Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
Procedural internal control included
Sensitivity: IgG 97.2%; IgM 87.9%
Specificity: IgG 100%; IgM 100%
Specimen: Whole Blood, Serum, Plasma
Time to Results: 10 minutes
Shelf Life: 24 months from the date of manufacture
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used 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 COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
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) are can be transmitted from between non-human vertebrates to humans.
How accurate is COVID-19 IgG/IgM Rapid Test Device?
The COVID-19 IgG/IgM has been evaluated with the 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms.
The sensitivity of the IgM test is 87.9% and specificity 100% when compared to RT-PCR.
The sensitivity of the IgG test is 97.2% during the convalescence period, and specificity is 100%.
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.
Instructions for Use:
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay the device on a flat surface and add specimen (see specific instructions for each specimen type below):
a. For Serum or Plasma Specimen: With the 5 μL 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 (Venous): Hold the 5 μL 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.
Use fresh samples only.
This test has been validated and independent review by the FDA has been completed.
Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
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. Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected results.
Not for the screening of donated blood
A medical professional is required to consider various factors, including confirmation testing, when receiving a presumptive result.
Note: This Test must be administered by a Medical Professional