【INTENDEDUSE】
Typhoid fever Rapid Test is an immunochromatographic assay designed for the qualitative detection of specific IgG and IgM andodies against a specific Salmonella typhi antigen in human serum, plasma or whole blood. It is intended to be used as in vitro diagnostic of typhoid fever. The results obtained should not be the sole determinant for clinical decision
【INTRODUCTION】
Typhoidfever is an infectious disease caused by a bacterium, Salmonella typhi. It continues to be a major health problem especially in theAsia Pacific region, the Indian subcontinent, CentralAsia,Africa and South America. Definitive clinical diagnosis of typhoid is unreliable because typhoid fever symptoms mimic otherdiseases with fever that are commoninthispartoftheworld. Clinical presentations vary tremendously among patients andcover a widespectrum, hence theneed for a goodlaboratory test. In additional, an accurate diagnosis of typhoid at an early stage is important not only foran aetiological diagnosis for the patient but also to identify individuals that might serve as a source of infection6. Thus all cases of fever should be tested for typhoid and a rapid laboratory tests will be required. Typhoid fever Rapid Test Device offers early and specific diagnosis of typhoid.
【PRINCIPLE】
The Typhoid Test Kit is a lateral flow chromatographic immunoassay. The test strip in the cassette consists of: 1) a burgundy colored conjugate pad containing recombinant H antigen and O antigen conjugated with colloidal gold (HO conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test lines (G and M lines) and a control line (C line). The M line is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi and paratyphi, the G line is pre-coated with reagents for the detection of IgG anti-S. typhi and paratyphi , and the C line is pre-coated with goat anti-rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. IgM/IgG antibodies, if present in the specimen, will bind to the HO conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM/IgG antibody forming a burgundy colored M/G line, indicating a S. typhi or paratyphi IgM/IgG positive test result.
【MAINCONTENTS】
• Rapid test cassette with desiccant.
• Disposable pipettes
• Buffer
• Package insert
【STORAGEANDSTABILITY】
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DONOTFREEZE.
【SAMPLECOLLECTION】
• Typhoid fever Rapid Test (Whole Blood/Serum/Plasma) is intended for use with human whole blood, serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below-20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not freeze whole blood specimensWhole blood collected by fingerstick should be tested immediately.
• Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
【DIRECTIONOFUSE】
Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma to the specimen well (S) of the cassette and add 1 drop of buffer to the sample well, then start the timer. Avoid trappiping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the membrane.
3. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.
【QUALITYCONTROL】
• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
【LIMITATIONS】
• This product is designed for use with human serum, plasma and whole blood only.
• The test is a qualitative assay and is not for quantitative determination of antibodies concentration levels. The intensity of the band does not have linear correlation with the antibody titer of the specimen.
• The results obtained should only be interpreted in conjunction with other diagnostic results and clinical information.
Your message must be between 20-3,000 characters!