One Step Norovirus Rapid Test, Feces specimen,gold colloidal method,Detection Norovirus antigen, high accuracy

Accessories:

Intended Use:

The Norovirus Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Norovirus in human feces specimens to aid in the diagnosis of Norovirus infection.

Test Principle:

The Norovirus Test Cassette (Feces) is a qualitative, lateral flow immunoassay for the detection of Norovirus in human feces specimens.

The assay uses Genogroup 1 and Genogroup 2 specific monoclonal antibodies coated on the test membrane. During testing, the stool specimen reacts with the conjugate antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with Genogroup 1 and 2 antibodies on the membrane and generates a colored line at the level of the T1 and T2 zone respectively. The presence of a colored line in T1 region indicates a positive result for Genogroup 1 and in T2 region for Genogroup 2 respectively, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control reaction zone (C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Specimen collection and pre-treatment:

1) Use clean, dry containers for specimen collection. Best results will be obtained if the assay is performed within 6 hours after collection.

2) For solid specimens: Unscrew and remove the dilution tube applicator. Becareful not to spill or spatter solution from the tube. Collect specimens by inserting the applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of feces (equivalent to 1/4 of a pea).

For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 80 µL) into the specimen collection tube containing the extraction buffer.

3) Replace the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

2. Testing

1) Remove the test from its sealed pouch, and place it on a clean, level surface. Label the test with patient or control identification. For best results, the assay should be performed within one hour.

2) Using a piece of tissue paper, break the tip of the dilution tube. Hold the tube vertically and dispense 3 drops of solution into the specimen well (S) of the test device.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.

As the test begins to work, color will migrate across the membrane.

3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

Note: If the specimen does not migrate due to the presence of particles, centrifuge the extracted specimens contained in the extraction buffer vial. Collect 100 µL of supernatant, dispense into the specimen well (S) of a new test device and start again, following the instructions described above.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of TP antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERS:

Sensitivity, Specificity and Accuracy

The performance of the Norovirus Rapid Test Cassette has been evaluated with 70 clinical specimens collected from children and young adults in comparison with RT-PCR method. The results show that the relative sensitivity of the Norovirus Rapid Test Cassette (Feces) is 95.65% and the relative specificity is 91.67%.

One Step Norovirus Rapid Test Cassette vs. RT-PCR

Relative Sensitivity: 95.65% (95%CI:*85.16%-99.57%)

Relative Specificity: 91.67% (95%CI:*73.00%-98.97%)

Relative Accuracy: 94.29% (95%CI:*86.01%-98.42%) *Confidence Intervals