【SAMPLE COLLECTION AND STORAGE】
• The Dengue NS1 & IgG/IgM Rapid Test Combo 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】
1.Bring tests, specimens, buffer and/or controls to room temperature(15- 30°C) before use.
2.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.
NS1 Antigen:
Using the provided disposable pipette, transfer 2 drops of Serum or Plasma specimen into the center of the specimen well(s) of the test
cassette.
OR
Transfer 1 drop of Whole Blood specimen into the center of the specimen well(s) of the test cassette, then add 1 drop of buffer, and start the timer.
IgG/IgM Antibody:
Transfer 1 drop of sample into the center of the specimen well(s) of the test cassette, then add 1 drop of buffer, and start the timer.
3.Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
【TEST LIMITATIONS】
1. The Dengue NS1 & IgG/IgM Combo Test is for in vitro diagnostic use only. The test should be used for the detection of Dengue NS1
antigen and IgG, IgM antibody in whole blood, serum or plasma specimens only.
2. The Dengue NS1 & IgG/IgM Combo Test will only indicate the presence of Dengue NS1 antigen and IgG, IgM antobody in the
specimen and should not be used as the sole criteria for the diagnosis of Dengue.
3. In the early onset of fever, anti-Dengue IgM concentrations may be below detectable levels. For primary infection, an IgM antibody-capture enzyme-linked immunosorbent assay (MAC-ELISA) showed that 80% of the Dengue patients tested exhibited detectable levels of IgM antibody by the fifth day after infection, and 99% of the patients tested IgM positive by day 10.5 It is recommended that patients be tested within this time.
4. For the secondary infection, a low molar fraction of anti-Dengue IgM and a high molar fraction of IgG that is broadly reactive to flaviviruses characterize the antibodies. 5 The IgM signal may be faint and the cross reaction in the region of IgG line may appear.
5. Serological cross-reactivity across the flavivirus group (Dengue 1, 2, 3 & 4, St. Louis encephalitis, West Nile virus, Japanese
encephalitis and yellow fever viruses) is common.6,7,8 Positive results should be confirmed by other means.
6. The continued presence or absence of antibodies cannot be used to determine the success or failure of therapy.
For further operation or performance details, please refer to final instruction manual.
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