eTable 3.
| PRODUCT‡ | TEST AT HOME | ACCESSIBILITY | METHOD | RESULTS READING | SAMPLE TYPE | TAREGET ANTIBODY§ | PERFORMANCE EVIDENCE FOR SARS-CoV-2¶ | TIME TO RESULSTS |
|---|---|---|---|---|---|---|---|---|
| MidaSpot COVID-19 Antibody Combo Detection Kit | No | Health care provider# | Lateral flow | Visual | Fingerstick whole blood | IgM and IgG | IgM NPA∗∗: 97.7% (95% CI,†† 91.8% to 100%) IgG NPA: 100% (95% CI, 92.0% to 100%) 8-14 d IgM PPA‡‡: 100.0% (95% CI, 63.1% to 100.0%) IgG PPA: 75% (95% CI, 40.9% to 92.7%) ≥ 15 d IgM PPA: 100.0% (95% CI, 88.4% to 100.0%) IgG PPA: 100% (95% CI, 88.6% to 100%) |
20 min |
| RapCov Rapid COVID-19 Test | No | Health care provider | Lateral flow | Visual | Fingerstick whole blood | IgG | PPA: 90.0% (95% CI, 73.6% to 97.3%) NPA: 95.2% (95% CI, 89.2% to 97.9%) |
15 min |
| Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette | No | Health care provider | Lateral flow | Visual | Fingerstick whole blood | IgM and IgG | Multiple clinical performance data. See the instructions for use. §§ | 10 min |
| RightSign COVID-19 IgG/IgM Rapid Test Cassette | No | Health care provider | Lateral flow | Visual | Fingerstick whole blood | IgM and IgG | IgM PPA: 88.89% (95% CI, 75.95% to 96.29%) IgM NPA:100.00% (95% CI, 91.06% to 100.00%) IgG PPA: 91.11% (95% CI, 78.78% to 97.52%) IgG NPA:100.00% (95% CI, 91.06% to 100.00%) |
10 min |
| Assure COVID-19 IgG/IgM Rapid Test Device | No | Health care provider | Lateral flow | Visual | Fingerstick whole blood | IgM and IgGs | IgM NPA: 100% (95% CI. 97.7% to 100%) IgG NPA: 100% (95% CI, 97.7% to 100%) 8-14 d IgM PPA: 83.3% (95% CI, 55.2% to 95.3%) IgG PPA: 83.3% (95% CI, 55.2% to 95.3%) ≥ 15 d IgM PPA: 89.3% (95% CI, 72.8% to 96.3%) IgG PPA: 100% (95% CI, 91.2% to 100%) |
15 min |
POC: Point-of-care.
As of April 5, 2021. An up-to-date list of POC antigen diagnostic tests is available online at the US Food and Drug Administration’s “In Vitro Diagnostics EUAs: Serology and Other Adaptive Immune Response Tests for SARS-CoV-2.”9 Those tests that have W in the Authorized Setting column are authorized for POC use. The link for each product’s user instruction is provided in the Authorization Documents section.
Products are listed according to the authorization date.
Results from antibody testing should not be used to diagnose or exclude severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or to inform infection status.
For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results. In the early onset of symptom, anti-SARS-Cov-2 immunoglobulin M (IgM) and immunoglobulin G (IgG) antibody concentrations may be below detectable levels. SARS-CoV-2 IgG antibodies may be below detectable levels in patients who have been exhibiting symptoms for less than 15 days. Results from immunosuppressed patients should be interpreted with caution. False-positive results may be due to cross-reactivity with past or present infection with non-SARS-CoV-2 strains, such as coronaviruses HKU1, NL63, OC43, or 229E. Other information should be considered, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
A health care provider includes, but is not limited to, physicians, dentists, nurses, pharmacists, technologists, laboratory directors, epidemiologists, or any other practitioners or allied health care professionals. The Centers for Disease Control and Prevention provides an online guideline for the collecting and handling of clinical specimens for COVID-19 testing.36
NPA: Negative percentage agreement.
CI: Confidence interval.
PPA: Positive percentage agreement.
Refer to product catalog for further information.