Product Description

Medical HAV-IGM rapid Test Device

size: 2.5mm,3mm,3.5mm,4.0mm(strip)/3.0mm,4.0mm(cassette)

Intended Use:

The OnSite HAV IgM Rapid Test is a lateral flow chromatographic immunoassay for thequalitative detection of IgM antibody to Hepatitis A virus (HAV) in human serum or plasma. It isintended to be used as a screening test and as an aid in the diagnosis of infection with HAV.Any reactive specimen with the OnSite HAV IgM Rapid Test must be confirmed with alternativetesting method(s) and clinical findings.

Procedure:

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 1 drop (about ****5 μL) of specimen into the sample well making sure that there are no air bubbles.
Then add 1 drop (about ****0 μL) of Sample Diluent immediately. (for whole blood only)

Step 5: Set up timer
Step 6: Results can be read in *5 minutes. Positive results can be visible in as short as 1 minute.

Don’t read result after *5 minutes. To avoid confusion, discard the test device after interpreting the result.

Interpretation of the results:

NEGATIVE RESULT: If only the C band is developed, the test indicates that no detectable IgM anti-HAV is present in the specimen. The result is negative.

POSITIVE RESULT: If both C and T bands are developed, the test indicates for the presence of IgM anti-HAV in the specimen. The result is positive.

INVALID: If no C band is developed, the assay is invalid regardless of color development on the T band as indicated below. Repeat the assay with a new device.