【SAMPLE COLLECTION AND STORAGE】
• 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 specimens. Whole 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.
【PRECAUTIONS】
• For professional in vitro diagnostic use only.
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious
agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Buffered Saline contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of buffered saline or extracted samples, always flush with copious quantities of water to prevent azide build up.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• The used testing materials should be discarded in accordance with local, state and/or federal regulations.
【OPERATION】
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 trapping 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.
【RESULTS INTERPRETER】
Note:
1. A negative result can occur if the quantity of Salmonella typhi specific antibodies present in the specimen is below the detection limits of the assay, or the antigens that are detected are not present during the stage of disease in which a sample is collected.
2. A negative test result cannot exclude a recent infection.
3. The presence of detectable Salmonella typhi specific antibodies may mean positive for Typhoid fever. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.
【DETAILED PICTURE】
For further operation or performance details, please refer to final instruction manual.
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