COVID-19 IgG/IgM Rapid Test Cassette (Pack of 25)

⚕️For Professional Use Only ⚕️

FDA Authorization Letter (EUA)

Rapid results in 2-10 minutes

Sensitivity of IgM test 1s 87.9% (87/99) and specificity is 100% (14/14) when compared to RT-PCR

Sensitivity of IgG test is 97.2% 35/36 during the convalescence period, ands specificity is 100% (14/14)

Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days

Kit can be stored at room temperature or refrigerated (2-30°C) for up to 24 months from manufacture date

Disclosure:
The test has not been reviewed by the FDA and 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. On 3/23/20, the FDA acknowledged receipt of the necessary intent to launch notices for this testing kit so it may be utilized under the FDA’s Emergency Use Authorization.  For additional information regarding the FDA’s EUA for In Vitro Diagnostic Products, please visit this link.

Quantity: 25 tests per box

$675.00

Category:

Description

Coronavirus Rapid Test Kit (25 Test Box)

COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

Procedure & Explanation

Clinical Evaluation Results

The clinical evaluation was carried out during February 2020 across 10 hospitals and reported on March 12, 2020. The results show that the testing reagent and reference reagent have equivalent effectiveness in detecting COVID-19 when tested in the same clinical specimens.

Compared with the reference reagent, the positive agreement was 93.87% 95%CI:90.24%~96.46%), the negative agreement was 99.10% (95%CI:97.70%~99.75%) and total agreement was 97.19% (95%CI:95.65%~98.26%).

The kappa value of the consistency analysis was 0.94 (95%CI:95.65%~98.26%). The results of the clinical evaluation show that the two reagents (methods) have a high degree of consistency and equivalent sensitivity and specificity in detecting COVID-19.

COVID-19 IgG/IgM RAPID TEST CASSETTE INSTRUCTIONS FOR USE

Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

Place the test device on a clean and level surface.

(For Whole Blood Specimen): Hold the 5 μL mini plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the specimen well(S) of the test device, then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

(For Serum or Plasma Specimens): With a 5 μL mini plastic dropper provided, draw serum/plasma specimen to exceed the specimen line as showed in the following image and then transfer drawn serum/plasma specimen into the sample well (S). Then add 2 drops (about 80 μL) of sample buffer to the buffer well (B) immediately. Avoid air bubbles.

Wait for the colored line(s) to appear. The result should be read in 10 minutes. Positive results may be visible as soon as 2 minutes. Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

Negative: If only the C band is present, the absence of any burgundy color in the both T bands (IgG and IgM) indicates that no anti-COVID-19 antibodies are detected in the specimen. The result is negative.

IgM Positive: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive.

IgG Positive: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID-19 in the specimen. The result is IgG anti-COVID-19 positive.

IgG and IgM Positive: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive.

Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Additional information

Weight .5 lbs
Dimensions 8 × 5 × 3 in