How does the coronavirus rapid test work?
It is widely accepted that Immunoglobulin M (IgM) provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. Therefore, testing of COVID-19 IgM and IgG antibodies is a tool that can be used in detecting the COVID-19 infection.
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- Detection of IgM antibodies tends to indicate a recent exposure to COVID-19.
- Detection of IgG antibodies indicates a later stage of infection.
Instructions for Use:
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):
a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
Performance statistics
| 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%) |
Warning
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
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.
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.
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This product is intended for professional use and not for home use.
Not for the screening of donated blood.