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Intended Use

The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens.

Principle

The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Storage and Stability

1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.

2.The test must remain in the sealed pouch until use.

Additional Special Equipment

Materials Provided

ŸTest devices            Extraction Tube

ŸSterilized Swab          Buffer

ŸPackage Insert

Materials Required But Not Provided

ŸTimer

Precautions

1.For professional in vitro diagnostic use only. Do not use after expiration date.

2.Do not eat, drink or smoke in the area where the specimens and kits are handled.

3.Handle all specimens as if they contain infectious agents.

4.Observe established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

5.Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

6.Follow standard biosafety guidelines for handling and disposal of potential infective material.

7.Humidity and temperature can adversely affect results.

Specimen Collection

It is applicable to the diagnosis of the influenza virus A and B from the specimens of nasal swabs, throat swabs or nasal aspirates. Use freshly collected specimens for optimal test performance. Inadequate specimen collection or improper specimen handling may yield a false-negative result.

1.Nasal Swabbing ： Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several times to collect the epidermal cells of the mucus. It is recommended to collect specimen from nasal basin for more accurate results.

2.Throat Swabbing ： Deeply insert the sterilized swab into the throat and swab several times to collect the epidermal cells of the mucus. Caution has to be paid to avoid the swab to be contaminated with saliva.

3.Specimen collected may be stored for 1 days at 2-8℃ if not tested within 1 hours. For long term storage, specimens should be kept below -20℃.

Specimen Preparation

1.Add 0.5 ml of the specimen extraction buffer into the extraction tube, and put it on the tube stand.

2.Insert the swab into the extraction tube which contains 0.5 ml of the extraction buffer. Rotate the swab inside the tube using a circular motion to roll the side of the extraction tube so that the solution is expressed and reabsorbed from the swab. The extracted solution will be used as test specimen.