16 COVID-19 Serological Tests approved by FDA

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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.

The performance of these tests is described by their “sensitivity,” or their ability to identify those with antibodies to SARS-CoV-2 (true positive rate), and their “specificity,” or their ability to identify those without antibodies to SARS-CoV-2 (true negative rate). A test’s sensitivity can be estimated by determining whether or not it is able to detect antibodies in blood samples from patients who have been confirmed to have COVID-19 with a nucleic acid amplification test, or NAAT. In some validation studies of these tests, like the one FDA is conducting in partnership with NIH, CDC, and BARDA, the samples used, in addition to coming from patients confirmed to have COVID-19 by a NAAT, may also be confirmed to have antibodies present using other serology tests. A test’s specificity can be estimated by testing large numbers of samples collected and frozen before SARS-CoV-2 is known to have circulated to demonstrate that the test does not produce positive results in response to the presence of other causes of a respiratory infection, such as other coronaviruses.

These estimates of sensitivity and specificity are just that: estimates. They include 95% confidence intervals, which are the range of estimates we are about 95% sure a test’s sensitivity and specificity will fall within given how many samples were used in the performance validation. The more samples used to validate a test, the smaller the confidence interval becomes, meaning that we can be more confident in the estimates of sensitivity and specificity provided.

Tests are also described by their Positive and Negative Predictive values (PPV and NPV). These measures are calculated using a test’s sensitivity, its specificity, and using an assumption about the percentage of individuals in the population who have antibodies to SARS-CoV-2 (which is called “prevalence” in these calculations). Every test returns some false positive and false negative results. The PPV and NPV help those who are interpreting these tests understand, given how prevalent individuals with antibodies are in a population, how likely it is that a person who receives a positive result from a test truly does have antibodies to SARS-CoV-2 and how likely it is that a person who receives a negative result from a test truly does not have antibodies to SARS-CoV-2. The PPV and NPV of a test depend heavily on the prevalence of what that test is intended to detect. Because all tests will return some false positive and some false negative results, including tests that detect antibodies to SARS-CoV-2, broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.

We do not currently know the prevalence of SARS-CoV-2 antibody positive individuals in the U.S. population, and prevalence may change based on the duration the virus is in the country and the effectiveness of mitigations. Moreover, prevalence may vary widely between locations and between different groups of people, such as health care workers, due to different rates of infection. In low prevalence populations, which will be much of the asymptomatic general population, the result of a single antibody test is not likely to be sufficiently accurate to make an informed decision regarding whether or not an individual has had a prior infection or truly has antibodies to the virus. A second test, typically one assessing for the presence of antibodies to a different viral protein, generally would be needed to increase the accuracy of the overall testing results.

For this page, FDA has summarized the expected performance of the tests it has authorized based on the information FDA reviewed when deciding whether or not to grant these tests an Emergency Use Authorization and assuming a prevalence of 5% for PPV and NPV calculations. For tests that had multiple validation studies or where the tests showed variable performance in samples collected at different times after symptom onset, FDA experts selected the results they considered to be most representative of expected test performance. This is an incomplete representation of the performance of these tests. Always refer to the complete instructions for use to put these estimates into the proper context and to understand how to use and interpret these tests. FDA also is providing a calculator that will allow users to see the estimated performance of a single test or two independent tests based on their performance characteristics and the estimated prevalence of SARS-CoV-2 antibodies in the target population.

Test Performance

Abbott Alinity i SARS-CoV-2 IgG

Developer: Abbott
Test: Alinity i SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (34/34) (89.9%; 100%)
IgG Specificity (NPA) 99.0% (99/100) (94.6%; 99.8%)
IgG PPV at prevalence = 5% 84.0% (46.7%; 96.3%)
IgG NPV at prevalence = 5% 100% (99.4%; 100%)

Test Facts:

Abbott Architect SARS-CoV-2 IgG

Developer: Abbott
Test: Architect SARS-CoV-2 IgG
Technology: High Throughput CMIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 100% (88/88) (95.8%; 100%)
IgG Specificity (NPA) 99.6% (1066/1070) (99.0%; 99.9%)
IgG PPV at prevalence = 5% 92.9% (83.4%; 98.1%)
IgG NPV at prevalence = 5% 100% (99.8%; 100%)

Test Facts:


Autobio Anti-SARS-CoV-2 Rapid Test

Developer: Autobio
Test: Anti-SARS-CoV-2 Rapid Test
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 95.7% (289/302) (92.8%; 97.5%)
IgM Specificity (NPA) 99.7% (311/312) (98.2%; 99.9%)
IgG Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%)
IgG Specificity (NPA) 99.4% (310/312) (97.7%; 99.8%)
Combined Sensitivity (PPA) 99.0% (299/302) (97.1%; 99.7%)
Combined Specificity (NPA) 99% (309/312) (97.2%; 99.7%)
Combined PPV at prevalence = 5% 84.4% (64.6%; 94.6%)
Combined NPV at prevalence = 5% 99.9% (99.8%; 100%)

Test Facts:


Bio-Rad Platelia SARS-CoV-2 Total Ab

Developer: Bio-Rad Laboratories, Inc
Test: Platelia SARS-CoV-2 Total Ab
Technology: ELISA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 92.2% (47/51) (81.5%; 96.9%)
Pan-Ig Specificity (NPA) 99.6% (684/687) (98.7%; 99.9%)
Pan-Ig PPV at prevalence = 5% 91.7% (76.7%; 98.1%)
Pan-Ig NPV at prevalence = 5% 99.6% (99.0%; 99.8%)

Test Facts:


Cellex qSARS-CoV-2 IgG/IgM Rapid Test

Developer: Cellex, Inc.
Test: qSARS-CoV-2 IgG/IgM Rapid Test
Technology: Lateral Flow
Target: Spike and Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Combined Sensitivity (PPA) 93.8% (120/128) (88.2%; 96.8%)
Combined Specificity (NPA) 96.0% (240/250) (92.8%; 97.8%)
Combined PPV at prevalence = 5% 55.2% (39.2%; 69.8%)
Combined NPV at prevalence = 5% 99.7% (99.3%; 99.8%)

Test Facts:


Chembio Diagnostic Systems DPP Covid-19 IgM/IgG System

Developer: Chembio Diagnostic Systems, Inc.
Test: DPP Covid-19 IgM/IgG System
Technology: Lateral Flow with Reader
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity (PPA) 77.4% (24/31) (60.2%; 88.6%)
IgG Sensitivity (PPA) 87.1% (27/31) (71.1%; 94.9%)
Combined Sensitivity (PPA) 93.5% (29/31) (79.3%; 98.2%)
Combined Specificity (NPA) 94.4% (118/125) (88.9%; 97.3%)
Combined PPV at prevalence = 5% 46.8% (27.3%; 65.7%)
Combined NPV at prevalence = 5% 99.6% (98.8%; 99.9%)

Test Facts:


DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG

Developer: DiaSorin
Test: LIAISON SARS-CoV-2 S1/S2 IgG
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 97.6% (40/41) (87.4%; 99.6%)
IgG Specificity (NPA) 99.3% (1082/1090) (98.6%; 99.6%)
IgG PPV at prevalence = 5% 88.0% (76.7%; 92.9%)
IgG NPV at prevalence = 5% 99.9% (99.3%; 100%)

Test Facts:


EUROIMMUN SARS-COV-2 ELISA (IgG)

Developer: EUROIMMUN
Test: SARS-COV-2 ELISA (IgG)
Technology: ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity 90.0% (27/30) (74.4%; 96.5%)
IgG Specificity 100% (80/80) (95.4%; 100%)
IgG PPV at prevalence = 5% 100% (46.0%; 100%)
IgG NPV at prevalence = 5% 99.5% (98.6%; 99.8%)

Test Facts:


Healgen COVID-19 IgG/IgM Rapid Test Cassette

Developer: Healgen
Test: COVID-19 IgG/IgM Rapid Test Cassette
Technology: Lateral Flow
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined PPV at prevalence = 5% 67.8% (35.0%; 88.4%)
Combined NPV at prevalence = 5% 100% (99.4%; 100%)

Test Facts:


Mount Sinai Hospital Clinical Laboratory COVID-19 ELISA Antibody Test

Developer: Mount Sinai Hospital Clinical Laboratory
Test: Mt. Sinai Laboratory COVID-19 ELISA Antibody Test
Technology: 2-Step ELISA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Combined Sensitivity (PPA) 92.5% (37/40) (80.1%; 97.4%)
Combined Specificity (NPA) 100% (74/74) (95.1%; 100%)
Combined PPV at prevalence = 5% 100% (46.2%; 100%)
Combined NPV at prevalence = 5% 99.6% (98.9%; 99.9%)

Test Facts:


Ortho-Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG test

Developer: Ortho-Clinical Diagnostics, Inc.
Test: VITROS Anti-SARS-CoV-2 IgG test
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
IgG Sensitivity (PPA) 90.0% (36/40) (76.9%; 96.0%)
IgG Specificity (NPA) 100% (407/407) (99.1%; 100%)
IgG PPV at prevalence = 5% 100% (81.8%; 100%)
IgG NPV at prevalence = 5% 99.5% (98.8%; 99.7%)

Test Facts:


Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator

Developer: Ortho-Clinical Diagnostics, Inc.
Test: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator
Technology: High Throughput CLIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (49/49) (92.7%; 100%)
Pan-Ig Specificity (NPA) 100% (400/400) (99.0%; 100%)
Pan-Ig PPV at prevalence = 5% 100% (83.0.%; 100%)
Pan-Ig NPV at prevalence = 5% 100% (99.6%; 100%)

Test Facts:


Roche Elecsys Anti-SARS-CoV-2

Developer: Roche
Test: Elecsys Anti-SARS-CoV-2
Technology: High Throughput ECLIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 100% (29/29) (88.3%; 100%)
Pan-Ig Specificity (NPA) 99.8% (5262/5272) (99.7%; 99.9%)
Pan-Ig PPV at prevalence = 5% 96.5% (93.9%; 98.1%)
Pan-Ig NPV at prevalence = 5% 100% (99.4%; 100%)

Test Facts:


Siemens Healthcare Diagnostics ADVIA Centaur SARS-CoV-2 Total (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: ADVIA Centaur SARS-CoV-2 Total (COV2T)
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 100% (47/47) (92.4%; 100%)
Pan-Ig Specificity 99.8% (1586/1589) (99.4%; 99.9%)
Pan-Ig PPV at prevalence = 5% 96.5% (89.8%; 98.8%)
Pan-Ig NPV at prevalence = 5% 100% (99.6%; 100%)

Test Facts:


Siemens Healthcare Diagnostics Atellica IM SARS-CoV-2 Total (COV2T)

Developer: Siemens Healthcare Diagnostics
Test: Atellica IM SARS-CoV-2 Total (COV2T)
Technology: High Throughput CMIA
Target: Spike

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity 100% (42/42) (91.6%; 100%)
Pan-Ig Specificity 99.8% (1089/1091) (99.3%; 99.9%)
Pan-Ig PPV at prevalence = 5% 96.7% (87.9%; 99.1%)
Pan-Ig NPV at prevalence = 5% 100% (99.6%; 100%)

Test Facts:


Wadsworth New York SARS-CoV Microsphere Immunoassay for Antibody Detection

Developer: Wadsworth Center, New York State Department of Health
Test: New York SARS-CoV Microsphere Immunoassay for Antibody Detection
Technology: MIA
Target: Nucleocapsid

Antibody Performance Measure Estimate of Performance 95% Confidence Interval
Pan-Ig Sensitivity (PPA) 88.0% (95/108) (80.5%; 92.8%)
Pan-Ig Specificity (NPA) 98.8% (428/433) (97.3%; 99.5%)
Pan-Ig PPV at prevalence = 5% 79.4% (61.1%; 90.7%)
Pan-Ig NPV at prevalence = 5% 99.4% (99.0%; 99.6%)

Test Facts:


A note about the performance measures calculated:

In some cases, there may be minor differences between the numbers on this page and those in the instructions for use. Confidence intervals for sensitivity and specificity that appear on this page were calculated per a score method described in CLSI EP12-A2 (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.

 

Continue at: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/eua-authorized-serology-test-performance

 

 

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