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Corona virus test kits

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Corona Virus Test Kits
The test is for professional use only

COVID-19 Test Kits are now available for the rapid determination of disease using a single drop of blood.
The test is a serologic test and looks for IgM (acute) and IgG (convalescent) antibodies to the virus.

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    COVID-19 IgG/IgM Rapid Test Kits 20/Pack

     

     

    Product Information:


    • Type: In Vitro Diagnostic Medical Device

    • Product Name: COVID-19 IgG/IgM Rapid Test
      Device


    Product Specs:

               o This test is an in vitro immunoassay for the direct and qualitative detection of anti-SARS- CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasma.

              o The test is for professional use only.

              o Pending FDA EUA

    • Validation study: Completed in the U.S. 5/2020: Sensitivity 90%, Specificity 100% (n=66).

    Coronavirus covid-19 test-kits
     

    • FDA Owner Operator Number: 10040710

    • FDA  approval details, please see below.

    .

    • EN ISO 13485:2016 • Brazil RDC ANVISA n. 16/2013,RDC  ANVISA n. 23/2012, RDC ANVISA n. 67/2009

    • Canada Medical Devices Regulations – Part 1 – SOR 98/282

    • United States 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 – Subparts A to D

 

 

NATIONAL CANCER INSTITUTE (NCI) STUDY:

 

The COVID-19 IgG/IgM Rapid Test Device was tested on 2020-06-15 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National Cancer Institute (NCI). The test was validated against a panel of previously frozen samples consisting of 30 SARSCoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples. Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the COVID-19 IgG/IgM Rapid Test Device. The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples were selected at different antibody titers. 

All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the COVID-19 IgG/IgM Rapid Test Device. Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008). 

For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false positive rates was calculated per a score method described by Altman).


 
COVID-19 IgG/IgM Rapid Test Device
(Whole Blood / Serum / Plasma)

COVID-19 testing are now available for the rapid determination of disease using a single drop of blood. The test is a serologic test and looks for IgM (acute) and IgG (convalescent) antibodies to the virus.

What are the known results:
 

IgM Testing

74/79 PCR+ patients who were also symptomatic also had a positive rapid test for IgM (93.7% sensitivity)

225/227 PCR (-) patients had a negative rapid test (Specificity 99.1%)

IgG Testing

82/83 patients who had recovered from the disease were positive for IgG

(Sensitivity 98.8%)

224/227 PCR (-) patients had a negative rapid test (Specificity 98.7%)

What are the upsides:

Testing is straightforward and results are immediate (see below for instructions).
  o
15 minutes to run the test.

The test uses 10 microliters of blood
  o
A nasopharyngeal swab is NOT required to administer this test.
  o
All contents required are found in the individually packaged kit.

It can help HCPs make decisions on who to get back to work and who may need to get further confirmatory testing.

Multiple tests can be done days apart to help improve accuracy.

 

 

                                                                         

 

                                                                        July 6, 2020  

 

 

Frank Lou

Director

Azure Biotech Inc.

Representing: Assure Tech. (Hangzhou Co., Ltd)

5250 Gulfton St. #2C

Houston, TX 77081

 

 

Device: 

 

 

Assure COVID-19 IgG/IgM Rapid Test Device

Company: 

 

 

Assure Tech. (Hangzhou Co., Ltd)

Indication:

 

 

Qualitative detection and differentiation of IgM and IgG antibodies

to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.

Authorized Laboratories:       Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform moderate or high complexity tests.

 

 

Dear Mr. Lou:

 

This letter is in response to your[1] request that the Food and Drug Administration (FDA) issue an Emergency Use Authorization (EUA) for emergency use of your product,[2]  pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).  

 

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. 

Pursuant to Section 564 of the Act, and on the basis of such determination, the Secretary of

HHS then declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19 subject to the terms of any authorization issued under Section 564(a) of the Act.[3]

 

Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of your product, described in the Scope of Authorization of this letter (Section II), subject to the terms of this authorization.

 

I.  Criteria for Issuance of Authorization

 

I have concluded that the emergency use of your product meets the criteria for issuance of an authorization under Section 564(c) of the Act, because I have concluded that:

 

1.  The SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus;

 

2.  Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing recent or prior infection with SARSCoV-2 by identifying individuals with an adaptive immune response to the virus that causes COVID-19, and that the known and potential benefits of your product when used for such use, outweigh the known and potential risks of your product; and

 

3.  There is no adequate, approved, and available alternative to the emergency use of your product.[4]

 

II.  Scope of Authorization

 

I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited to the indication above.

 

Authorized Product Details

 

Your product is a qualitative test intended for the detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, or plasma (sodium EDTA) specimens. The product is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.

 

To use your product, the device cassette, specimen, buffer, and/or controls should be equilibrated to room temperature. Using the provided disposable pipette, serum and plasma (approximately 5 µL) or venous whole blood (1 drop) is transferred to the specimen well. Two drops of buffer are then added to the specimen well.  Wait for 15 minutes and read the test results. An IgM Positive Result occurs when a colored line appears at the IgM test region and the colored line in the control region changes from blue to red, indicating that IgM against SARS-CoV-2 is present. An IgG Positive Result occurs when a colored line appears at the IgG test region and the colored line in the control region changes from blue to red, indicating that IgG against SARS-CoV-2 is present. A Positive Result for IgM and IgG occurs when colored lines occur at both IgM and IgG test regions as well as a blue to red color change in the line at the control region. A Negative Result occurs when the colored line in the control region changes from blue to red but no colored line appears in the IgM and IgG test regions, indicating that IgM and IgG antibodies against SARS-CoV-2 were not detected. An Invalid Result occurs when the colored line in the control region remains completely or partially blue and the test should be repeated.

 

Your product requires the following internal control, that is processed along with the sample on the device cassette. The internal control listed below must generate expected results in order for a test to be considered valid, as outlined in the Instructions for Use:

 

        Internal Control – The control line should change from blue to red on each strip for every test and checks that flow of reagents is satisfactory.

 

Your product also includes external positive and negative controls, or other authorized controls, to be run as outlined in the Instructions for Use:

 

        Positive Control: Lyophilized anti-SARS-CoV-2 IgG and anti-SARS-CoV-2 IgM,  resuspended with one vial of negative serum as described in the Instructions for Use.

        Negative Control: Lyophilized negative human serum resuspended as described in Instructions for Use.

 

Your product also requires the use of additional authorized materials and authorized ancillary reagents that are not included with your product and are described in the Instructions for Use. 

 

The above described product is authorized to be accompanied with labeling entitled “Assure COVID-19 IgG/IgM Rapid Test Device” Instructions for Use (available at

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-useauthorizations-medical-devices/vitro-diagnostics-euas), and the following product-specific information pertaining to the emergency use, which is required to be made available to healthcare providers and recipients:

 

        Fact Sheet for Healthcare Providers:  Assure COVID-19 IgG/IgM Rapid Test Device

        Fact Sheet for Recipients:  Assure COVID-19 IgG/IgM Rapid Test Device

 

The above described product, when accompanied by the Instructions for Use (identified above) and the two Fact Sheets (collectively referenced as “authorized labeling”) is authorized to be distributed to and used by authorized laboratories under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law.

 

I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of your product, when used consistent with the Scope of Authorization of this letter (Section II), outweigh the known and potential risks of your product.

 

I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that your product may be effective in diagnosing recent or prior infection with SARS-CoV-2 by identifying individuals with an adaptive immune response to the virus that causes COVID-19, when used consistent with the Scope of Authorization of this letter (Section II), pursuant to Section 564(c)(2)(A) of the Act.  

 

FDA has reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, and concludes that your product (as described in the Scope of Authorization of this letter (Section II) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness.

 

The emergency use of your product under this EUA must be consistent with, and may not exceed, the terms of this letter, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section IV).  Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), your product is authorized for the indication above.

 

III.   Waiver of Certain Requirements

 

I am waiving the following requirements for your product during the duration of this EUA:

 

Current good manufacturing practice requirements, including the quality system requirements under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution of your product, but excluding Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I (Nonconforming Product, 21 CFR 820.90), and Subpart O (Statistical Techniques, 21 CFR 820.250).

 

IV.  Conditions of Authorization

 

Pursuant to Section 564(e) of the Act, I am establishing the following conditions on this authorization:

 

Assure Tech. (Hangzhou Co., Ltd) and Authorized Distributor(s)[5]

 

A.    Your product must comply with the following labeling requirements under FDA regulations:  the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions for use (21 U.S.C. 352(f)), (21 CFR 809.10(b)(5), (7), and (8)); appropriate limitations on the use of the device including information required under 21 CFR 809.10(a)(4); and any available information regarding performance of the device, including requirements under 21 CFR 809.10(b)(12).

 

B.    You and authorized distributor(s) will make your product available with the authorized labeling to authorized laboratories.  You may request changes to the authorized

labeling.  Such requests will be made in consultation with, and require concurrence of,

DMD/OHT7-OIR/OPEQ/CDRH.

 

C.    You and authorized distributor(s) will make available on your website(s) the Fact Sheet for Healthcare Providers and the Fact Sheet for Recipients.

 

D.    You and authorized distributor(s) will inform authorized laboratories and relevant public health authorities of this EUA, including the terms and conditions herein, and any updates made to your product and authorized labeling.

 

E.     Through a process of inventory control, you and authorized distributor(s) will maintain records of the authorized laboratories to which they distribute the test and number of tests they distribute. 

 

F.     You and authorized distributor(s) will collect information on the performance of your product.  You will report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the product of which you become aware.

 

G.    You and authorized distributor(s) are authorized to make available additional information relating to the emergency use of your product that is consistent with, and does not exceed, the terms of this letter of authorization.

 

H.    You and authorized distributor(s) will make available the control material or other authorized control materials for purchase at the same time as your product.

 

Assure Tech. (Hangzhou Co., Ltd) (You)

 

I.       You will notify FDA of any authorized distributor(s) of your product, including the name, address, and phone number of any authorized distributor(s).

 

J.      You will provide authorized distributor(s) with a copy of this EUA and communicate to authorized distributor(s) any subsequent amendments that might be made to this EUA and its authorized accompanying materials (e.g., Fact Sheets).

 

K.    You may request to make available additional  authorized labeling specific to an authorized  distributor.  Such additional labeling may use another name for the product, but otherwise must be consistent with the authorized labeling, and not exceed the terms of authorization of this letter.  Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

 

L.     You will comply with the following requirements under FDA regulations:  Subpart H (Acceptance Activities, 21 CFR 820.80 and 21 CFR 820.86), Subpart I (Nonconforming Product, CFR 820.90), and Subpart O (Statistical Techniques, 21 CFR 820.250).

 

M.   You may request changes to the Scope of Authorization (Section II in this letter) of your product.  Such requests will be made in consultation with DMD/OHT7OIR/OPEQ/CDRH, and require concurrence of, Office of Counterterrorism and

Emerging Threats (OCET)/Office of the Chief Scientist (OCS)/Office of the Commissioner (OC) and DMD/OHT7-OIR/OPEQ/CDRH.

 

N.    You may request the addition of other ancillary methods for use with your product.  Such requests will be made in consultation with, and require concurrence of, DMD/OHT7OIR/OPEQ/CDRH.

 

O.    You may request the addition of other specimen types for use with your product.  Such requests will be made in consultation with, and require concurrence of, DMD/OHT7OIR/OPEQ/CDRH.

 

P.     You may request the addition and/or substitution of control materials for use with your product.  Such requests will be made in consultation with, and require concurrence of,

DMD/OHT7-OIR/OPEQ/CDRH.

 

Q.    You may request substitution for or changes to the authorized materials used in the detection process of human antibodies against SARS-CoV-2. Such requests will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

 

R.    You will evaluate the performance and assess traceability[6] of your product with any FDA-recommended reference material(s) or established panel(s) of characterized clinical specimens.  After submission to FDA and DMD/OHT7-OIR/OPEQ/CDRH’s review of and concurrence with the data, you will update your labeling to reflect the additional testing.  Such labeling updates will be made in consultation with, and require concurrence of, DMD/OHT7-OIR/OPEQ/CDRH.

 

S.     You will track adverse events, including any occurrence of false results and report to FDA under 21 CFR Part 803.

 

T.     You must have lot release procedures and the lot release procedures, including the study design and statistical power, must assure that the tests released for distribution have the clinical and analytical performance claimed in the authorized labeling.

 

U.    If requested by FDA, you must submit lot release procedures to FDA within 48 hours of such request, including sampling protocols, testing protocols, and acceptance criteria, that you use to release lots of your product for distribution in the U.S. 

 

V.    If requested by FDA, you will periodically submit new lots for testing at NCI, or by another government agency designated by FDA, to confirm continued performance characteristics across lots.  In addition, FDA may request records regarding lot release data for tests to be distributed or already distributed.  If such lot release data are requested by FDA, you must provide it within 48 hours of the request.

 

W.   You will complete the agreed upon real-time stability study for your product. After submission to FDA and DMD/OHT7-OIR/OPEQ/CDRH’s review of and concurrence with the data, you will update your product labeling to reflect the additional testing. Such labeling updates will be made in consultation with, and require concurrence of,

DMD/OHT7- OIR/OPEQ/CDRH.

 

Authorized Laboratories  

 

X.    Authorized laboratories using your product will include with test result reports, all authorized Fact Sheets.  Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media.

 

Y.    Authorized laboratories will use your product as outlined in the authorized labeling.  Deviations from the authorized procedures, including the authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.

Z.     Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing. 

 

AA.                   Authorized laboratories using your product will have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.  

 

BB.                    Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-

Reporting@fda.hhs.gov) and you (via email: contact@direagent.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of your product of which they become aware.

 

CC.                    All laboratory personnel using your product must be appropriately trained in immunochromatographic techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use your product in accordance with the authorized labeling.  All laboratory personnel using the assay must also be trained in and be familiar with the interpretation of results of the product.

 

Assure Tech. (Hangzhou Co., Ltd) (You), Authorized Distributors and Authorized Laboratories

 

DD.          You, authorized distributors, and authorized laboratories using your product will ensure that any records associated with this EUA are maintained until otherwise notified by FDA.  Such records will be made available to FDA for inspection upon request.

 

Conditions Related to Advertising and Promotion

 

EE. All descriptive printed matter, including advertising and promotional materials, relating to the use of your product, shall be consistent with the authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.

 

FF. No descriptive printed matter, including advertising or promotional materials, relating to the use of your product, may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2.

 

GG.                   All descriptive printed matter, including advertising and promotional materials, relating to the use of your product, shall clearly and conspicuously state that:

 

       This test has not been FDA cleared or approved;

 

       This test has been authorized by FDA under an EUA for use by authorized laboratories;

 

       This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and

 

       This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.

 

The emergency use of your product as described in this letter of authorization must comply with the conditions and all other terms of this authorization. 

 

V.  Duration of Authorization

 

This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act.

 

 

Sincerely,

 

 

 

____________________________

 

RADM Denise M. Hinton

 

Chief Scientist

 

Food and Drug Administration

 

 

 

 


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