Enterovirus 71 (EV71)-IgM Detection Kit (Colloidal Gold Method)

Intend Use

Enterovirus 71 (EV71)-IgM Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay for the qualitative detection of IgM-class antibodies to human Enterovirus 71 (EV71) in serum, plasma or whole blood samples. It is intended to be used as a screening test and provides a preliminary test result for early diagnosis and management of patients related to infection with EV71.

Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be combined to confirm the test result obtained by this device.

EV 71 is the latest virus found in the current enterovirus group. It is highly infectious and has a high morbidity rate, especially with neurological complications. Humans are the only known natural host of EV71, and EV71 is mainly transmitted through fecal-oral infection. Because EV 71 is highly infectious to the central nervous system, hand-foot-mouth disease and herpetic angina are the most common, and the disease usually peaks in June or July. Humans are generally susceptible to EV71, while infants and young children are more at risk.

TEST PRINCIPLE

This kit adopts colloidal gold-immunochromatography assay (GICA).

The test card contains:

1. Colloidal gold-labeled antigen and quality control antibody complex.

2. Nitrocellulose membranes immobilized with one test line (T line) and one quality control line (C line).

When an appropriate amount of sample is added to the sample well of the test card, the sample will move forward along the test card under capillary action.

If the sample contains an IgM antibody of EV71, the antibody will bind to the colloidal gold-labeled EV71 antigen, and the immune complex will be captured by the monoclonal anti-human IgM antibody immobilized on the nitrocellulose membrane to form a purple/red T line , showing that the sample is positive for IgM antibody.

Materials Provided

Specification: 1T/box,20T/box,25T/box,50T/box

Test Procedure 

Step1: Allow the test device, buffer, specimen to equilibrate to room temperature (15-30℃) prior to testing.

Step2: Remove the test device from the sealed pouch. Place the test device on a clean, flat surface.

Step3: Label the device with specimen number.

Step4: Using a Disposable Dropper, transfer serum, plasma or whole blood. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, and immediately add 2 drops of test buffer (approximately 70-100μl). Make sure there are no air bubbles.

Step5: Set up a timer. Read the results in 15 minutes.

Do not interpret the result after 20 minutes. To avoid confusion, discard the test device after interpreting the result. If you need to store it for a long time, please take a photo of the result.

RESULTS

NEGATIVE:

If only the quality control line C appears, and the test lines T is not purple/red, it indicates that no antibody is detected, and the result is negative.

POSITIVE:

If both the quality control line C and the test line T appear purple/red, it indicates that the IgM antibody is detected, and the result is positive for IgM antibody.

INVALID:

If the quality control line C is not displayed, the test result is invalid regardless of whether there is a purple/red test line, and it should be tested again.