covid-19 igg/igm rapid test
TRANSCRIPT
Healgen Scientific LLC001-713-733-8088www.healgen.com
COVID-19 IgG/IgM Rapid Test
COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid
phase immunochromatographic assay for the rapid, qualitative and differential
detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole
blood, serum or plasma.
Key Facts of COVID-19
Features & Benefits
Test Procedure & Interpretation
Ordering Information
The 2019 new coronavirus pneumonia(NCP), or"COVID-19", was discovered for the 2019 Wuhan Viral Pneumonia case in China and was named by the world Health Organization on January 12, 2020.
For confirmed coronavirus disease 2019 (COVID-19) cases, reported illnesses have ranged from mild symptoms to severe illness and death. Symptoms can include:
• Fever• Cough• Shortness of breath
• Between people who are in close contact with one another (within about 6 feet).• Via respiratory droplets produced when an infected person coughs or sneezes.• These droplets can land in the mouths or noses of people who are nearby or possibly
be inhaled into the lungs.
• Fast results as soon as 2-10 minutes• Facilitates patient treatment decisions quickly• Simple, time-saving procedure• Little specimens, only 5 µL of serum/plasma or 10 µL of whole blood specimens• All necessary reagents provided & no equipment needed• High sensitivity and specificity
The virus is thought to spread mainly from person-to-person.
10 min
2 drops of buffer
OR
1 drop of whole blood
Specimen Line
IgM IgG IgG&IgM
CGM
CGM
CGM
CGM
CGM
CGM
CGM
CGM
ID
B
S CGM
ID
B
S CGM
ID
B
S CGM
Buf
fer
Product Description
COVID-19 IgG/IgM Rapid Test
Specimen
Whole Blood/Serum/Plasma
Format
Cassette
Catalog No.
GCCOV-402a
Kit Size
25 Tests/Kit
5 μL of serum/plasma
FDA / EUA AUTHORIZED
1
Cat: GCCOV-402a
For Emergency Authorization Use (EUA) only For in vitro diagnostic use only For prescription use only
INTENDED USE
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) 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. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, to perform moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. IgM and IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
The sensitivity of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) early after infection in unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG or IgM assay.
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only for use under the Food and Drug Administration’s Emergency Use Authorization.
INTRODUCTION
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals, and birds and that cause respiratory, enteric, hepatic, and neurologic diseases. Seven coronavirus species are known to cause human disease. Four viruses - 229E, OC43, NL63, and HKU1 - are prevalent and typically cause common cold symptoms in immunocompetent individuals.4 The three other strains - severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) - are zoonotic in origin and have been linked to sometimes fatal illness. IgG and IgM antibodies to 2019 Novel Coronavirus can be detected with 1-3 weeks after exposure. The seroconversion rate and the antibody levels increased rapidly during the first two weeks.
PRINCIPLE
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunochromatographic assay. The test uses anti-human IgM antibody (test line IgM) , anti-human IgG (test line IgG) and rabbit IgG (control line C) immobilized on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens (SARS-CoV-2 Spike S1 antigen) conjugated with colloid gold (COVID-19 conjugates). When a specimen
followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID-19 conjugates making an antigen antibodies complex. This complex migrates through nitrocellulose membrane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-human IgM &/or anti-human IgG) the complex is trapped forming a burgundy colored band which confirms a reactive test result. Absence of a colored band in the test region indicates a non-reactive test result.
To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
MATERIALS SUPPLIED
25 sealed pouches each containing a test cassette, a dropper and a desiccant 1 Buffer 1 Package insert
MATERIAL REQUIRED BUT NOT PROVIDED
1. Specimen collection containers 2. Centrifuge (for plasma only) 3. Timer
STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
WARNINGS AND PRECAUTIONS
1. For professional in vitro diagnostic use only. Do not use after expiration date.
2. Use of this product is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.
3. This test should be performed at 15 to 30℃. If stored refrigerated, ensure that the pouch and buffer are brought to operating temperature before performing testing.
4. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
5. Do not use it if the tube/pouch is damaged or broken.
6. Test is for single use only. Do not re-use under any circumstances.
7. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
8. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
9. Humidity and temperature can adversely affect results (especially with an RH over 80%). Testing must be performed within one hour after opening the pouch .
10. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.
11. Practice a few times the use of the mini dropper prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by pipette capable to deliver 5 μL of volume.
COVID-19 IgG/IgM Rapid Test Cassette
(Whole Blood/Serum/Plasma)
Instruction for Use
In Vitro Diagnostic Medical Device
2
12. This test has not been FDA cleared or approved.
13. This test has been authorized by FDA under an EUA for use by authorized laboratories.
14. 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.
15. 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.
SPECIMEN COLLECTION
1. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) can be performed using either venous whole blood, serum or plasma.
2. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) test has not been evaluated with fingerstick specimens. Use of this test with fingerstick blood is not recommended.
3. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
4. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C for up to one month. Whole blood specimens must be stored at 2-8˚C if not tested immediately and tested within 24 hours of collection. Do not freeze whole blood specimens.
5. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens cannot be frozen and thawed more than 3 times.
6. If specimens are to be shipped, they should be packed in compliance with local regulations covering the transportation of etiologic agents.
TEST PROCEDURE
Allow test cassette, specimen, buffer and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Results must be obtained within one hour.
2. Place the test device on a clean and level surface.
For Serum or Plasma Specimens:
With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
Note: Practice a few times prior to testing if you are not familiar with the mini dropper. For better precision, transfer specimen by pipette capable to deliver 5 μL of volume.
For Venous Whole Blood Specimen:
Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well (S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.
3. Wait for the colored line(s) to appear. After 2 minutes, if the red color has not moved across the test window or if blood is still present in the specimen well (S), add 1 additional drop of the sample buffer to the buffer well (B).
4. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
NEGATIVE:
The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.
IgM POSITIVE:
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.
IgG POSITIVE:
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies
IgG and IgM POSITIVE:
The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.
INVALID:
Control line is partially red, and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
QUALITY CONTROL
A procedural control is included in the test. A red line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. Additional controls may be required according to guidelines or local, state, and/or federal regulations (such as 42 CFR 493.1256) or accrediting organizations.
LIMITATIONS
For use under an Emergency Use Authorization only.
1. Use of COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is limited to laboratory personnel who have been trained. Not for home use.
2. This product is only used for testing of individual serum, plasma (Li+ heparin, K2EDTA and sodium citrate), and venous whole blood. Other specimen types have not been evaluated and should not be used with this assay.
3. Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that can block the membrane. This slows the flow of reagents and can lead to high background color, making the interpretation of results difficult.
4. The Assay Procedure and the Interpretation of Assay Result must be followed closely when testing for the presence of SARS-CoV-2 virus specific antibodies in the serum, plasma or whole blood specimen from individual subjects. For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results.
5. Reading test results earlier than 10 minutes after the addition of Buffer may yield erroneous results. Do not interpret the result after 15 minutes.
6. This test detects the presence of SARS-CoV-2 IgM/IgG in the specimen and should not be used to diagnose or exclude SARS-CoV-2 infection. Testing with
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a molecular diagnostic must be performed to evaluate for active infection in symptomatic individuals.
7. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to re-infection.
8. A positive result may not indicate previous SARS-CoV-2 infection. Consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an adaptive immune response.
9. A negative result for an individual subject indicates absence of detectable anti-SARS-CoV-2 antibodies. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. IgM antibodies may not be detected in the first few days of infection; the sensitivity of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) early after infection is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a diagnostic determination is made. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.
10. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
11. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is limited to the qualitative detection of antibodies specific for the SARS-CoV-2 virus. The intensity of the test line does not necessarily correlate to SARS-CoV-2 antibody titer in the specimen. Neither the quantitative value nor the rate anti- SARS-CoV-2 IgM/IgG concentration can be determined by this qualitative test.
12. The sensitivity of the test is impacted after being open for two hours—the density of T line becomes weak. Testing must be performed within one hour after opening the pouch.
CONDITIONS OF AUTHORIZATION FOR THE
LABORATORY
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.
Authorized laboratories using the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) (“your product” in the conditions below), must adhere to the Conditions of Authorization indicated in the Letter of Authorization as listed below:
1. Authorized laboratories* using your product will include with result reports of your product, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may be used, which may include mass media
2. Authorized laboratories using your product will use your product as outlined in the Instructions for Use. 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.
3. Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing.
4. 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.
5. Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/ CDRH (via email: [email protected]) and Healgen Scientific LLC ([email protected]) any suspected occurrence of false reactive or false non-reactive results and significant deviations from the established performance characteristics of your product of which they become aware.
6. All laboratory personnel using your product must be appropriately trained in immunoassay 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
7. 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.
*The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests” as “authorized laboratories.”
PERFORMANCE CHARACTERISTICS
1. Assay Clinical Performance
Study 1: Healgen Clinical Agreement Validation
The clinical performance of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) was evaluated by testing a total of 191 plasma (K2EDTA) clinical samples—90 positive samples and 101 negative samples) from individual patients exhibiting pneumonia, respiratory symptoms and fever etc. Testing was performed at two sites in China from January to mid-March 2020. COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) results for IgM and IgG detection were compared to the results of RT-PCR assays for SARS-CoV-2 from oropharyngeal swabs (Site #1) and sputum (Site #2). At Site #1, 61 retrospective specimens and 4 prospective specimens were included in the study. At Site #2, 95 retrospective specimens and 31 prospective specimens were included in the study. The time from RT-PCR result to collection of specimens (plasma) ranged from 15-45 days (Site #1) and 0-38 days (Site #2). The time from collection of specimens (plasma) from each individual to testing ranged from 12-23 days (Site #1) and 3-29 days (Site #2). Overall study results are shown in below (Table 1).
Table 1: Assay Clinical Study Results
Method RT-PCR
Subtotal Positive Negative
COVID-19 IgG/IgM
Rapid Test Cassette
Positive
IgG+/IgM+ 78 0 78
IgG-/IgM+ 0 1 1
IgG+/IgM- 9 2 11
Negative IgG-/IgM- 3 98 101
Subtotal 90 101 191 IgG
Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%～98.9%) Negative Percent agreement (NPA): 98.0% (99/101) (95%CI: 93.1%~99.5%)
IgM
Positive Percent agreement (PPA): 86.7% (78/90) (95%CI: 78.1%~92.2%) Negative Percent agreement (NPA): 99.0% (100/101) (95%CI: 94.6%~99.8%)
Overall (either IgG+ or IgM+)
Positive Percent agreement (PPA): 96.7% (87/90) (95%CI: 90.7%～98.9%) Negative Percent agreement (NPA): 97.0% (98/101) (95%CI: 91.6%～99.0%)
Study 2: Independent Clinical Agreement Validation
The test was validated against a panel of previously frozen samples consisting of 30 SARS-CoV-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 Cassette (Whole Blood/Serum/Plasma). 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 Cassette (Whole Blood/Serum/Plasma). 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). The results and data analysis are shown in the tables below.
Table 2. Summary Results Comparator Method
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COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma)
Positive (IgM/IgG) +
Negative (IgM/IgG)-
Negative, HIV+ Total
Positive
IgM +/ IgG+ 29 0 0 29
IgM+, IgG- 1 0 0 1
IgM-, IgG+ 0 2 0 2
Negative IgM- / IgG)- 0 68 10 78
Total (n=110) 30 70 10 110
Table 3. Summary Statistics
Measure Estimate Confidence Interval
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
(IgM+ or IgG+; Total) Sensitivity (PPA) 100% (30/30) (88.7%; 100%)
(IgM-/IgG-; Total) Specificity (NPA) 97.5% (78/80) (91.3%; 99.3%)
Cross-reactivity with HIV+ 0% (0/10)
not detected
Limitations of Study 2
• Samples were not randomly selected, and sensitivity and specificity estimates may not be indicative of the real-world performance of the device.
• These results are based on serum and plasma samples only and may not be indicative of performance with other sample types, such as whole blood, including finger stick blood.
• Information about anticoagulants used is not known.
• The number of samples in the panel is a minimally viable sample size that still provides reasonable estimates and confidence intervals for test performance, and the samples used may not be representative of the antibody profile observed in patient populations.
2. Assay Cross Reactivity
Cross-reactivity of the COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma) was evaluated using serum samples which contain antibodies to the pathogens listed below. A total of 120 specimens from 24 different categories were tested. No false Positives were found with the following (Table 4): Table 4: Assay Cross Reactivity Results
Sample Categories Tested Sample Number Influenza A virus IgG 5 Influenza B virus IgG 5 Respiratory syncytial virus IgG 5 Adenovirus IgG 5 Rhinovirus IgG 5 Human metapneumovirus IgG 5 Mycoplasma pneumoniae IgG 5 Chlamydia pneumoniae IgG 5 HCV IgG 5 Haemophilus influenza IgG 5 HBV core antibody IgG 5 Bacterial pneumonia 5 Influenza A virus IgM 5 Influenza B virus IgM 5 Respiratory syncytial virus IgM 5 Adenovirus IgM 5 Rhinovirus IgM 5 Human metapneumovirus IgM 5 Mycoplasma pneumoniae IgM 5 Chlamydia pneumoniae IgM 5 HCV IgM 5
Haemophilus influenza IgM 5 HBV core antibody IgM 5 Antinuclear antibodies (ANA) 5
3. Potentially Endogenous Interfering Substances
Low titer COVID-19 antibody positive serum samples and COVID-19 antibody negative serum samples were spiked with one of the following substances to specified concentrations and tested in multiple replicates. No false Positives or false Negatives were found with the following (Table 5).
Table 5: Assay Interfering Substance Results
Name of Substances Concentration Ascorbic Acid 20 mg/dL Hemoglobin 1000 mg/dL Bilirubin 10 mg/dL Albumin 2000 mg/dL Triglyceride 500 mg/dL
4. Class Specificity
A Class Specificity Study was conducted to determine the impact of DTT treatment on the detection of IgM and/or IgG positive samples by the COVID-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma). IgM samples treated with DTT showed no visible IgM line with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), whereas the IgG samples were not affected by DTT treatment. Test results with IgM positive samples after DTT treatment showed 100% agreement to the expected results. Test results with IgG positive samples after DTT treatment showed 100% agreement to the expected results. The results observed confirm the class specificity of the test.
5. Study of: Venous Whole Blood and Plasma Specimens with
Anticoagulants
To evaluate if various anticoagulants have an effect on the results of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma), negative plasma specimens and positive plasma specimens (with 2 different low positive IgG and IgM concentrations) were mixed with three different anticoagulants (lithium heparin, EDTA, sodium citrate) in separate tubes and tested in triplicate in plasma only or spiked into venous whole blood. IgG and IgM were correctly identified in all spiked whole blood specimens by the test, similar to results obtained with the plasma only specimens. There was a 100% concordance rate with expected results when IgM or IgG positive venous whole blood specimens or plasma specimens were tested with anticoagulants.
REFERENCE:
1. Weiss SR, Leibowitz JL. Coronavirus pathogenesis. Adv Virus Res 2011; 81: 85-164.
2. Masters PS, Perlman S. Coronaviridae. In: Knipe DM, Howley PM, eds. Fields virology. 6th ed. Lippincott Williams & Wilkins, 2013: 825-58.
3. Su S, Wong G, Shi W, et al. Epidemiology, genetic recombination, and pathogenesis of coronaviruses. Trends Microbiol 2016; 24: 490-502.
4. Cui J, Li F, Shi ZL. Origin and evolution of pathogenic coronaviruses. Nat Rev Microbiol 2019; 17: 181-192.
Manufactured for:
Healgen Scientific LLC Address: 3818 Fuqua Street,
Houston, TX 77047, USA. Tel: +1 713-733-8088 Fax: +1 713-733-8848 Website: www.healgen.com
Revision Date: 2020-5-2
May 29, 2020
Jinjie Hu, Ph.D. Axteria BioMed Consulting Inc. Representing: Healgen Scientific LLC 8040 Cobble Creek Circle Potomac, MD 20854
Device: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Company: Healgen Scientific LLC Indication: Qualitative detection and differentiation of IgM and IgG antibodies
against SARS-CoV-2 in human venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum. 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, to perform moderate or high complexity tests.
Dear Dr. Hu:
This letter is in response to your1 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
1 For ease of reference, this letter will use the term “you” and related terms to refer to Healgen Scientific LLC 2 For ease of reference, this letter will use the term “your product” to refer to the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) for the indication identified above.
Page 2 – Jinjie Hu, Healgen Scientific LLC
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 SARS-CoV-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 for the detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in venous whole blood, plasma (Li+-heparin, K2-EDTA and sodium-citrate), and serum. 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, and sample buffer are allowed to equilibrate to room temperature. Serum and plasma (5 µL) or one drop of venous whole blood (10 µL) is transferred to the specimen well. Then 2 drops of sample buffer are added to the buffer well. Wait for 10 minutes and read the test results. Results are not to be read after 15 minutes. An IgM Positive Result occurs when a colored line appears at the M Test Line (M) region and the colored 3 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. 85 FR 7316 (February 7, 2020). 4 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act.
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line changes from blue to red in the Control Line (C); this indicates that IgM against SARS-CoV-2 is present. An IgG Positive Result occurs when a colored line appears at the G Test Line (G) region and the colored line changes from blue to red in the Control Line (C); this indicates that IgG against SARS-CoV-2 is present. A positive result for IgM and IgG occurs when colored lines occur at both M and G as well as the change in color at C. A Negative Result occurs when the change in color occurs at C only and indicates that IgM and IgG antibodies against SARS-CoV-2 were not detected. An Invalid Result occurs when the line at C remains completely or partially blue and fails to completely change to red; the test should then be repeated.
Your product requires the following internal control, that is processed along with the specimen 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 C line color change from blue to red should appear for every test and checks that flow of reagents is satisfactory.
You also recommend use of external positive and negative controls, or other authorized controls, to be run as outlined in the 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 “COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Instructions for Use” (available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations), 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: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
· Fact Sheet for Recipients: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
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 authorized product, when used to diagnose recent or prior infection with SARS-CoV-2 by identifying individuals with an adaptive immune response to the virus and used consistently 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 consistently with the
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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:
Healgen Scientific LLC (You) 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 5 “Authorized Distributor(s)” are identified by you, Healgen Scientific LLC, in your EUA submission as an entity allowed to distribute your device.
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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 your SARS-CoV-2 IgM and IgG Positive Control(s) and a Negative Control by June 26, 2020, and, when available, refer to condition T.
Healgen Scientific LLC (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: acceptance activities (21 CFR 820.80 and 21 CFR 820.86), nonconforming product (21 CFR 820.90), and 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/OHT7-OIR/OPEQ/CDRH, and require concurrence of, Office of Counterterrorism and
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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/OHT7-OIR/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/OHT7-OIR/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 traceability6 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 recommend use of external positive and negative controls, to be run as outlined in the Instructions for Use. You will develop SARS-CoV-2 IgM and IgG Positive Control(s) and a Negative Control and submit data demonstrating reactivity levels sufficient to serve as proper control for the performance of your product. After submission to FDA and DMD/OHT7-OIR/OPEQ/CDRH’s review of and concurrence, you will update your labeling with the information on these external controls by June 26, 2020.
U. 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.
V. Within 48 hours following authorization, you must submit lot release procedures to FDA, including sampling protocols, testing protocols, and acceptance criteria, that you use to release lots of your product for distribution in the US.
6 Traceability refers to tracing analytical sensitivity/reactivity back to an FDA-recommended reference material.
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W. If requested by FDA, manufacturers will periodically submit new lots for testing at the National Cancer Institute (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.
X. 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
Y. 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.
Z. Authorized laboratories will use your product as outlined in the Instructions for Use. 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.
AA. Authorized laboratories that receive your product will notify the relevant public health authorities of their intent to run your product prior to initiating testing.
BB. 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.
CC. Authorized laboratories will collect information on the performance of your product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]) and you ([email protected]) 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.
DD. All laboratory personnel using your product must be appropriately trained in immunoassay 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.
Healgen Scientific LLC (You), Authorized Distributors and Authorized Laboratories
EE. You, authorized distributors, and authorized laboratories using your product will
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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 Printed Materials, Advertising and Promotion
FF. All descriptive printed matter, including advertising and promotional materials, relating to the use of your product shall be consistent with authorized labeling, as well as the terms set forth in this EUA and the applicable requirements set forth in the Act and FDA regulations.
GG. 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.
HH. 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.
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Sincerely,
____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration
Enclosures
Coronavirus Disease 2019 (COVID-19)
FACT SHEET FOR HEALTHCARE PROVIDERS Healgen Scientific LLC, COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
May 29, 2020
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is authorized for the detection of IgG and IgM antibodies against SARS-CoV-2 in human serum, plasma (EDTA, lithium heparin, and sodium citrate), or venous whole blood.
This test detects human SARS-CoV-2 IgM and IgG that are generated as part of the human adaptive immune response to the COVID-19 virus and is to be performed only using human serum, plasma, or venipuncture whole blood specimens.
All individuals whose specimens are tested with one of these tests will receive the Fact Sheet for Recipients: COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma).
What are the symptoms of COVID-19? Many individuals with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, fever, difficulty breathing). The current information available to characterize the spectrum of clinical illness associated with COVID-19 suggests that symptoms include cough, shortness of breath or dyspnea, fever, chills, myalgias, headache, sore throat or new loss of taste or smell. Based on what is known about the virus that causes COVID-19, signs and symptoms may appear any time from 2 to 14 days after exposure to the virus. Based on preliminary data, the median incubation period is approximately 5 days, but may range 2-14 days.
Public health officials have identified cases of COVID-19 infection throughout the world, including the United States, which poses risks to public health. Please check the CDC webpage for the most up-to-date information.
What do I need to know about COVID-19 antibody testing? Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section). • COVID-19 IgG/IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) can be ordered by healthcare providers to test human venous
whole blood, plasma, or serum to detect if there has been an adaptive immune response to COVID-19, indicating recent or prior infection.
• COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) should not be used to diagnose or exclude acute infection and should not be used as the sole basis for treatment or patient management decisions. Direct testing for SARS-CoV-2 should be performed if acute infection is suspected.
• COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is only authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.
Specimens should be collected with appropriate infection control precautions. Current guidance for COVID-19 infection control precautions are available at the CDC’s website (see links provided in “Where can I go for updates and more information” section).
Use appropriate personal protective equipment when collecting and handling specimens from individuals suspected of having COVID-19 as outlined in the CDC Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19). For additional information, refer to CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19) (see links provided in “Where can I go for updates and more information” section).
Coronavirus Disease 2019 (COVID-19)
FACT SHEET FOR HEALTHCARE PROVIDERS Healgen Scientific LLC, COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
May 29, 2020
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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There are no approved available alternative tests. FDA has issued EUAs for other antibody tests that can be found at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov.
What does it mean if the specimen tests positive for antibodies against the virus that causes COVID-19? A positive test result with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to SARS-CoV-2. Antibodies to SARS-CoV-2 are generally detectable several days following infection. Individuals may have detectable virus present for several weeks following seroconversion. A positive result can indicate recent or past infection but does not exclude recently infected patients who are still contagious. It is unknown how long antibodies to SARS-CoV-2 will remain present in the body after infection and if they confer immunity to infection. Incorrect assumptions of immunity may lead to premature discontinuation of physical distancing requirements and increase the risk of infection for individuals, their households and the public. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) has been designed to minimize the likelihood of false positive test results. However, in the event of a false positive result, risks to individuals could include the following: a recommendation for isolation of the individual, monitoring of household or other close contacts for symptoms, isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 individuals, limits in the ability to work, the delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects. Due to the risk of false positive results, confirmation of positive results should be considered – using a second,
different antibody assay that detects the same type of antibodies. Laboratory test results should always be considered in the context of clinical observations and epidemiological data in making patient management decisions. All laboratories using this test must follow standard confirmatory testing and reporting guidelines according to their appropriate public health authorities. What does it mean if the specimen tests negative for antibodies against virus that causes COVID-19? A negative test result with this test means that SARS-CoV-2 specific antibodies were not present in the specimen above the limit of detection. However, patients tested early after infection may not have detectable antibodies despite active infection; in addition, it is not certain that all infected patients will develop a detectable antibody response to SARS-CoV-2 infection. A negative result should not be used to rule out infection. Direct testing of SARS-CoV-2 should be performed if acute infection is suspected. The absolute sensitivity of the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is unknown. Risks to an individual resulting from a false negative result include: restriction of activities deemed acceptable for individuals with evidence of an antibody response to SARS-CoV-2, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events. What is an EUA? The United States (U.S.) FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
An IVD made available under an EUA has not undergone the same type of review as an FDA-approved or cleared IVD. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate,
Coronavirus Disease 2019 (COVID-19)
FACT SHEET FOR HEALTHCARE PROVIDERS Healgen Scientific LLC, COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
May 29, 2020
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
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approved, available alternatives, and based on the totality of scientific evidence available, it is reasonable to believe that this IVD may be effective. The EUA for the test you received is in effect for the duration of the COVID-19 declaration justifying emergency use of IVDs, unless terminated or revoked (after which the test may no longer be used).
Where can I go for updates and more information?
CDC webpages: General: https://www.cdc.gov/COVID19 Healthcare Professionals: https://www.cdc.gov/coronavirus/2019-nCoV/guidance-hcp.html Information for Laboratories: https://www.cdc.gov/coronavirus/2019- nCoV/guidance-laboratories.html Laboratory Biosafety: https://www.cdc.gov/coronavirus/2019- nCoV/lab-biosafety-guidelines.html Isolation Precautions in Healthcare Settings: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control- recommendations.html Specimen Collection: https://www.cdc.gov/coronavirus/2019- nCoV/guidelines-clinical-specimens.html Infection Control: https://www.cdc.gov/coronavirus/2019- ncov/infection-control/index.html
FDA webpages: General: www.fda.gov/novelcoronavirus EUAs: (includes links to recipient fact sheet and manufacturer’s instructions) https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Manufacturer Contact Information: Healgen Scientific LLC 3818 Fuqua Street Houston, TX 77047 USA
Contact email: [email protected] Website: www.healgen.com