COVID-19 IgG/IgM Rapid Test Cassette
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for SARS-CoV-2 antibodies.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) can be transmitted from between non-human vertebrates to humans.
Internal, procedural control.
Changes from blue to red.
Detects IgG and IgM separately.
Receives donor sample.
Receives buffer solution (included in kit).
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
This product has been authorized only for detecting the presence of IgG and IgM antibodies to SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this product 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Fact Sheet for Healthcare Providers
Fact Sheet for Recipients
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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.
Detection Window (IgM): 3-5 days after incubation
Dual band results for simple interpretation
Multivariable analysis of immunoglobin IgG & IgM
Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
Procedural internal control included
Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
Clinical Agreement with Characterized Samples
Sensitivity: IgG 96.7%; IgM 100%; Combined 100%
Specificity: IgG 97.5%; IgM 100%; Combined 97.5%
Specimen: Whole Blood, Serum, Plasma
Time to Results: 10 minutes
Shelf Life: 24 months from the date of manufacture
COVID-19 IgG/IgM Rapid Test
Whole Blood /Serum/Plasma
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use.
What is the significance of the various test results?
IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
IgM positive, IgG positive/negative: Acute or recent infection.
IgM negative, IgG positive: Previous, distant infection.