Influenza A Antigen Rapid Test

INTENDED USE

The Influenza A Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Influenza A antigen in human nasopharyngeal swab, or oropharyngeal swab specimen in individuals who are suspected of respiratory viral infection consistent with flu symptoms.

MATERIALS

Materials Provided

• Foil pouches, each contains one test cassette, and one desiccant bag
• Assay buffer tubes (0.5ml each)with tips
• Disposable SamplingSwabs
• Paper tube holder
• Instruction for use

Materials Required But Not Provided

• Timer

TEST PROCEDURE

Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS

1. Sensitivity, Specificity and Accuracy

The Influenza A Antigen Rapid Test has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

Relative Sensitivity: 93.75% (95%CI: 89.04%～96.59%)  

Relative Specificity: >99.99% (95%CI：98.78%～100.00%) 

Accuracy: 98.01% (95%CI：96.42%～98.93%)