Independent Evaluations of COVID-19 Serological Tests

Serology tests detect the presence of antibodies in the blood when the body is responding to a specific infection, like COVID-19. In other words, the tests detect the body’s immune response to the infection caused by the virus rather than detecting the virus itself. In the early days of an infection when the body’s immune response is still building, antibodies may not be detected. This limits the test’s effectiveness for diagnosing COVID-19, and this is one reason serology tests should not be used as the sole basis to diagnose COVID-19. Serology tests could play a role in the fight against COVID-19 by helping healthcare professionals identify individuals who may have developed an immune response to SARS-CoV-2. In addition, these test results can aid in determining who may donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. However, to use serology tests properly, it is important to understand their performance characteristics and limitations. Moreover, studies are underway to address questions that will better inform the appropriate use of these tests, such as whether the presence of antibodies conveys a level of immunity that would prevent or reduce the severity of re-infection as well as the duration for which immunity lasts.

Key Facts

  • Source of the data:
    Independent testing by US Government Laboratories
  • Changes to the source data:
    openFDA may change some field names and converts the data into JSON, which is a widely used machine readable format.
  • Time period covered in this API:
    2020 to present
  • Frequency of API updates:
    Intermittently

Responsible use of the data

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About this testing program

Introduction

The serology tests were tested at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) or by the Hemostasis Laboratory Branch, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention (CDC).

Panel Composition

Each test was evaluated against “Panel 1” or “Panel 2”, each of which include frozen SARS-CoV-2 antibody-positive serum samples (\(n=30\)) and frozen antibody-negative serum and Anticoagulant Citrate Dextrose Solution Formula A (ACD-A) plasma samples (\(n=80\)). The panel size and composition were chosen to enable a laboratory-based evaluation and to provide reasonable estimates and confidence intervals for test performance in the context of limited sample availability. The sample size is comparable to that of a typical sample size used to support Emergency Use Authorization (EUA) by FDA for tests of this type.

Positive samples

Positive samples used were from patients previously confirmed to have SARS-CoV-2 infection with a nucleic acid amplification test (NAAT). Time between symptom onset, NAAT testing, and sample collection is not known for all samples. Both SARS-CoV-2 IgM and IgG antibodies are present in all positive samples used. The Centers for Disease Control and Prevention (CDC) detected the presence of IgG and IgM antibodies at their laboratory using their SARS-CoV-2 spike enzyme-linked immunosorbent assay (ELISA) tests. (See Serology Testing for COVID-19, which notes “CDC’s serologic test is designed and validated for broad-based surveillance and research that will give us information needed to guide the response to the pandemic and protect the public’s health. The test is not currently designed to test individuals who want to know if they have been previously infected with COVID-19.”) The presence of antibodies was confirmed at FNLCR using CDC’s developed ELISAs (Pan-Ig, IgG, and IgM) as well as an IgG Receptor Binding Domain (RBD) ELISA developed by the Krammer Laboratory at the Icahn School of Medicine at Mount Sinai. (An implementation of this test, the COVID-19 ELISA IgG Antibody Test, has been granted an EUA authorization by FDA for use at the Mount Sinai Laboratory (MSL), Center for Clinical Laboratories, a division of the Department of Pathology, Molecular, and Cell-Based Medicine, New York, NY. See this EUA Summary.) The positive samples selected may not reflect the distribution of antibody levels in patient populations that would be evaluated by such a test. Because all samples are positive for both IgM and IgG, this evaluation cannot verify that tests intended to detect IgM and IgG antibodies separately detect these antibodies independently.

Positive samples were assessed at dilutions of 1:100, 1:400, 1:1600, and 1:6400 by CDC on their Pan-Ig assay, their IgM assay, and their IgG assay. Some samples were run at additional dilutions. Any samples that were positive at a dilution greater than 1:6400 were assigned a titer of 6400 because 1:6400 was the highest dilution at which all positive samples were assessed. Two of these samples, C0107 and C0176, were positive for IgG antibodies at a dilution of 1:25600.

Negative Samples

All negative samples used were collected prior to 2020, before the SARS-CoV-2 virus is known to have circulated in the United States. Negative sample groups include:

  • “Negatives” (n=70): selected without regard for clinical status. This group includes a sample, C0063, that showed reactivity in the Pan-Ig CDC spike ELISA at FNLCR. It includes another sample, C0087, that showed reactivity in the IgG RBD ELISA at FNLCR.

  • “HIV+” (n=10): selected from banked serum from HIV+ patients. (HIV+ samples were deemed appropriate for inclusion in the panel: (1) to increase the sample size and reduce the confidence interval; and (2) to identify any possibility of cross-reactivity with HIV+ samples. It is anticipated that other types of samples, as they become available, may also be evaluated in any future analyses.) This group includes 3 samples, C0018, C0155, and C0182, that showed reactivity in the IgG RBD ELISA at FNLCR.

All negative samples were assessed at dilutions of 1:100 and 1:400 by CDC on their Pan-Ig assay. A subset of samples was assessed in parallel at additional dilutions and on the CDC IgM and IgG assays. All negative samples were negative at a dilution of 1:100 on the CDC Pan-Ig assay. These samples were assigned an undetectable titer (represented as zero (0) in the line data) for the Pan-Ig assay, the IgM assay, and the IgG assay.

Analysis

Samples used in this evaluation were not randomly selected, and sensitivity (PPA) and specificity (NPA) estimates shown may not be indicative of the real-world performance of these tests. Sensitivity and specificity were calculated for each antibody (e.g., IgM, IgG, IgA, and Pan Ig, as applicable) separately. In addition, for tests that measure multiple antibodies separately, sensitivity and specificity were estimated in a combined manner, where a positive result for any antibody a test is intended to detect was considered as a positive test result and a negative result meant that a sample tested negative for all antibodies a test is intended to detect. Positive and negative predictive values were calculated for combined sensitivity and specificity for tests that measure multiple antibodies separately and assuming a prevalence of 5%. Cross-reactivity with HIV+ was evaluated, and results are presented separately in the individual test reports. If cross-reactivity was detected, the samples with HIV+ were not included in calculations of specificity.

In this report, device outputs indicating equivocal results, including outputs such as “borderline” or similar, are referred to as “equivocal.” For ELISA tests that provide equivocal results, for sensitivity and specificity calculations, equivocal results on positive samples were counted as false negative results, and equivocal results on negative samples were counted as false positive results.

Confidence intervals for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008). (CLSI. User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline—Second Edition. CLSI document EP12-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2008. See Recognized Consensus Standards.) Confidence intervals for PPV and NPV were calculated using the values from the 95% confidence intervals for sensitivity and specificity. 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. (Statistics with Confidence: Confidence Intervals and Statistical Guidelines. (2013). Wiley.))

Important caveats

Sensitivity and specificity estimates shown may not be indicative of the real world performance of the tests.

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.

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.

Notes about the evaluation procedure

  • The tests were used per the manufacturers’ package inserts.
  • Devices were tested within any expiration dates provided.
  • Devices were not obviously defective / compromised.
  • Devices were stored at FNLCR within their labeled conditions.
  • For lateral flow tests, a single operator conducted and read the test.
  • For ELISA tests, a single operator conducted the test.
  • For lateral flow tests, the operator trained on the test with positive and negative controls prior to testing.
  • For ELISA tests, each test was run with positive and negative controls.
  • The personnel who performed the testing were blinded to the identity / code of the sample and the expected results.
  • The testing was performed in a non-clinical laboratory environment.
  • Negative and positive samples were ordered randomly and then tested serially.

See the individual test reports for more specific information on the evaluation of each test.

Summary test results

Where the Marketing Status below is shown as “EUA Authorized,” FDA has reviewed data generated by the developer and the independent evaluation and determined, among other things, that based on the totality of the evidence available, that the test may be effective in identifying the presence of antibodies to SARS-CoV-2 as described in the Letters of Authorization for each test, and that the known and potential benefits of the test when so used outweigh the known and potential risks. Such tests are authorized by FDA under Emergency Use Authorizations (EUA) and may be distributed and used as set forth in the EUA. Where the Marketing Status below is shown as “Should not be distributed – Voluntarily withdrawn,” the manufacturers have voluntarily stopped distribution and requested FDA to remove their test from the list of commercial manufacturers distributing serology test kits under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests. Where the Marketing Status below is shown as “Should not be distributed – Removed,” either an EUA request has not been submitted within a reasonable period of time as outlined in the Policy for Coronavirus Disease-2019 Tests or FDA has determined not to issue an EUA for the test. Where the Marketing Status below is shown as “Should not be distributed –- No notification or EUA authorization”, the test was evaluated prior to any planned distribution in the United States and is not known to have been marketed here.

EUA Authorized

Abbott Architect i1000 SARS-CoV-2 IgG

Manufacturer: Abbott

Device: Architect i1000 SARS-CoV-2 IgG

Date Performed: 2020-05-20

Lot Number: 15016M800

Panel: Panel 1

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(46.0%; 100%)
IgGNPV at prevalence = 5%99.5%(98.6%; 99.8%)

CDC’s Independent Evaluation Report

Data File

Access Bio Inc. CareStart COVID-19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab

Manufacturer: Access Bio Inc.

Device: CareStart COVID-19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab

Date Performed: 2020-06-02

Lot Number: C120E68

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity90.0% (27/30)(74.4%; 96.5%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedPPV at prevalence = 5%67.8%(34.9%; 88.3%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

Assure Tech. (Hangzhou) Co., Ltd. FaStep Rapid Diagnostic Test Coronavirus Disease 2019/ (COVID-2019) IgG/IgM Rapid Test

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

Device: FaStep Rapid Diagnostic Test Coronavirus Disease 2019/ (COVID-2019) IgG/IgM Rapid Test

Date Performed: 2020-06-10

Lot Number: I2003183

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%81.4%(41.1%; 96.3%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab ELISA

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Device: WANTAI SARS-CoV-2 Ab ELISA

Date Performed: 2020-07-02

Lot Number: NCOA20200401

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan IgSensitivity96.7% (29/30)(83.3%; 99.4%)
Pan IgSpecificity97.5% (78/80)(91.3%; 99.3%)
Pan IgPPV at prevalence = 5%67.1%(33.5%; 88.2%)
Pan IgNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd. WANTAI SARS-CoV-2 Ab Rapid Test

Manufacturer: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Device: WANTAI SARS-CoV-2 Ab Rapid Test

Date Performed: 2020-06-16

Lot Number: JNB20200406

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
Pan IgSensitivity100% (30/30)(88.7%; 100%)
Pan IgSpecificity98.8% (79/80)(93.3%; 99.8%)
Pan IgPPV at prevalence = 5%81.4%(41.1%; 96.3%)
Pan IgNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

Biocan Diagnostics Inc biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

Manufacturer: Biocan Diagnostics Inc

Device: biocan Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

Date Performed: 2020-06-03

Lot Number: B251CB170320

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity90.0% (27/30)(74.4%; 96.5%)
IgMSpecificity98.7% (78/79)(93.2%; 99.8%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity96.2% (76/79)(89.4%; 98.7%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity96.2% (76/79)(89.4%; 98.7%)
CombinedPPV at prevalence = 5%56.4%(28.1%; 79.9%)
CombinedNPV at prevalence = 5%99.6%(98.8%; 99.9%)

NCI’s Independent Evaluation Report

Data File

Biohit Healthcare (Hefei) Co., Ltd. SARS-CoV-2 IgM/IgG Antibody Test Kit

Manufacturer: Biohit Healthcare (Hefei) Co., Ltd.

Device: SARS-CoV-2 IgM/IgG Antibody Test Kit

Date Performed: 2020-05-28

Lot Number: SA200301

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity95.0% (76/80)(87.8%; 98.0%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%50.4%(26.4%; 72.3%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

Euroimmun SARS-COV-2 ELISA (IgG)

Manufacturer: Euroimmun

Device: SARS-COV-2 ELISA (IgG)

Date Performed: 2020-04-21

Lot Number: E200330DT

Panel: Panel 1

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(46.0%; 100%)
IgGNPV at prevalence = 5%99.5%(98.6%; 99.8%)

NCI’s Independent Evaluation Report

Data File

Hangzhou Biotest Biotech, Co., Ltd. Covid-19 IgG/IgM Rapid Test Cassette

Manufacturer: Hangzhou Biotest Biotech, Co., Ltd.

Device: Covid-19 IgG/IgM Rapid Test Cassette

Date Performed: 2020-04-27

Lot Number: COV20030071

Panel: Panel 1

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity100% (80/80)(95.4%; 100%)
CombinedPPV at prevalence = 5%100%(50.4%; 100%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

Hangzhou Laihe Biotech Co., Ltd. Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

Manufacturer: Hangzhou Laihe Biotech Co., Ltd.

Device: Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

Date Performed: 2020-06-10

Lot Number: 2005037

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%81.4%(41.1%; 96.3%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

Healgen COVID-19 IgG/IgM Rapid Test Cassette

Manufacturer: Healgen

Device: COVID-19 IgG/IgM Rapid Test Cassette

Date Performed: 2020-04-21

Lot Number: 2003292

Panel: Panel 1

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedPPV at prevalence = 5%67.8%(34.9%; 88.3%)
CombinedNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

InBios International Inc. SCoV-2 Detect™ IgG ELISA

Manufacturer: InBios International Inc.

Device: SCoV-2 Detect™ IgG ELISA

Date Performed: 2020-06-16

Lot Number: DFT1172

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(50.4%; 100%)
IgGNPV at prevalence = 5%100%(99.4%; 100%)

NCI’s Independent Evaluation Report

Data File

InBios International Inc. SCoV-2 Detect™ IgM ELISA

Manufacturer: InBios International Inc.

Device: SCoV-2 Detect™ IgM ELISA

Date Performed: 2020-06-16

Lot Number: DFT1170

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity96.7% (29/30)(83.3%; 99.4%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgMPPV at prevalence = 5%80.9%(39.6%; 96.3%)
IgMNPV at prevalence = 5%99.8%(99.1%; 100%)

NCI’s Independent Evaluation Report

Data File

Megna Health Inc. Megna Rapid COVID-19 IgM/IgG Combo Test Kit

Manufacturer: Megna Health Inc.

Device: Megna Rapid COVID-19 IgM/IgG Combo Test Kit

Date Performed: 2020-06-24

Lot Number: NA

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity83.3% (25/30)(66.4%; 92.7%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%51.3%(27.7%; 72.5%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

NCI’s Independent Evaluation Report

Data File

Salofa Oy Sienna COVID-19 IgG/IgM Rapid Test Cassette (whole blood/serum/plasma)

Manufacturer: Salofa Oy

Device: Sienna COVID-19 IgG/IgM Rapid Test Cassette (whole blood/serum/plasma)

Date Performed: 2020-06-09

Lot Number: 20052003

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity90.0% (27/30)(74.4%; 96.5%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%80.4%(38.2%; 96.3%)
CombinedNPV at prevalence = 5%99.6%(98.8%; 99.9%)

NCI’s Independent Evaluation Report

Data File

Sugentech, Inc. SGTi-flex COVID-19 IgG

Manufacturer: Sugentech, Inc.

Device: SGTi-flex COVID-19 IgG

Date Performed: 2020-08-19

Lot Number: COGT20104

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(48.8%; 100%)
IgGNPV at prevalence = 5%99.8%(99.1%; 100%)

NCI’s Independent Evaluation Report

Data File

TBG Biotechnology Corp SARS-CoV-2 IgG/IgM Rapid Test Kit

Manufacturer: TBG Biotechnology Corp

Device: SARS-CoV-2 IgG/IgM Rapid Test Kit

Date Performed: 2020-06-16

Lot Number: FRS20051K

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity95.0% (76/80)(87.8%; 98.0%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%49.5%(25.3%; 72.1%)
CombinedNPV at prevalence = 5%99.6%(98.7%; 99.9%)

NCI’s Independent Evaluation Report

Data File

Xiamen Biotime Biotechnology Co., Ltd. Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test

Manufacturer: Xiamen Biotime Biotechnology Co., Ltd.

Device: Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test

Date Performed: 2020-05-29

Lot Number: X2003602

Panel: Panel 2

Marketing Status: EUA Authorized

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedPPV at prevalence = 5%58.1%(30.8%; 80.2%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

NCI’s Independent Evaluation Report

Data File

Should not be Used

Abacus Pharma International SARS-CoV-2 IgM/IgG AB Antibody Rapid Test (Immunochromatography)

Manufacturer: Abacus Pharma International

Device: SARS-CoV-2 IgM/IgG AB Antibody Rapid Test (Immunochromatography)

Date Performed: 2020-05-08

Lot Number: COV1252003C

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity53.3% (16/30)(36.1%; 69.8%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity73.3% (22/30)(55.6%; 85.8%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity76.7% (23/30)(59.1%; 88.2%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%77.1%(31.7%; 95.9%)
CombinedNPV at prevalence = 5%98.8%(97.7%; 99.4%)

NCI’s Independent Evaluation Report

Data File

Abbexa COVID-19 IgG/IgM Rapid Test Kit

Manufacturer: Abbexa

Device: COVID-19 IgG/IgM Rapid Test Kit

Date Performed: 2020-06-04

Lot Number: L20Z4852X

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity53.3% (16/30)(36.1%; 69.8%)
IgMSpecificity96.2% (77/80)(89.5%; 98.7%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity92.5% (74/80)(84.6%; 96.5%)
CombinedPPV at prevalence = 5%40.4%(22.2%; 59.9%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

Abbott Rapid Diagnostics Jena GmbH COVID-19 IgG Rapid Test Device

Manufacturer: Abbott Rapid Diagnostics Jena GmbH

Device: COVID-19 IgG Rapid Test Device

Date Performed: 2020-07-20

Lot Number: COV0062057

Panel: Panel 2

Marketing Status: Should not be distributed –– No notification or EUA authorization

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity83.3% (25/30)(66.4%; 92.7%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(43.2%; 100%)
IgGNPV at prevalence = 5%99.1%(98.2%; 99.6%)

NCI’s Independent Evaluation Report

Data File

Accudiagnostics Covid-19 IgM/IgG Test Kit

Manufacturer: Accudiagnostics

Device: Covid-19 IgM/IgG Test Kit

Date Performed: 2020-04-27

Lot Number: NA

Panel: Panel 1

Marketing Status: Should not be distributed –- No notification or EUA authorization

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity87.5% (70/80)(78.5%; 93.1%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity92.5% (74/80)(84.6%; 96.5%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity82.5% (66/80)(72.7%; 89.3%)
CombinedPPV at prevalence = 5%23.1%(14.6%; 33.0%)
CombinedNPV at prevalence = 5%100%(99.2%; 100%)

NCI’s Independent Evaluation Report

Data File

Alfa Scientific Designs Inc. Covid-19 IgG/IgM Antibody Test

Manufacturer: Alfa Scientific Designs Inc.

Device: Covid-19 IgG/IgM Antibody Test

Date Performed: 2020-04-30

Lot Number: PD200420A

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity93.8% (75/80)(86.2%; 97.3%)
IgGSensitivity80.0% (24/30)(62.7%; 90.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity93.8% (75/80)(86.2%; 97.3%)
CombinedPPV at prevalence = 5%45.9%(25.3%; 66.1%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

NCI’s Independent Evaluation Report

Data File

Arbor Vita Corporation CoVisa™ IgG Test

Manufacturer: Arbor Vita Corporation

Device: CoVisa™ IgG Test

Date Performed: 2020-06-17

Lot Number: RD20060803

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgGSensitivity76.7% (23/30)(59.1%; 88.2%)
IgGSpecificity100% (80/80)(95.4%; 100%)
IgGPPV at prevalence = 5%100%(40.3%; 100%)
IgGNPV at prevalence = 5%98.8%(97.8%; 99.4%)

NCI’s Independent Evaluation Report

Data File

Atlas-Link (Beijing) Nova COVID-19 IgG/IgM Antibody Rapid Test

Manufacturer: Atlas-Link (Beijing)

Device: Nova COVID-19 IgG/IgM Antibody Rapid Test

Date Performed: 2020-04-27

Lot Number: 20200305

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity90.0% (27/30)(74.4%; 96.5%)
IgMSpecificity90.0% (72/80)(81.5%; 94.8%)
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity90.0% (72/80)(81.5%; 94.8%)
CombinedSensitivity90.0% (27/30)(74.4%; 96.5%)
CombinedSpecificity90.0% (72/80)(81.5%; 94.8%)
CombinedPPV at prevalence = 5%32.1%(17.5%; 49.4%)
CombinedNPV at prevalence = 5%99.4%(98.4%; 99.8%)

NCI’s Independent Evaluation Report

Data File

Aurora Biomed Inc COVID-19 IgG/IgM Rapid Test

Manufacturer: Aurora Biomed Inc

Device: COVID-19 IgG/IgM Rapid Test

Date Performed: 2020-05-08

Lot Number: COVID20200424

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity66.7% (20/30)(48.8%; 80.8%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity76.7% (23/30)(59.1%; 88.2%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity76.7% (23/30)(59.1%; 88.2%)
CombinedSpecificity100% (80/80)(95.4%; 100%)
CombinedPPV at prevalence = 5%100%(40.3%; 100%)
CombinedNPV at prevalence = 5%98.8%(97.8%; 99.4%)

NCI’s Independent Evaluation Report

Data File

AutoBio Diagnostics Co., LTD Anti-SARS-CoV-2 Rapid Test

Manufacturer: AutoBio Diagnostics Co., LTD

Device: Anti-SARS-CoV-2 Rapid Test

Date Performed: 2020-06-24

Lot Number: 20E22-J01

Panel: Panel 2

Marketing Status: Should not be distributed – Removed – EUA Revoked

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity50.0% (15/30)(33.2%; 66.8%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%80.4%(38.2%; 96.3%)
CombinedNPV at prevalence = 5%99.6%(98.8%; 99.9%)

NCI’s Independent Evaluation Report

Data File

Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto Rapid Test10 COVID-19 IgG/IgM Rapid Test Kit

Manufacturer: Beijing Kewei Clinical Diagnostic Reagent Inc.

Device: Genonto Rapid Test10 COVID-19 IgG/IgM Rapid Test Kit

Date Performed: 2020-08-06

Lot Number: 202004004

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity91.2% (73/80)(83.0%; 95.7%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity91.2% (73/80)(83.0%; 95.7%)
CombinedPPV at prevalence = 5%35.8%(19.6%; 54.6%)
CombinedNPV at prevalence = 5%99.6%(98.7%; 99.9%)

NCI’s Independent Evaluation Report

Data File

Biolidics Ltd 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

Manufacturer: Biolidics Ltd

Device: 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold)

Date Performed: 2020-05-28

Lot Number: V5020041352A

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity33.3% (10/30)(19.2%; 51.2%)
IgMSpecificity97.5% (77/79)(91.2%; 99.3%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity96.2% (76/79)(89.4%; 98.7%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity96.2% (76/79)(89.4%; 98.7%)
CombinedPPV at prevalence = 5%57.3%(29.3%; 80.1%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

Biomedomics COVID-19 IgM-IgG Rapid Test kit

Manufacturer: Biomedomics

Device: COVID-19 IgM-IgG Rapid Test kit

Date Performed: 2020-04-21

Lot Number: 51-200404

Panel: Panel 1

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity86.7% (26/30)(70.3%; 94.7%)
IgMSpecificity97.1% (68/70)(90.2%; 99.2%)
IgGSensitivity73.3% (22/30)(55.6%; 85.8%)
IgGSpecificity100% (70/70)(94.8%; 100%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity97.1% (68/70)(90.2%; 99.2%)
CombinedPPV at prevalence = 5%63.7%(30.9%; 86.7%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

BioMedomics, Inc. BioMedomics COVID-19 IgM-IgG Rapid Test

Manufacturer: BioMedomics, Inc.

Device: BioMedomics COVID-19 IgM-IgG Rapid Test

Date Performed: 2020-06-02

Lot Number: 51-200511

Panel: Panel 2

Marketing Status: Should not be distributed –– No notification or EUA authorization

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity86.7% (26/30)(70.3%; 94.7%)
IgMSpecificity95.0% (76/80)(87.8%; 98.0%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity92.5% (74/80)(84.6%; 96.5%)
CombinedPPV at prevalence = 5%41.2%(23.3%; 60.1%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

NCI’s Independent Evaluation Report

Data File

ChemBio DPP COVID-19 IgM/IgG System

Manufacturer: ChemBio

Device: DPP COVID-19 IgM/IgG System

Date Performed: 2020-04-21

Lot Number: 204IG001Z

Panel: Panel 1

Marketing Status: Should not be distributed – Removed – EUA Revoked

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity57.1% (16/28)(39.1%; 73.5%)
IgMSpecificity86.2% (69/80)(77.0%; 92.1%)
IgGSensitivity78.6% (22/28)(60.5%; 89.8%)
IgGSpecificity91.2% (73/80)(83.0%; 95.7%)
CombinedSensitivity82.1% (23/28)(64.4%; 92.1%)
CombinedSpecificity81.2% (65/80)(71.3%; 88.3%)
CombinedPPV at prevalence = 5%18.7%(10.6%; 29.3%)
CombinedNPV at prevalence = 5%98.9%(97.4%; 99.5%)

NCI’s Independent Evaluation Report

Data File

Chemtron Biotech, Inc. Rapid COVID-19 IgM/IgG Antibody Screen Test

Manufacturer: Chemtron Biotech, Inc.

Device: Rapid COVID-19 IgM/IgG Antibody Screen Test

Date Performed: 2020-05-08

Lot Number: DA05507401

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity20.0% (6/30)(9.5%; 37.3%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity63.3% (19/30)(45.5%; 78.1%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity66.7% (20/30)(48.8%; 80.8%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%74.5%(27.7%; 95.5%)
CombinedNPV at prevalence = 5%98.3%(97.2%; 99.0%)

NCI’s Independent Evaluation Report

Data File

GenBody Inc. GenBody COVID-19 IgM/IgG

Manufacturer: GenBody Inc.

Device: GenBody COVID-19 IgM/IgG

Date Performed: 2020-06-11

Lot Number: FJFB30201

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity40.0% (12/30)(24.6%; 57.7%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity56.7% (17/30)(39.2%; 72.6%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity60.0% (18/30)(42.3%; 75.4%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%72.5%(24.9%; 95.2%)
CombinedNPV at prevalence = 5%97.9%(96.8%; 98.7%)

NCI’s Independent Evaluation Report

Data File

Genobio Pharmaceutical Co. Ltd Virusee® COVID-19 IgM/IgG Lateral Flow Assay

Manufacturer: Genobio Pharmaceutical Co. Ltd

Device: Virusee® COVID-19 IgM/IgG Lateral Flow Assay

Date Performed: 2020-07-09

Lot Number: VMG200331

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity56.7% (17/30)(39.2%; 72.6%)
IgMSpecificity76.2% (61/80)(65.9%; 84.2%)
IgGSensitivity63.3% (19/30)(45.5%; 78.1%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity80.0% (24/30)(62.7%; 90.5%)
CombinedSpecificity76.2% (61/80)(65.9%; 84.2%)
CombinedPPV at prevalence = 5%15.0%(8.8%; 23.2%)
CombinedNPV at prevalence = 5%98.6%(97.1%; 99.4%)

NCI’s Independent Evaluation Report

Data File

GP Getein Biotech, Inc. One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)

Manufacturer: GP Getein Biotech, Inc.

Device: One Step Test for Novel Coronavirus (2019-nCoV) IgM/IgG antibody (Colloidal Gold)

Date Performed: 2020-05-08

Lot Number: PGGM20015W

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity56.7% (17/30)(39.2%; 72.6%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity73.3% (22/30)(55.6%; 85.8%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity76.7% (23/30)(59.1%; 88.2%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%77.1%(31.7%; 95.9%)
CombinedNPV at prevalence = 5%98.8%(97.7%; 99.4%)

NCI’s Independent Evaluation Report

Data File

Guangzhou Fenghua Bioengineering Co., Ltd. SARS-COV-2 IgM/IgG Combo Rapid Test Kit

Manufacturer: Guangzhou Fenghua Bioengineering Co., Ltd.

Device: SARS-COV-2 IgM/IgG Combo Rapid Test Kit

Date Performed: 2020-06-04

Lot Number: 20200508

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity70.0% (21/30)(52.1%; 83.3%)
IgMSpecificity65.0% (52/80)(54.1%; 74.5%)
IgGSensitivity70.0% (21/30)(52.1%; 83.3%)
IgGSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedSensitivity80.0% (24/30)(62.7%; 90.5%)
CombinedSpecificity62.5% (50/80)(51.5%; 72.3%)
CombinedPPV at prevalence = 5%10.1%(6.4%; 14.7%)
CombinedNPV at prevalence = 5%98.3%(96.3%; 99.3%)

NCI’s Independent Evaluation Report

Data File

H-Guard (China) Co., Ltd. Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)

Manufacturer: H-Guard (China) Co., Ltd.

Device: Novel Coronavirus COVID-19 IgM/IgG Test Kit (colloidal gold)

Date Performed: 2020-06-09

Lot Number: 20200406

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity53.3% (16/30)(36.1%; 69.8%)
IgMSpecificity96.2% (77/80)(89.5%; 98.7%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity93.8% (75/80)(86.2%; 97.3%)
CombinedPPV at prevalence = 5%45.1%(24.1%; 66.0%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

Invenio Medical Inc. COVID-19 IgG/IgM Ab Rapid Test

Manufacturer: Invenio Medical Inc.

Device: COVID-19 IgG/IgM Ab Rapid Test

Date Performed: 2020-05-06

Lot Number: COVID20200424

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity76.7% (23/30)(59.1%; 88.2%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity80.0% (24/30)(62.7%; 90.5%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity80.0% (24/30)(62.7%; 90.5%)
CombinedSpecificity100% (80/80)(95.4%; 100%)
CombinedPPV at prevalence = 5%100%(41.8%; 100%)
CombinedNPV at prevalence = 5%99.0%(98.0%; 99.5%)

NCI’s Independent Evaluation Report

Data File

Jiangsu Dablood Pharmaceutical Co. Ltd COVID-19 IgM/IgG One Step Rapid Test

Manufacturer: Jiangsu Dablood Pharmaceutical Co. Ltd

Device: COVID-19 IgM/IgG One Step Rapid Test

Date Performed: 2020-06-04

Lot Number: NA

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity82.5% (66/80)(72.7%; 89.3%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity81.2% (65/80)(71.3%; 88.3%)
CombinedPPV at prevalence = 5%21.9%(14.0%; 31.0%)
CombinedNPV at prevalence = 5%100%(99.2%; 100%)

NCI’s Independent Evaluation Report

Data File

Jiangsu Superbio Biomedical (Nanjing) Co Ltd SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)

Manufacturer: Jiangsu Superbio Biomedical (Nanjing) Co Ltd

Device: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold)

Date Performed: 2020-06-23

Lot Number: SYG202027

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity40.0% (12/30)(24.6%; 57.7%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity100% (30/30)(88.7%; 100%)
IgGSpecificity85.0% (68/80)(75.6%; 91.2%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity83.8% (67/80)(74.2%; 90.3%)
CombinedPPV at prevalence = 5%24.5%(15.3%; 35.2%)
CombinedNPV at prevalence = 5%100%(99.2%; 100%)

NCI’s Independent Evaluation Report

Data File

LumiQuick Diagnostics Quick Profile 2019-nCoV IgG/IgM Test Card

Manufacturer: LumiQuick Diagnostics

Device: Quick Profile 2019-nCoV IgG/IgM Test Card

Date Performed: 2020-06-03

Lot Number: 20042919

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity86.7% (26/30)(70.3%; 94.7%)
IgMSpecificity93.8% (75/80)(86.2%; 97.3%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity90.0% (72/80)(81.5%; 94.8%)
CombinedPPV at prevalence = 5%33.7%(19.2%; 50.2%)
CombinedNPV at prevalence = 5%99.8%(98.9%; 100%)

NCI’s Independent Evaluation Report

Data File

MEDsan GmbH MEDsan biological health solutions, MEDsan COVID-19 IgM/IgG Rapid Test

Manufacturer: MEDsan GmbH

Device: MEDsan biological health solutions, MEDsan COVID-19 IgM/IgG Rapid Test

Date Performed: 2020-06-01

Lot Number: NA

Panel: Panel 2

Marketing Status: Should not be distributed –– No notification or EUA authorization

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity90.0% (27/30)(74.4%; 96.5%)
IgMSpecificity96.2% (77/80)(89.5%; 98.7%)
IgGSensitivity90.0% (27/30)(74.4%; 96.5%)
IgGSpecificity93.8% (75/80)(86.2%; 97.3%)
CombinedSensitivity90.0% (27/30)(74.4%; 96.5%)
CombinedSpecificity92.5% (74/80)(84.6%; 96.5%)
CombinedPPV at prevalence = 5%38.7%(20.3%; 59.2%)
CombinedNPV at prevalence = 5%99.4%(98.4%; 99.8%)

NCI’s Independent Evaluation Report

Data File

Nanjing Vazyme Medical Technology Co. LTD Vazyme 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)

Manufacturer: Nanjing Vazyme Medical Technology Co. LTD

Device: Vazyme 2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based)

Date Performed: 2020-05-29

Lot Number: 5020042252B

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity66.7% (20/30)(48.8%; 80.8%)
IgMSpecificity77.5% (62/80)(67.2%; 85.3%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity90.0% (72/80)(81.5%; 94.8%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity68.8% (55/80)(57.9%; 77.9%)
CombinedPPV at prevalence = 5%14.0%(9.4%; 19.1%)
CombinedNPV at prevalence = 5%99.7%(98.5%; 100%)

NCI’s Independent Evaluation Report

Data File

PCL, Inc. PCL COVID19 IgG/IgM Rapid Gold

Manufacturer: PCL, Inc.

Device: PCL COVID19 IgG/IgM Rapid Gold

Date Performed: 2020-06-04

Lot Number: COV03-200325

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity100% (70/70)(94.8%; 100%)
IgGSensitivity80.0% (24/30)(62.7%; 90.5%)
IgGSpecificity100% (70/70)(94.8%; 100%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity100% (70/70)(94.8%; 100%)
CombinedPPV at prevalence = 5%100%(45.7%; 100%)
CombinedNPV at prevalence = 5%99.8%(99.1%; 100%)

NCI’s Independent Evaluation Report

Data File

Phamatech COVID19 RAPID TEST

Manufacturer: Phamatech

Device: COVID19 RAPID TEST

Date Performed: 2020-04-21

Lot Number: NCP20030239

Panel: Panel 1

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity26.7% (8/30)(14.2%; 44.4%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity86.7% (26/30)(70.3%; 94.7%)
IgGSpecificity96.2% (77/80)(89.5%; 98.7%)
CombinedSensitivity86.7% (26/30)(70.3%; 94.7%)
CombinedSpecificity93.8% (75/80)(86.2%; 97.3%)
CombinedPPV at prevalence = 5%42.4%(21.1%; 64.9%)
CombinedNPV at prevalence = 5%99.3%(98.2%; 99.7%)

NCI’s Independent Evaluation Report

Data File

RayBiotech Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit (Colloidal Gold Method)

Manufacturer: RayBiotech

Device: Novel Coronavirus (SARS-CoV-2) IgM and IgG Dual Combined Antibody Detection Kit (Colloidal Gold Method)

Date Performed: 2020-06-01

Lot Number: 0505202977

Panel: Panel 2

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity60.0% (18/30)(42.3%; 75.4%)
IgMSpecificity57.5% (46/80)(46.6%; 67.7%)
IgGSensitivity46.7% (14/30)(30.2%; 63.9%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity70.0% (21/30)(52.1%; 83.3%)
CombinedSpecificity57.5% (46/80)(46.6%; 67.7%)
CombinedPPV at prevalence = 5%8.0%(4.9%; 12.0%)
CombinedNPV at prevalence = 5%97.3%(94.9%; 98.7%)

NCI’s Independent Evaluation Report

Data File

SD BIOSENSOR, Inc. STANDARD Q COVID-19 IgM/IgG Duo

Manufacturer: SD BIOSENSOR, Inc.

Device: STANDARD Q COVID-19 IgM/IgG Duo

Date Performed: 2020-05-06

Lot Number: QC01020007/sub : A-2

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity53.3% (16/30)(36.1%; 69.8%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity73.3% (22/30)(55.6%; 85.8%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity76.7% (23/30)(59.1%; 88.2%)
CombinedSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedPPV at prevalence = 5%77.1%(31.7%; 95.9%)
CombinedNPV at prevalence = 5%98.8%(97.7%; 99.4%)

NCI’s Independent Evaluation Report

Data File

Shanghai Fosun Long March Medical Science Co., Ltd. Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit

Manufacturer: Shanghai Fosun Long March Medical Science Co., Ltd.

Device: Fosun COVID-19 IgG/IgM Rapid Antibody Detection Kit

Date Performed: 2020-05-08

Lot Number: 20200302

Panel: Panel 1

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity10.0% (3/30)(3.5%; 25.6%)
IgMSpecificity96.2% (77/80)(89.5%; 98.7%)
IgGSensitivity36.7% (11/30)(21.9%; 54.5%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity36.7% (11/30)(21.9%; 54.5%)
CombinedSpecificity95.0% (76/80)(87.8%; 98.0%)
CombinedPPV at prevalence = 5%27.9%(8.6%; 58.9%)
CombinedNPV at prevalence = 5%96.6%(95.5%; 97.6%)

NCI’s Independent Evaluation Report

Data File

Sugentech, Inc. Sugentech SGTi-flex COVID-19 IgM/IgG

Manufacturer: Sugentech, Inc.

Device: Sugentech SGTi-flex COVID-19 IgM/IgG

Date Performed: 2020-05-28

Lot Number: COVT20906

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity90.0% (72/80)(81.5%; 94.8%)
IgGSensitivity93.3% (28/30)(78.7%; 98.2%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity90.0% (72/80)(81.5%; 94.8%)
CombinedPPV at prevalence = 5%34.5%(20.1%; 50.3%)
CombinedNPV at prevalence = 5%100%(99.3%; 100%)

NCI’s Independent Evaluation Report

Data File

TESTSEALABS SARS-COV-2-IgG/IgM Test Cassette

Manufacturer: TESTSEALABS

Device: SARS-COV-2-IgG/IgM Test Cassette

Date Performed: 2020-04-21

Lot Number: 20200320

Panel: Panel 1

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity73.3% (22/30)(55.6%; 85.8%)
IgMSpecificity98.8% (79/80)(93.3%; 99.8%)
IgGSensitivity40.0% (12/30)(24.6%; 57.7%)
IgGSpecificity93.8% (75/80)(86.2%; 97.3%)
CombinedSensitivity83.3% (25/30)(66.4%; 92.7%)
CombinedSpecificity92.5% (74/80)(84.6%; 96.5%)
CombinedPPV at prevalence = 5%36.9%(18.5%; 58.2%)
CombinedNPV at prevalence = 5%99.1%(98.0%; 99.6%)

NCI’s Independent Evaluation Report

Data File

Tianjin Beroni Biotechnology Co., Ltd. SARS-COV-2 IgG/IgM Antibody Detection Kit

Manufacturer: Tianjin Beroni Biotechnology Co., Ltd.

Device: SARS-COV-2 IgG/IgM Antibody Detection Kit

Date Performed: 2020-04-21

Lot Number: 20200405 (Test Strip)

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity83.3% (25/30)(66.4%; 92.7%)
IgMSpecificity100% (70/70)(94.8%; 100%)
IgGSensitivity30.0% (9/30)(16.7%; 47.9%)
IgGSpecificity100% (70/70)(94.8%; 100%)
CombinedSensitivity90.0% (27/30)(74.4%; 96.5%)
CombinedSpecificity100% (70/70)(94.8%; 100%)
CombinedPPV at prevalence = 5%100%(43.0%; 100%)
CombinedNPV at prevalence = 5%99.5%(98.6%; 99.8%)

NCI’s Independent Evaluation Report

Data File

Tianjin New Bay Bioresearch C. #1 Quik Pac II COVID-19 IgG & IgM Test

Manufacturer: Tianjin New Bay Bioresearch C. #1

Device: Quik Pac II COVID-19 IgG & IgM Test

Date Performed: 2020-06-10

Lot Number: 2005059

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity73.3% (22/30)(55.6%; 85.8%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedPPV at prevalence = 5%67.1%(33.5%; 88.2%)
CombinedNPV at prevalence = 5%99.8%(99.0%; 100%)

NCI’s Independent Evaluation Report

Data File

W.H.P.M, Inc. Covisure Covid-19 IgM/IgG Rapid Test

Manufacturer: W.H.P.M, Inc.

Device: Covisure Covid-19 IgM/IgG Rapid Test

Date Performed: 2020-04-27

Lot Number: P0406203922

Panel: Panel 1

Marketing Status: Should not be distributed – Removed from Notification List

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity76.7% (23/30)(59.1%; 88.2%)
IgMSpecificity97.1% (68/70)(90.2%; 99.2%)
IgGSensitivity70.0% (21/30)(52.1%; 83.3%)
IgGSpecificity97.1% (68/70)(90.2%; 99.2%)
CombinedSensitivity76.7% (23/30)(59.1%; 88.2%)
CombinedSpecificity97.1% (68/70)(90.2%; 99.2%)
CombinedPPV at prevalence = 5%58.2%(24.1%; 85.3%)
CombinedNPV at prevalence = 5%98.8%(97.7%; 99.4%)

NCI’s Independent Evaluation Report

Data File

Wuhan Easy Diagnosis Biomedicine Co. Ltd. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit

Manufacturer: Wuhan Easy Diagnosis Biomedicine Co. Ltd.

Device: COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit

Date Performed: 2020-06-11

Lot Number: 20030401

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity100% (30/30)(88.7%; 100%)
IgMSpecificity88.8% (71/80)(80.0%; 94.0%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity98.8% (79/80)(93.3%; 99.8%)
CombinedSensitivity100% (30/30)(88.7%; 100%)
CombinedSpecificity87.5% (70/80)(78.5%; 93.1%)
CombinedPPV at prevalence = 5%29.6%(17.8%; 43.3%)
CombinedNPV at prevalence = 5%100%(99.2%; 100%)

NCI’s Independent Evaluation Report

Data File

Zhongshan Bio-Tech Co LTD SARS-CoV-2 IgM-IgG (GICA)

Manufacturer: Zhongshan Bio-Tech Co LTD

Device: SARS-CoV-2 IgM-IgG (GICA)

Date Performed: 2020-06-03

Lot Number: 2020007

Panel: Panel 2

Marketing Status: Should not be distributed –– No notification or EUA authorization

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity50.0% (15/30)(33.2%; 66.8%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity96.7% (29/30)(83.3%; 99.4%)
IgGSpecificity85.0% (68/80)(75.6%; 91.2%)
CombinedSensitivity96.7% (29/30)(83.3%; 99.4%)
CombinedSpecificity83.8% (67/80)(74.2%; 90.3%)
CombinedPPV at prevalence = 5%23.9%(14.5%; 35.0%)
CombinedNPV at prevalence = 5%99.8%(98.8%; 100%)

NCI’s Independent Evaluation Report

Data File

Zhuhai Livzon Diagnostic Inc. IgM/IgG Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-COV-2)

Manufacturer: Zhuhai Livzon Diagnostic Inc.

Device: IgM/IgG Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-COV-2)

Date Performed: 2020-05-06

Lot Number: CK2004240410

Panel: Panel 1

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity93.3% (28/30)(78.7%; 98.2%)
IgMSpecificity100% (80/80)(95.4%; 100%)
IgGSensitivity63.3% (19/30)(45.5%; 78.1%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity93.3% (28/30)(78.7%; 98.2%)
CombinedSpecificity100% (80/80)(95.4%; 100%)
CombinedPPV at prevalence = 5%100%(47.4%; 100%)
CombinedNPV at prevalence = 5%99.6%(98.8%; 99.9%)

NCI’s Independent Evaluation Report

Data File

Zhuhai Livzon Diagnostics Inc Livzon IgM/IgG Diagnostic Kit for IgM/IgG Antibody to Coronovirus (SARS-Cov-2) Lateral Flow

Manufacturer: Zhuhai Livzon Diagnostics Inc

Device: Livzon IgM/IgG Diagnostic Kit for IgM/IgG Antibody to Coronovirus (SARS-Cov-2) Lateral Flow

Date Performed: 2020-06-03

Lot Number: CK2004350410

Panel: Panel 2

Marketing Status: Should not be distributed – Voluntarily withdrawn

AntibodyPerformance MeasureEstimate of Performance95% Confidence Interval
IgMSensitivity86.7% (26/30)(70.3%; 94.7%)
IgMSpecificity97.5% (78/80)(91.3%; 99.3%)
IgGSensitivity66.7% (20/30)(48.8%; 80.8%)
IgGSpecificity100% (80/80)(95.4%; 100%)
CombinedSensitivity86.7% (26/30)(70.3%; 94.7%)
CombinedSpecificity97.5% (78/80)(91.3%; 99.3%)
CombinedPPV at prevalence = 5%64.6%(29.8%; 87.7%)
CombinedNPV at prevalence = 5%99.3%(98.3%; 99.7%)

NCI’s Independent Evaluation Report

Data File

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General information: Learn more about EUA Authorized Serology Test Performance