(For Medical Professional Use in CLIA Moderate - To High- Complexity Settings Only)
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.
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
● Buffer included
● Clinical Evaluation
○ 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
DESCRIPTION COVID-19 IgG/IgM Rapid Test
SPECIMEN Whole Blood /Serum/Plasma
UOM 25 Tests/Kit
1. The product can only be used in Laboratories certified under the Clinical Laboratories Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a to perform moderate or high complexity tests.
2. The product is not authorized for “at-home” use and cannot be sold over the internet.
3. The product cannot be used with a capillary blood/finger stick sample.
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.
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