Rapid-VIDITEST. Influenza A

Transcription

1 Rapid-VIDITEST Influenza A (One step Influenza A Card test for the detection of Influenza type A antigen from human nasopharyngeal specimens (swab, nasopharyngeal wash and aspirate). Instruction manual Producer: VIDIA spol. s r.o., Nad Safinou II 365,Vestec, Jesenice, Czech Republic, Tel.: , INTENDED USE: The Rapid-VIDITEST Influenza A test is a one step coloured chromatographic immunoassay for the qualitative detection of influenza type A antigen in human nasopharyngeal specimens to aid in the diagnosis of Influenza infection. Only for laboratory use. INTRODUCTION: Influenza is caused by a virus that attacks mainly the upper respiratory tract the nose, throat and bronchi and rarely also the lungs. The infection usually lasts for about a week. It is characterized by sudden onset of high fever, myalgia, headache and severe malaise, non-productive cough, sore throat, and rhinitis. Most people recover within one to two weeks without requiring any medical treatment. In the very young, the elderly and people suffering from medical conditions such as lung diseases, diabetes, cancer, kidney or heart problems, influenza poses a serious risk. In these people, the infection may lead to severe complications of underlying diseases, pneumonia and death. The currently circulating influenza viruses that cause human disease are divided into two groups: A and B. Influenza A has 2 subtypes which are important for humans: A(H3N2) and A(H1N1), of which the former is currently associated with most deaths. Influenza viruses are defined by 2 different protein components, known as antigens, on the surface of the virus. They are spike-like features called haemagglutinin (H) and neuraminidase (N) components. Outbreaks and sporadic human infection with swine influenza or avian influenza have been occasionally reported. PRINCIPLE OF THE TEST: The Rapid-VIDITEST Influenza A is a qualitative immunochromatographic assay for the determination of Influenza type A antigens. The membrane is pre-coated with mouse monoclonal antibodies, on the test band region, to recognize these antigens. During testing, the sample is allowed to react with the coloured conjugate (anti-type A mouse monoclonal antibodies-red microspheres) which was pre-dried on the test. The mixture then moves upward on the membrane by capillary action. As the sample flows through the test membrane, the coloured particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the coloured particles. Different coloured lines will be visible, depending upon the type of antigens contents of the sample. These lines are used to interpret the result. 1

2 The mixture continues to move across the membrane to the immobilized antibody placed in the control band region, a GREEN coloured band always appears. The presence of this GREEN band serves as 1) verification that sufficient volume is added, 2) that proper flow is obtained and 3) as an internal control for the reagents. MATERIALS PROVIDED: - Card tests contained plastic pipettes - Diluent B (Sample Diluent) - Testing tubes - Sterile swabs - Disposable pipettes - Instructions for use MATERIALS REQUIRED BUT NO PROVIDED: - Disposable gloves - Timer - Specimen collection container SPECIMEN COLLECTION AND PREPARATION: Nasopharyngeal swab method: - Bend shaft to follow curve of nasopharynx. - Insert swab through nostril to posterior nasopharynx. - Rotate swab a few times to obtain infected cells. - For an optimal sample, repeat procedure using other nostril. Nasopharyngeal aspirate method (suction apparatus, sterile suction catheter): - Instill several drops of solution saline into each nostril. - Place catheter through nostril to posterior nasopharynx. - Apply gentle suction. Using rotating motion, slowly withdraw catheter. - For an optimal sample, repeat procedure using other nostril. Send specimen to lab immediately (testing sensitivity decrease over time). Cool specimen to 2-4 C (36-40 F) during storage and transport. PROCEDURES: Allow the tests, samples and diluent to reach to room temperature (15-30ºC/59-86ºF) prior to testing. Do not open pouches until ready to perform the assay. To process the collected nasopharyngeal wash or aspirate samples: Use a separate pipette and testing tube for each sample. 1. Add the nasopharyngeal wash or aspirate sample (6 drops or 300uL) in a testing tube or vial (1). 2. Add the diluent B (3 drops or 150uL) and mix (2). Remove the Rapid-VIDITEST Influenza A from its sealed pouch and use it as soon as possible. Use a separate device for each sample. 2

3 3. Dispense exactly 100 ul into the specimen well (S) (3). Start the timer. Read the result at 10 minutes after dispensing the sample. To process the collected nasopharyngeal swab: Use a separate testing tube or vial for each sample (swab). 1. Add the diluent B (15 drops or 500uL) into the testing tube or vial (1). 2. Put the nasopharyngeal swab, mix and extract as much liquid possible from the swab (2). Remove the Rapid-VIDITEST Influenza A from its sealed pouch and use it as soon as possible. Use a separate device for each sample. 3. Dispense exactly 100 ul into the specimen well (S). Start the timer. Read the result at 10 minutes after dispensing the sample. 3

4 INTERPRETATION OF RESULTS : GREEN RED RED Negative Positive Invalid Invalid POSITIVE: Two lines appears across the central window, in the result line region (red test line marked with the letter T) and in the control line region (green control line marked with the letter C). NEGATIVE: Only one green band appears across the control line region marked with the letter C (control line). INVALID: A total absence of the green control coloured band regardless the appearance or not of the red test line. Note: Insufficient specimen volume, incorrect procedural techniques or deterioration of the reagents 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 and contact your local distributor. NOTES ON THE INTERPREATION OF RESULTS: The intensity of the red coloured band in the result line region (T) will vary depending on the concentration of antigens present in the specimen. However, neither the quantitative value, nor the rate of increase in antigens can be determined by this qualitative test. QUALITY CONTROL: Internal procedural controls are included in the test. A green line appearing in the control region (C) is the internal procedural control. It confirms sufficient specimen volume and correct procedural technique. 4

5 LIMITATIONS: 1. The test must be carried out within 2 hours of opening the sealed pack. 2. This test provides a presumptive diagnosis for Influenza A infections. A confirmed infection diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated. 3. A negative result may be obtained if the specimen is inadequate or antigen concentration is below the sensitivity of the test. Therefore, it is recommended that all negative Rapid-VIDITEST Influenza A test results undergo confirmatory testing using other method and/or by cell culture. EXPECTED VALUES: Influenza types A viruses cause epidemics of disease almost every winter. In the United States, these winter influenza epidemics can cause illness in 10% to 20% of people and are associated with an average of 36,000 deaths and more than 200,000 hospitalizations per year. PERFORMANCE: Sensitivity and specificity: Different virus extract dilutions were tested directly in the sample diluent or spiked in a negative nasal specimen in accordance with the kit instructions. The detection of Influenza type A with Rapid-VIDITEST Influenza A showed >99% of sensitivity compared with another commercial rapid test and showed >99% of specificity compared with the commercial rapid test. Cross-Reactivity It was performed an evaluation to determine the cross reactivity of Rapid-VIDITEST Influenza A. There is not cross reactivity with common respiratory pathogens, other organisms and substances occasionally present in nasopharyngeal samples: Respiratory syncytial virus, Adenovirus. STORAGE AND STABILITY: Store as packaged in the sealed pouch either at refrigerated or room temperature (2-30ºC/36-86ºF). The test is stable through the expiration date printed on the sealed pouch. Do not freeze. PRECAUTIONS: - For professional in vitro diagnostic use only. - Do not use after expiration date. - The test should remain in the sealed pouch until use. - Do not use the test if pouch is damaged. - Follow Good Laboratory Practices, wear protective clothing, use disposal gloves, do not eat, drink or smoke in the area. - All the specimens should be considered potentially hazardous and handled in the same manner as an infectious agent. - The test should be discarded in a proper biohazard container after testing. - The test must be carried out within 2 hours of opening the sealed bag. 5

6 REFERENCES 1. Daniel E. Noyola, et al. Comparison of a New Neuraminidase Detection Assay with an Enzyme Immunoassay, Immunofluorescence, and Culture for Rapid Detection of Influenza A and B Viruses in Nasal Wash Specimens. Journal of Clinical Microbiology, Mar. 2000, p Vol. 38, No Newman A.P. et al. Human Case of Swine Influenza A (H1N1) Triple Reassortant Virus Infection, Wisconsin. Emerging Infectious Diseases, Sept 2008, Vol 14, No. 9, pp Andreea C. Cazacu, Gail J. Demmler et al. Comparison of a New Lateral-Flow Chromatographic Membrane Immunoassay to Viral Culture for Rapid Detection and Differentiation of Influenza A and B Viruses in Respiratory Specimens. Journal of Clinical Microbiology, Aug. 2004, p Vol. 42, No Kenneth E. Irmen and James J. Kelleher. Use of Monoclonal Antibodies for Rapid Diagnosis of Respiratory Viruses in a Community Hospital. Clinical and Diagnostic Laboratory Immunology, May 2000, p Vol. 7, No. 3. SYMBOLS FOR IVD COMPONENTS AND REAGENTS In vitro diagnostic device Use by Batch code Manufacturer Last Revision: January