Accu-Tell^® Influenza A+B Cassette (Swab/Nasal Aspirate)

Product Description

CATALOG

KEY POINTS

Detection for: Influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens;

Reading time: 8 minutes;

Relative Sensitivity: Type A: 87.2%; Type B: 92.5%;

Relative Specificity: Type A: 94.5%; Type B: 97.5%;

Accuracy: Type A: 92.8%; Type B: 96.7%.

INTRODUCTION

Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract .It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus.1 Influenza outbreaks occur each year during the fall and winter months. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder.

INTENDED USE

ACCU-TELL^® Influenza A+B Cassette (Swab/Nasal Aspirate) is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab or throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

SPECIMEN COLLECTION AND PREPARATION

Nasal swab sample

Insert a sterilized swab into a nasal cavity securely from a nostril and collect muco-epidermis wiping turbinate several times.

Pharyngeal swab sample

Insert a sterilized swab into pharynx and collect muco-eoidermis mainly wiping flare region of post-pharyngeal wall and palatine tonsil several times, and be careful not to make saliva attach to the swab.

Nasopharyngeal aspirate

Connect an aspiration catheter to an aspiration trap that is attached to an aspiration device, insert the catheter to nasal cavity from a nostril, start the aspiration device and then collect nasal aspirate sample. Dip a sterilized swab into the collected nasal aspirate sample and make the specimen cling to the swab.

TEST PROCEDURE

For Cassette:

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch.

2. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 8 drops of solution (Approx. 0.3mL) to the Extraction Tube. See illustration 1.

3. Place the swab specimen in the Extraction Tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 2.

4. Remove the swab while squeezing the swab head against the inside of the Extraction Tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 3.

5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4.

6. Add three drops of the solution (approx.80ul) to the sample well and then start the timer. Read the result at 8 minutes. Do not interpret the result after 15 minutes.

PERFORMANCE CHARACTERISTICS

Sensitivity, Specificity and Accuracy

ACCU-TELL^® Influenza A+B Cassette (Swab/Nasal Aspirate) has been evaluated with specimens obtained from the patients. RT-PCR is used as the reference method for ACCU-TELL^® Influenza A+B Cassette (Swab/Nasal Aspirate) Specimens were considered positive if Cell Culture indicated a positive result.

Reactivity with Human Influenza Strain

Influenza A strains

Subtype of H1N1: Mal/302/54, New Jersey/8/76, NWS/33, WS/33; H3N2: Aichi/2/68, Hong Kong/8/68, Port Chalmers/1/73 all are positive.

Influenza B strains

Russia/69, Hong Kong/5/72, Lee/40, Brigit, R5 all are positive.

Specificity Testing with Various Viral Strains

Virus other than influenza

No cross reaction with following pathogens:

Adenovirus, Coxsackie virus, Cytomegalovirus, Parainfluenza Virus Type1,2,3,4a, Enterovirus, Mumps virus, Respiratory syncytial virus, Rhinovirus.

Bacteria

No cross reaction with following bacteria:

Bordetella pertussis, Haemophilusparainfluenzae, Staphylococcus aureus, Streptococcus agalactiae, Neisseria meningitides, Streptococcus sp. group A, B, C.

LIMITATIONS

1. ACCU-TELL^® Influenza A+B Cassette (Swab/Nasal Aspirate) is for professional in vitro diagnostic use only. The test should be used for the detection of Influenza A and/or B virus in nasal swab, throat swab or nasal aspirate specimens. Neither the quantitative value nor the rate of increase in Influenza A and/or B virus concentration can be determined by this qualitative test.

2. ACCU-TELL^® Influenza A+B Cassette (Swab/Nasal Aspirate) will only indicate the presence of Influenza A and/or B virus in the specimen from both viable and non-viable Influenza A and B strains.

3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4. A negative result obtained from this kit should be confirmed by culture. A negative result may be obtained if the concentration of the Influenza A and/or B virus present in the nasal swab is not adequate or is below the detectable level of the test.

5. Excess blood or mucus on the swab specimen may interfere with test performance and may yield a false positive result.

6. The accuracy of the test depends on the quality of the swab sample. False negatives may result from improper sample collection or storage.

7. The use of over-the-counter and prescription nasal sprays at high concentrations can interfere with results, leading to either invalid or incorrect test results.

8. A positive result for influenza A and/or B does not preclude an underlying co-infection with another pathogen, therefore the possibility of an underlying bacterial infection should be considered.

9. Performance of the test has not been established for monitoring antiviral treatment of influenza.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.