prescribe,
(ii) that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory including—
(I)
the number and types of laboratory examinations and other procedures performed,
(II)
the methodologies for laboratory examinations and other procedures employed, and
(III)
the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(iii)
that contains such other information as the Secretary may require to determine compliance with this section, and
the laboratory agrees to provide to the Secretary (or if the laboratory is accredited, to the accreditation body which accredited it) a description of any change in the information submitted under clause (ii) not later than 6 months after the change was put into effect,
(B) the laboratory provides the Secretary—
(i)
with satisfactory assurances that the laboratory will be operated in accordance with standards issued by the Secretary under subsection (f), or
(ii)
with proof of accreditation under subsection (e),
(C)
the laboratory agrees to permit inspections by the Secretary under subsection (g),
(D)
the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may reasonably require, and
(E)
the laboratory agrees to treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4).
(2) Requirements for certificates of waiver
(A) In generalA laboratory which only performs laboratory examinations and procedures described in paragraph (3) shall be issued a certificate of waiver or have its certificate of waiver renewed if—
(i) the laboratory submits an application—
(I)
in such form and manner as the Secretary shall prescribe,
(II)
that describes the characteristics of the laboratory examinations and other procedures performed by the laboratory, including the number and types of laboratory examinations and other procedures performed, the methodologies for laboratory examinations and other procedures employed, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and other procedures, and
(III)
that contains such other information as the Secretary may reasonably require to determine compliance with this section, and
(ii)
the laboratory agrees to make records available and submit reports to the Secretary as the Secretary may require.
(B) Changes

If a laboratory makes changes in the examinations and other procedures performed by it only with respect to examinations and procedures which are described in paragraph (3), the laboratory shall report such changes to the Secretary not later than 6 months after the change has been put into effect. If a laboratory proposes to make changes in the examinations and procedures performed by it such that the laboratory will perform an examination or procedure not described in paragraph (3), the laboratory shall report such change to the Secretary before the change takes effect.

(C) Effect

Subsections (f) and (g) shall not apply to a laboratory to which has been issued a certificate of waiver.

(3) Examinations and proceduresThe examinations and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that—
(A)
employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or
(B)
the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.
(4) “Certificate” defined

As used in this section, the term “certificate” includes a certificate of waiver issued under paragraph (2).

(e) Accreditation
(1) In generalA laboratory may be accredited for purposes of obtaining a certificate if the laboratory—
(A)
meets the standards of an approved accreditation body, and
(B)
authorizes the accreditation body to submit to the Secretary (or such State agency as the Secretary may designate) such records or other information as the Secretary may require.
(2) Approval of accreditation bodies
(A) In generalThe Secretary may approve a private nonprofit organization to be an accreditation body for the accreditation of laboratories if—
(i)
using inspectors qualified to evaluate the methodologies used by the laboratories in performing laboratory examinations and other procedures, the accreditation body agrees to inspect a laboratory for purposes of accreditation with such frequency as determined by [1] Secretary,
(ii)
the standards applied by the body in determining whether or not to accredit a laboratory are equal to or more stringent than the standards issued by the Secretary under subsection (f),
(iii)
there is adequate provision for assuring that the standards of the accreditation body continue to be met by the laboratory,
(iv)
in the case of any laboratory accredited by the body which has had its accreditation denied, suspended, withdrawn, or revoked or which has had any other action taken against it by the accrediting body, the accrediting body agrees to submit to the Secretary the name of such laboratory within 30 days of the action taken,
(v)
the accreditation body agrees to notify the Secretary at least 30 days before it changes its standards, and
(vi)
if the accreditation body has its approval withdrawn by the Secretary, the body agrees to notify each laboratory accredited by the body of the withdrawal within 10 days of the withdrawal.
(B) Criteria and procedures

The Secretary shall promulgate criteria and procedures for approving an accreditation body and for withdrawing such approval if the Secretary determines that the accreditation body does not meet the requirements of subparagraph (A).

(C) Effect of withdrawal of approvalIf the Secretary withdraws the approval of an accreditation body under subparagraph (B), the certificate of any laboratory accredited by the body shall continue in effect for 60 days after the laboratory receives notification of the withdrawal of the approval, except that the Secretary may extend such period for a laboratory if it determines that the laboratory submitted an application for accreditation or a certificate in a timely manner after receipt of the notification of the withdrawal of approval. If an accreditation body withdraws or revokes the accreditation of a laboratory, the certificate of the laboratory shall continue in effect—
(i)
for 45 days after the laboratory receives notice of the withdrawal or revocation of the accreditation, or
(ii)
until the effective date of any action taken by the Secretary under subsection (i).
(D) EvaluationsThe Secretary shall evaluate annually the performance of each approved accreditation body by—
(i)
inspecting under subsection (g) a sufficient number of the laboratories accredited by such body to allow a reasonable estimate of the performance of such body, and
(ii)
such other means as the Secretary determines appropriate.
(3) Omitted
(f) Standards
(1) In generalThe Secretary shall issue standards to assure consistent performance by laboratories issued a certificate under this section of valid and reliable laboratory examinations and other procedures. Such standards shall require each laboratory issued a certificate under this section—
(A)
to maintain a quality assurance and quality control program adequate and appropriate for the validity and reliability of the laboratory examinations and other procedures of the laboratory and to meet requirements relating to the proper collection, transportation, and storage of specimens and the reporting of results,
(B)
to maintain records, equipment, and facilities necessary for the proper and effective operation of the laboratory,
(C)
in performing and carrying out its laboratory examinations and other procedures, to use only personnel meeting such qualifications as the Secretary may establish for the direction, supervision, and performance of examinations and procedures within the laboratory, which qualifications shall take into consideration competency, training, experience, job performance, and education and which qualifications shall, as appropriate, be different on the basis of the type of examinations and procedures being performed by the laboratory and the risks and consequences of erroneous results associated with such examinations and procedures,
(D)
to qualify under a proficiency testing program meeting the standards established by the Secretary under paragraph (3), and
(E)
to meet such other requirements as the Secretary determines necessary to assure consistent performance by such laboratories of accurate and reliable laboratory examinations and procedures.
(2) ConsiderationsIn developing the standards to be issued under paragraph (1), the Secretary shall, within the flexibility provided under subparagraphs (A) through (E) of paragraph (1), take into consideration—
(A)
the examinations and procedures performed and the methodologies employed,
(B)
the degree of independent judgment involved,
(C)
the amount of interpretation involved,
(D)
the difficulty of the calculations involved,
(E)
the calibration and quality control requirements of the instruments used,
(F)
the type of training required to operate the instruments used in the methodology, and
(G)
such other factors as the Secretary considers relevant.
(3) Proficiency testing program
(A) In general

The Secretary shall establish standards for the proficiency testing programs for laboratories issued a certificate under this section which are conducted by the Secretary, conducted by an organization approved under subparagraph (C), or conducted by an approved accrediting body. The standards shall require that a laboratory issued a certificate under this section be tested for each examination and procedure conducted within a category of examinations or procedures for which it has received a certificate, except for examinations and procedures for which the Secretary has determined that a proficiency test cannot reasonably be developed. The testing shall be conducted on a quarterly basis, except where the Secretary determines for technical and scientific reasons that a particular examination or procedure may be tested less frequently (but not less often than twice per year).

(B) Criteria

The standards established under subparagraph (A) shall include uniform criteria for acceptable performance under a proficiency testing program, based on the available technology and the clinical relevance of the laboratory examination or other procedure subject to such program. The criteria shall be established for all examinations and procedures and shall be uniform for each examination and procedure. The standards shall also include a system for grading proficiency testing performance to determine whether a laboratory has performed acceptably for a particular quarter and acceptably for a particular examination or procedure or category of examination or procedure over a period of successive quarters.

(C) Approved proficiency testing programs

For the purpose of administering proficiency testing programs which meet the standards established under subparagraph (A), the Secretary shall approve a proficiency testing program offered by a private nonprofit organization or a State if the program meets the standards established under subparagraph (A) and the organization or State provides technical assistance to laboratories seeking to qualify under the program. The Secretary shall evaluate each program approved under this subparagraph annually to determine if the program continues to meet the standards established under subparagraph (A) and shall withdraw the approval of any program that no longer meets such standards.

(D) Onsite testing

The Secretary shall perform, or shall direct a program approved under subparagraph (C) to perform, onsite proficiency testing to assure compliance with the requirements of subsection (d)(5). The Secretary shall perform, on an onsite or other basis, proficiency testing to evaluate the performance of a proficiency testing program approved under subparagraph (C) and to assure quality performance by a laboratory.

(E) Training, technical assistance, and enhanced proficiency testingThe Secretary may, in lieu of or in addition to actions authorized under subsection (h), (i), or (j), require any laboratory which fails to perform acceptably on an individual examination and procedure or a category of examination and procedures—
(i)
to undertake training and to obtain the necessary technical assistance to meet the requirements of the proficency [2] testing program,
(ii)
to enroll in a program of enhanced proficiency testing, or
(iii)
to undertake any combination of the training, technical assistance, or testing described in clauses (i) and (ii).
(F) Testing results

The Secretary shall establish a system to make the results of the proficiency testing programs subject to the standards established by the Secretary under subparagraph (A) available, on a reasonable basis, upon request of any person. The Secretary shall include with results made available under this subparagraph such explanatory information as may be appropriate to assist in the interpretation of such results.

(4) National standards for quality assurance in cytology services
(A) Establishment

The Secretary shall establish national standards for quality assurance in cytology services designed to assure consistent performance by laboratories of valid and reliable cytological services.

(B) StandardsThe standards established under subparagraph (A) shall include—
(i)
the maximum number of cytology slides that any individual may screen in a 24-hour period,
(ii)
requirements that a clinical laboratory maintain a record of (I) the number of cytology slides screened during each 24-hour period by each individual who examines cytology slides for the laboratory, and (II) the number of hours devoted during each 24-hour period to screening cytology slides by such individual,
(iii)
criteria for requiring rescreening of cytological preparations, such as (I) random rescreening of cytology specimens determined to be in the benign category, (II) focused rescreening of such preparations in high risk groups, and (III) for each abnormal cytological result, rescreening of all prior cytological specimens for the patient, if available,
(iv)
periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions,
(v)
procedures for detecting inadequately prepared slides, for assuring that no cytological diagnosis is rendered on such slides, and for notifying referring physicians of such slides,
(vi)
requirements that all cytological screening be done on the premises of a laboratory that is certified under this section,
(vii)
requirements for the retention of cytology slides by laboratories for such periods of time as the Secretary considers appropriate, and
(viii)
standards requiring periodic inspection of cytology services by persons capable of evaluating the quality of cytology services.
(g) Inspections
(1) In general

The Secretary may, on an announced or unannounced basis, enter and inspect, during regular hours of operation, laboratories which have been issued a certificate under this section. In conducting such inspections the Secretary shall have access to all facilities, equipment, materials, records, and information that the Secretary determines have a bearing on whether the laboratory is being operated in accordance with this section. As part of such an inspection the Secretary may copy any such material or require to it [3] be submitted to the Secretary. An inspection under this paragraph may be made only upon presenting identification to the owner, operator, or agent in charge of the laboratory being inspected.

(2) Compliance with requirements and standards

The Secretary shall conduct inspections of laboratories under paragraph (1) to determine their compliance with the requirements of subsection (d) and the standards issued under subsection (f). Inspections of laboratories not accredited under subsection (e) shall be conducted on a biennial basis or with such other frequency as the Secretary determines to be necessary to assure compliance with such requirements and standards. Inspections of laboratories accredited under subsection (e) shall be conducted on such basis as the Secretary determines is necessary to assure compliance with such requirements and standards.

(h) Intermediate sanctions
(1) In general

If the Secretary determines that a laboratory which has been issued a certificate under this section no longer substantially meets the requirements for the issuance of a certificate, the Secretary may impose intermediate sanctions in lieu of the actions authorized by subsection (i).

(2) Types of sanctionsThe intermediate sanctions which may be imposed under paragraph (1) shall consist of—
(A)
directed plans of correction,
(B)
civil money penalties in an amount not to exceed $10,000 for each violation listed in subsection (i)(1) or for each day of substantial noncompliance with the requirements of this section,
(C)
payment for the costs of onsite monitoring, or
(D)
any combination of the actions described in subparagraphs (A), (B), and (C).
(3) Procedures

The Secretary shall develop and implement procedures with respect to when and how each of the intermediate sanctions is to be imposed under paragraph (1). Such procedures shall provide for notice to the laboratory and a reasonable opportunity to respond to the proposed sanction and appropriate procedures for appealing determinations relating to the imposition of intermediate sanctions [4]

(i) Suspension, revocation, and limitation
(1) In generalExcept as provided in paragraph (2), the certificate of a laboratory issued under this section may be suspended, revoked, or limited if the Secretary finds, after reasonable notice and opportunity for hearing to the owner or operator of the laboratory, that such owner or operator or any employee of the laboratory—
(A)
has been guilty of misrepresentation in obtaining the certificate,
(B)
has performed or represented the laboratory as entitled to perform a laboratory examination or other procedure which is not within a category of laboratory examinations or other procedures authorized in the certificate,
(C)
has failed to comply with the requirements of subsection (d) or the standards prescribed by the Secretary under subsection (f),
(D) has failed to comply with reasonable requests of the Secretary for—
(i)
any information or materials, or
(ii)
work on materials,
that the Secretary concludes is necessary to determine the laboratory’s continued eligibility for its certificate or continued compliance with the Secretary’s standards under subsection (f),
(E)
has refused a reasonable request of the Secretary, or any Federal officer or employee duly designated by the Secretary, for permission to inspect the laboratory and its operations and pertinent records during the hours the laboratory is in operation,
(F)
has violated or aided and abetted in the violation of any provisions of this section or of any regulation promulgated thereunder, or
(G)
has not complied with an intermediate sanction imposed under subsection (h).
(2) Action before a hearingIf the Secretary determines that—
(A)
the failure of a laboratory to comply with the standards of the Secretary under subsection (f) presents an imminent and serious risk to human health, or
(B)
a laboratory has engaged in an action described in subparagraph (D) or (E) of paragraph (1),
the Secretary may suspend or limit the certificate of the laboratory before holding a hearing under paragraph (1) regarding such failure or refusal. The opportunity for a hearing shall be provided no later than 60 days from the effective date of the suspension or limitation. A suspension or limitation under this paragraph shall stay in effect until the decision of the Secretary made after the hearing under paragraph (1).
(3) Ineligibility to own or operate laboratories after revocation

No person who has owned or operated a laboratory which has had its certificate revoked may, within 2 years of the revocation of the certificate, own or operate a laboratory for which a certificate has been issued under this section, except that if the revocation occurs pursuant to paragraph (4) the Secretary may substitute intermediate sanctions under subsection (h) instead of the 2-year prohibition against ownership or operation which would otherwise apply under this paragraph. The certificate of a laboratory which has been excluded from participation under the medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] because of actions relating to the quality of the laboratory shall be suspended for the period the laboratory is so excluded.

(4) Improper referrals

Any laboratory that the Secretary determines intentionally refers its proficiency testing samples to another laboratory for analysis may have its certificate revoked for at least one year and shall be subject to appropriate fines and penalties as provided for in subsection (h).

(j) Injunctions

Whenever the Secretary has reason to believe that continuation of any activity by a laboratory would constitute a significant hazard to the public health the Secretary may bring suit in the district court of the United States for the district in which such laboratory is situated to enjoin continuation of such activity. Upon proper showing, a temporary injunction or restraining order against continuation of such activity pending issuance of a final order under this subsection shall be granted without bond by such court.

(k) Judicial review
(1) Petition

Any laboratory which has had an intermediate sanction imposed under subsection (h) or has had its certificate suspended, revoked, or limited under subsection (i) may, at any time within 60 days after the date the action of the Secretary under subsection (i) or (h) becomes final, file a petition with the United States court of appeals for the circuit wherein the laboratory has its principal place of business for judicial review of such action. As soon as practicable after receipt of the petition, the clerk of the court shall transmit a copy of the petition to the Secretary or other officer designated by the Secretary for that purpose. As soon as practicable after receipt of the copy, the Secretary shall file in the court the record on which the action of the Secretary is based, as provided in section 2112 of title 28.

(2) Additional evidence

If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal of such additional evidence) to be taken before the Secretary, and to be adduced upon the hearing in such manner and upon such terms and conditions as the court may deem proper. The Secretary may modify the findings of the Secretary as to the facts, or make new findings, by reason of the additional evidence so taken, and the Secretary shall file such modified or new findings, and the recommendations of the Secretary, if any, for the modification or setting aside of his original action, with the return of such additional evidence.

(3) Judgment of court

Upon the filing of the petition referred to in paragraph (1), the court shall have jurisdiction to affirm the action, or to set it aside in whole or in part, temporarily or permanently. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.

(4) Finality of judgment

The judgment of the court affirming or setting aside, in whole or in part, any such action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.

(l) Sanctions

Any person who intentionally violates any requirement of this section or any regulation promulgated thereunder shall be imprisoned for not more than one year or fined under title 18, or both, except that if the conviction is for a second or subsequent violation of such a requirement such person shall be imprisoned for not more than 3 years or fined in accordance with title 18, or both.

(m) Fees
(1) Certificate fees

The Secretary shall require payment of fees for the issuance and renewal of certificates, except that the Secretary shall only require a nominal fee for the issuance and renewal of certificates of waiver.

(2) Additional fees

The Secretary shall require the payment of fees for inspections of laboratories which are not accredited and for the cost of performing proficiency testing on laboratories which do not participate in proficiency testing programs approved under subsection (f)(3)(C).

(3) Criteria
(A) Fees under paragraph (1)

Fees imposed under paragraph (1) shall be sufficient to cover the general costs of administering this section, including evaluating and monitoring proficiency testing programs approved under subsection (f) and accrediting bodies and implementing and monitoring compliance with the requirements of this section.

(B) Fees under paragraph (2)

Fees imposed under paragraph (2) shall be sufficient to cover the cost of the Secretary in carrying out the inspections and proficiency testing described in paragraph (2).

(C) Fees imposed under paragraphs (1) and (2)

Fees imposed under paragraphs (1) and (2) shall vary by group or classification of laboratory, based on such considerations as the Secretary determines are relevant, which may include the dollar volume and scope of the testing being performed by the laboratories.

(n) InformationOn April 1, 1990 and annually thereafter, the Secretary shall compile and make available to physicians and the general public information, based on the previous calendar year, which the Secretary determines is useful in evaluating the performance of a laboratory, including—
(1)
a list of laboratories which have been convicted under Federal or State laws relating to fraud and abuse, false billings, or kickbacks,
(2) a list of laboratories—
(A)
which have had their certificates revoked, suspended, or limited under subsection (i), or
(B)
which have been the subject of a sanction under subsection (l),
together with a statement of the reasons for the revocation, suspension, limitation, or sanction,
(3)
a list of laboratories subject to intermediate sanctions under subsection (h) together with a statement of the reasons for the sanctions,
(4)
a list of laboratories whose accreditation has been withdrawn or revoked together with a statement of the reasons for the withdrawal or revocation,
(5)
a list of laboratories against which the Secretary has taken action under subsection (j) together with a statement of the reasons for such action, and
(6)
a list of laboratories which have been excluded from participation under title XVIII or XIX of the Social Security Act [42 U.S.C. 1395 et seq., 1396 et seq.].
The information to be compiled under paragraphs (1) through (6) shall be information for the calendar year preceding the date the information is to be made available to the public and shall be accompanied by such explanatory information as may be appropriate to assist in the interpretation of the information compiled under such paragraphs.
(o) Delegation

In carrying out this section, the Secretary may, pursuant to agreement, use the services or facilities of any Federal or State or local public agency or nonprofit private organization, and may pay therefor in advance or by way of reimbursement, and in such installments, as the Secretary may determine.

(p) State laws
(1)
Except as provided in paragraph (2), nothing in this section shall be construed as affecting the power of any State to enact and enforce laws relating to the matters covered by this section to the extent that such laws are not inconsistent with this section or with the regulations issued under this section.
(2)
If a State enacts laws relating to matters covered by this section which provide for requirements equal to or more stringent than the requirements of this section or than the regulations issued under this section, the Secretary may exempt clinical laboratories in that State from compliance with this section.
(q) Consultations

In carrying out this section, the Secretary shall consult with appropriate private organizations and public agencies.

(July 1, 1944, ch. 373, title III, § 353, as added Pub. L. 90–174, § 5(a), Dec. 5, 1967, 81 Stat. 536; amended Pub. L. 100–578, § 2, Oct. 31, 1988, 102 Stat. 2903; Pub. L. 105–115, title I, § 123(h), Nov. 21, 1997, 111 Stat. 2324; Pub. L. 112–202, § 2, Dec. 4, 2012, 126 Stat. 1483.)



 
https://www.mesabiotech.com/
company-leadership  products coronavirus  news-media   contact-us
SanDiego USA




Accula SARS-CoV-2 Test
Rapid point-of-care testing for the virus that causes COVID-19

Accula SARS-CoV-2 Test has received FDA Emergency Use Authorization

Mesa Biotech has developed a qualitative,

visually read test utilizing polymerase chain reaction (PCR) technology to

detect SARS-CoV-2, the virus responsible for COVID-19. 

Using throat and nasal swabs, 

results are available in 30 minutes, based on the principles of Mesa’s commercially

available Accula Influenza and RSV tests.

This system provides actionable, laboratory-quality results at the point of care.

The system allows for decentralized care for immediately actionable results.


Press Releases
Read More →




Our Company
Mesa Biotech designs, develops, manufactures and commercializes next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care.
Our patented system enables healthcare professionals to access actionable, laboratory-quality results at the point-of-care with greater sensitivity and specificity than current infectious disease rapid immunoassay tests.
Our Goal
We strive to bring DNA and RNA testing to a much larger population segment than alternative, legacy solutions so healthcare providers can more effectively treat patients.
Our Technology
Our proprietary OSCAR technology is key to our patented and patent-pending diagnostic solutions. Our revolutionary technology offers the simplicity, convenience and procedural familiarity of traditional POC rapid immunoassays while providing the superior sensitivity, specificity of laboratory-based molecular testing.


The key to our success is our team of
dedicated and talented employees,

employees that are driven to deliver
novel, quality diagnostic products.


Point-of-Care Molecular System      Accula SARS-CoV-2 Test



  COLLECT
Simple nasal swab specimen collection
LOAD & RUN
Dispense the buffer into the cassette, close the dock lid and walk away.
READ
When notified by the dock, remove the cassette and read the test results.


Mesa Biotech’s unique and patent-pending technology amplifies, labels and
provides a visual qualitative result in a low-cost, disposable cassette in 30 minutes or less.

Benefits of Mesa Biotech’s point-of-care molecular testing technology include:
Mesa Biotech’s unique test kits provide everything needed to conduct rapid molecular tests at the point-of-care.

The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere,
 from the physician’s office to the patient’s home.
In 30 minutes or less of collecting a sample, the user can obtain a laboratory-quality molecular test result and
take appropriate action.
Proprietary assay design allows for the rapid development of a portfolio of tests for human,
agricultural, food pathogens, or genetic disease targets.

The flexibility of Mesa Biotech’s hardware design allows for rapid, sensitive, specific,
multiplexed detection of disease targets in one easy-to-use device.

Mesa Biotech’s technology thus offers the simplicity, convenience and procedural familiarity of traditional POC
rapid immunoassays while providing the superior sensitivity,
specificity and information content of laboratory-based molecular testing.


Accula SARS-CoV-2 Test

FDA EUA Letter of Authorization

Instructions for Use (IFU)

Quick Reference Guide (QRG)

Health Care Provider Fact Sheet

Patient Fact Sheet

Accula Dock Operator’s Guide
The Accula SARS-CoV-2 Test has not been FDA cleared or approved; it has been authorized by FDA
under an EUA for use by authorized laboratories. 
This test has been authorized only for the detection of nucleic acid from SARS-CoV-2,
not for any other viruses or pathogens.
 The Accula SARS-CoV-2 Test is only authorized for the duration of the declaration that circumstances exist justifying
 the authorization of emergency
use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19
under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1),
 unless the authorization is terminated or revoked sooner.

Mesa’s products are distributed in the USA & Canada
 by Sekisui Diagnostics under the Silaris brand.     Sekisui Diagnostics                 www.sekisuidiagnostics.com                      questions@sekisui-dx.com
** Technical Support
For US product questions, additional training needs, product complaints or potential adverse events, please contact Sekisui Diagnostics at (800) 332-1042 or SDADiagnosticsTSDL@sekisui-dx.com
For other product questions, product complaints or potential adverse events, contact Mesa Biotech at info@mesabiotech.com



Easy Work Flow Like Conventional Lateral Flow Tests

Combining molecular PCR accuracy
         with a traditional visually read result
   *
 
    *      PCR
    *      Cost Effective
    *      Easy to Use
    *      Room Temperature Storage
    *      Small Footprint
    *      CE Mark
    *      CLIA Waived


Products

The next generation in diagnostic testing is here. The Accula™ System is a sample-to-answer nucleic acid PCR amplification platform solution for the point-of-care (POC) with the simplicity, convenience and procedural familiarity of traditional rapid immunoassays. This patented system provides actionable, laboratory-quality results at POC with greater sensitivity and specificity than current infectious disease rapid immunoassay tests. The Accula Flu A/Flu B and the Accula RSV tests have obtained CE Mark in the EU and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA).

The system is comprised of a palm-sized dock with single-use cassettes.


Products in the Works

Products which are being developed or under clinical trials.

  • Instrument with connectivity

  • Accula Strep A

  • Accula CT/NG/TV

  • Accula HSV 1+2/VZV


  Genrui Biotech Inc.

Genrui Biotech Inc.

specializes in developing,
manufacturing and marketing IVD equipment and reagents.

The company’s product range covers immunoassay,
chemistry, hematology, urinalysis, and point-of-care,

 as well as associated reagents.

info source from... https://www.trademed.com  



Artificial Intelligence System Diagnoses Coronavirus (COVID-19) in Seconds

by Reading CT Images  By Medimaging International staff writers     11 Mar 2020       





























A new smart image-reading system has been launched by Ping An Insurance (Group) Company of China, Ltd. (Shenzhen, China)
that can assist doctors with efficient and accurate diagnoses by leveraging artificial intelligence (AI) and
could help control the epidemic through earlier diagnoses and treatment.


As COVID-19 is a new disease, medical institutions,
especially at the primary level in China, lack diagnosis experience.

The Nucleic Acid Test (NAT) had been regarded as the major reference for COVID-19 diagnoses.
However, as the epidemic continues to spread, the NAT has had several problems,
including long detection times and a high proportion of false negative cases.
This has resulted in some patients missing the chance for early treatment or quarantine.
 Many doctors have used Computed Tomography (CT) images for diagnosis,
although there is a lack of radiologists in the epidemic areas for reviewing the volume of CT imaging.


The COVID-19 smart image-reading system has been trained using used clinical data and aims to close this gap.
The AI analysis engine can conduct a comparative analysis of multiple CT scan images of the same patient and measure the changes in lesions.
It helps doctors to track the development of the disease, evaluate the treatment and arrive at the prognosis for the patients.
It assists doctors in diagnosing, triaging and evaluating COVID-19 patients swiftly and effectively.
The COVID-19 smart image-reading system also supports AI image-reading remotely by medical professionals outside the epidemic areas.


Medical institutions that require COVID-19 smart image-reading services can also gain access on public or private cloud platforms or on premises. At the same time, the public or private cloud platforms support storing and sharing electronic film. The smart image-reading system can also be quickly transplanted to CT equipment with the help of manufacturers to assist in diagnosing the COVID-19.

"Patients with COVID-19 need multiple CT scans during the treatment. Comparing multiple images is a time-consuming task and it cannot be accurately completed manually. Utilizing Ping An Smart Healthcare's COVID-19 smart image-reading system, it can effectively improve the diagnostic accuracy and the doctor's image-reading efficiency," said Dr. Xiao Jing, Chief Scientist of Ping An.

Related Links:     Image: Ping An Smart Healthcare’s smart image-reading system
                                     (Photo courtesy of Ping An Insurance (Group) Company of China, Ltd.)
Ping An Insurance (Group) Company of China, Ltd.

**Sources

 https://www.trademed.com/products/9022/Coronavirus-Test.html