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ACCU-TELL RAPID INFLUENZA A TEST
Declaration: As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Catalog No. Product Name ABT-IDT-B89 Flu A Cassette
Accu-Tell ® Rapid Influenza A Test is a colloidal gold enhanced, rapid immunoassay for the qualitative detection of influenza A viral nucleoprotein antigens.
The test is a two sites sandwich immunoassay. If influenza A viral antigens is present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second light pink to purple line will appear in the test line region indicating an A positive result.
1. Store test sticks and extraction buffer tightly capped at room temperature (15°-30°C). 2. Do not freeze any of the test kit components. 3. Do not use test sticks and reagents after expiration date. 4. Recap the desiccated container immediately after removing a test stick. 5. Test sticks that have been outside of the desiccated container for more than 1 hour should be discarded. 1. For in vitro diagnostic use only.
2. Follow your clinical and/or laboratory safety guidelines in the collection, handling, storage and disposal of patient specimens and all items exposed to patient specimens.
3. Swabs, tubes and test sticks are for single use only.
4. The extraction buffer contains a solution with a preservative (0.09% sodium azide). If solution comes in contact with the skin or eyes, flush with ample volumes of water.
5. Solutions that contain sodium azide may react explosively with lead or copper plumbing. Use large quantities of water to flush discarded solutions down a sink.
6. Do not interchange or mix components from different kit lots.
7. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
1. Only nasal swabs can be used with this test. Use of nasal washes or aspirates has not been validated.
2. Insert the swab into the nostril that appears to have the most secretion. Using a gentle rotation, push the swab until resistance is met at the level of the turbinates (at least one inch into the nostril). Rotate the swab a few times against the nasal wall.
3. Use only the swabs supplied in the Flu A Rapid Test kit. Swabs from other suppliers have not been validated. Do not use swabs that have cotton, rayon or polyester tips or wooden shafts.
4. Test the swab as soon as possible after collecting the specimen. If swabs cannot be processed immediately, specimens may be held at room temperature for no longer than 8 hours. Swabs may also be stored at 2°-8°C for up to 24 hours. Extracted samples may be held at room temperature or refrigerated (2°-8°C) for up to 24 hours.
5. To transport patient samples place swab in a clean, dry container such as a plastic or glass tube.
6. If a culture result is desired, a separate swab must be collected for the culture.
7. The test performance depends on the quality of the sample obtained as well as the handling and transport of the sample. Negative results can occur from inadequate specimen collection and/or handling. Training in specimen collection is recommended because of the importance of specimen quality.
STEP 1: MIX SWAB IN BUFFER
Put the specimen swab into the tube with 0.3 mL of Extraction Buffer. Vigorously mix the solution by rotating the swab forcefully against the side of the tube at least ten times (while submerged). Best results are obtained when the specimen is vigorously mixed in the solution.
STEP 2: SQUEEZE LIQUID FROM SWAB
Squeeze out as much liquid as possible from the swab by pinching the side of the flexible test tube as the swab is removed. Discard the swab in a suitable biohazardous waste container.
STEP 3: ADD SPECIMEN
Remove the test card from the foil pouch and place on a clean dry surface. Dispense 3 drops (100μl) of the specimen into the circular sample well on the card.
STEP 4: READ RESULTS
Interpret the test results at 15 minutes. Do not interpret the results after 30 minutes.
Discard used test tubes and test in suitable biohazardous waste container.
1. Negative: Only one purplish red colored band appears on the control region.
2. Positive: In addition to the control band, a distinct colored band also appears on the test region.
3. Invalid: Neither purplish red test band nor purplish red control band appears. The specimen should be tested again using a new device.
A clinical trial was conducted during the 2005-2006 flu season in China at 20 sites located in the east, central and west regions to establish the clinical sensitivity and clinical specificity of the Flu A Rapid Test in detecting influenza A antigens in nasal swab specimens. Sites included family practice and pediatric offices, emergency departments and clinics. All clinical samples were collected from patients with flu-like symptoms including fever, dry cough and myalgia. Nasal swab specimens were collected from a total of 455 subjects enrolled in the study. Of the 455 samples, 177 samples were from pediatric subjects (2-19 years) and 278 samples were from adults (> 20 years). The Flu A Rapid Test was compared to cell culture to determine the comparative clinical sensitivity and clinical specificity for detection of influenza A in nasal swab specimens.
COMPARISON OF FLU A RAPID TEST TO CELL CULTURE: NASAL SWAB
Flu A
Clinical Sensitivity: 75.8% (91/120)
(95% CI 64.4% – 81.9%)
Clinical Specificity: 97.0% (324/334)
(95% CI 93.4% – 98.2%)
Assay Reproducibility
A reproducibility proficiency study was conducted to demonstrate that the Flu A Rapid Test would perform acceptably in the hands of nurses, nurse practitioners and physicians’ office personnel. A panel of swabs including negative (no virus), strong negative (below the limit of detection), low (near the limit of detection) and mid viral levels for influenza A were coded and masked to the operators. This study was conducted with three operators at three health centers in the eastern China (2 physician’s offices and 1 clinic site). Two invalid tests were considered as incorrect results in each analysis.
invalids due to insufficient volume or no control line
Analytical Sensitivity
Dilutions of influenza A/Kitakyushyu/159/93 (H3N2) was run in triplicate on three lots of the Flu A Rapid Test. The approximate detection limits of the Flu A Rapid Test are 4.4 x 104 TCID50/test for influenza A.
Analytical Specificity and Cross-reactivity
The Flu A Rapid Test was evaluated with 44 bacterial and viral isolates. Cross-reactivity testing was performed with materials obtained from ATCC. Bacterial isolates were tested at a concentration of approximately >108 cfu/mL. Very high levels of Staphylococcus aureus (>9×108 cfu/mL) produced a positive result for influenza A. All other bacteria listed gave negative responses. Viral isolates were tested at approximately 1.4×105 – 2.3×108 TCID50/test. All viruses listed produced negative responses.
Bacterial Panel:
Acinetobacter calcoaceticus Bordetella pertussis
Candida albicans Corynebacterium diphteriae
Enterococcus faecalis Enterococcus gallinarum
Escherichia coli Haemophilus influenza
Klebsiella pneumoniae Legionella pneumophilia
Moraxella catarrhalis Mycobacterium avium
Mycobacterium tuberculosis Neisseria meningitidis
Proteus mirabilis Proteus vulgaris
Pseudomonas aeruginosa Serratia marcescens
Staphylococcus aureus Staphylococcus epidermidis
Streptococcus Group A Streptococcus Group B
Streptococcus mutans Streptococcus pneumoniae
Torulopsis glabrata
Viral Panel
Adenovirus Type 1 Adenovirus Type 2
Adenovirus Type 3 Adenovirus Type 6
Coxsackievirus B2 Coxsackievirus B3
Coxsackievirus B4 Coxsackievirus B5
Echovirus 6 Echovirus 11 (Gregory)
Echovirus 30Measles Mumps (Enders strain)
Parainfluenza Type 1 Parainfluenza Type 3
Parainfluenza Type 4B Rhinovirus 3
Rhinovirus 7 RSV (Long strain)
Influenza A Panel testing
A total of 46 human and animal influenza strains were tested with the Flu A Rapid test. Viral titers (TCID50) for A/Kitakyushu/159/93 (H3N2) were determined by inoculating MDCK cells, followed by standard procedures for cell culture viral assays. Aliquots of these controls with known TCID50 were then used to establish a standard curve in an ELISA assay. The concentrations of other influenza viruses were determined indirectly using the ELISA assay after the viruses had been inactivated.
Although this test has been shown to detect cultured avian influenza viruses, including avian influenza A subtype H5N1 virus, the performance characteristics of this test with specimens from humans infected with H5N1 or other avian influenza viruses are unknown.
The following potential interferents were tested and were found to have no affect on the performance of the Flu A Rapid Test.
Potential Interferent Concentration
Acetyl Salicylic Acid 20 mg/mL
Acetamidophenol 10 mg/mL
Chlorpheniramine maleate 5 mg/mL
Dextromethorphan HBr 20 mg/mL
Diphenhydramine HCl 5 mg/mL
Ephedrine HCl 20 mg/mL
Guiacol Glyceryl Ether 20 mg/mL
Oxymetazoline HCl 10 mg/mL
Phenylephrine HCl 100 mg/mL
Phenylpropanolamine 20 mg/mL
Whole Blood 2%
OTC Throat Drops
Throat Drop (Halls) 25%
Throat Drop (Zinc) 25%
Throat Drop (Ricola) 25%
OTC Nasal Sprays
Nasal Spray (Zicam) 10%
Nasal Spray (Afrin) 10%
Nasal Spray (Vicks Sinex) 10%
Note: A very high hemoglobin concentration could interfere with the interpretation of the test result.
1. FDA, Center For Devices and Radiological Health, Guidance for Industry and FDA Staff- In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path, April 2006.
2. Cheung M, Lieberman JM. Influenza: update on strategies for management. Contemporary Pediatrics. October 2002;19:82.
3. Montalto N, Byrd R. An Office-Based Approach to Influenza: Clinical Diagnosis and Laboratory Testing. American Family Physician. January 2003;67:111-118.
4. CDC, Biosafety in Microbiological and Biomedical Laboratories, 2nd Ed., HHS Publication No. 8808395, 4-6, 1988.
5. Lee D, Rosenfeld R, Adenoid bacteriology and sinonasal symptoms in children. Otolaryngology – Head and Neck Surgery. March 1997;116:301-307.
6. WHO recommendations on the use of rapid testing for influenza diagnosis, July 2005, available at http://www.who.int/csr/disease/avian_influenza/guidelines/RapidTestInfluenza_web.pdf
7. CDC, MMWR-Update: Influenza Activity United States, 2004-05 Season, March 4, 2005 / 54(08);193-196.
The above information is just for reference. The actual technical specifications are subject to the insert provided with the product. |
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