RVR Dengue Combo NS1 & IgG/IgM Rapid Test

No. Do not use the test device if the pouch is damaged or the seal is broken/ incomplete. Please use a new test.

No. Desiccant should come together with test device in the pouch. Please use a new test.

No. User should not use the test beyond the expiry date shown on the test kit labelling.

No. Refrigerated specimen should be equilibrated to room temperature (about 30 minutes) or between 15°C and 30°C before being tested. Remember to mix the specimen before use.

Mix the specimen by gently inverting the tube 5-10 times. DO NOT vortex the specimen. Specimens containing visible particulate matter should be clarified by centrifugation before testing.

No. Haemolyzed specimen cannot be used on this test. Haemolyzed samples may interfere with test results.

Yes. Whole blood sample from finger prick can be used. However, skilful professional user and a suitable lancet are required to ensure sufficient specimen can be collected. It is highly recommended to use whole blood sample from venipuncture.

Pinching the top with fingers and position the capillary tube into the specimen. Subsequently, lift the finger from the capillary tube slowly and fill the capillary tube with specimen. Make sure not to exceed the specimen line marked on the capillary tube. Then, hold the capillary tube vertically and pinch the top of capillary tube to dispense the entire specimen into the sample well (marked “S”).

For video demo, please visit https://www.youtube.com/watch?v=kocxQLfMP8g

Pinching the bulb at the top with fingers and position the dropper into the specimen. Subsequently, lift the fingers slowly from the bulb to fill the dropper with the specimen. Then, hold the dropper vertically and pinch the bulb of the dropper to dispense 1 drop of serum/plasma, or 2 drops of whole blood (drop by drop) into the sample well (marked “S”). Make sure there are no air bubbles.

For video demo, please visit https://www.youtube.com/watch?v=kocxQLfMP8g

No. Sample volume needed for Dengue IgG/IgM and NS1 Ag tests are different. User should use the capillary tube provided for Dengue IgG/IgM test and dropper for Dengue NS1 Ag test, as stated in the IFU.

Yes. The 2 buffer bottles provided in the kit are identical. Both Dengue IgG/IgM and NS1 Ag tests are using the same buffer. You may use either one of the buffers in the kit.

No. Buffer from other brand or other test kit cannot be used as a substitute for the buffer in this kit. Please contact your supplier for assistance. The buffers provided in the kit are more than the actual volume needed to complete all 25 tests in a kit. User should check the IFU again and ensure that the tests are run following the correct assay procedure.

No. User should follow the instruction of the assay procedure strictly. Failure to follow the instruction may give inaccurate test results. Repeat the test if the sample volume is incorrect during the testing.

Specimen must be added to well “S” while buffer at well “B”. If you did it wrongly, discard the test and repeat with a new test device. The tests should be run as per instructions stated in the IFU.

It may be due to insufficient specimen or buffer volume. Sufficient amount of specimen and buffer are important to ensure the sample to flow up properly. Please repeat the test with a new test device if invalid results observed.

User should read the assay procedure in the IFU provided carefully before running the test. User should ensure that the correct volume of specimen is used during the testing.

• If using a micropipette, make sure 5 μl of specimen for IgG/IgM test, 60 μl of serum/plasma or 70 μl of whole blood for NS1 test are used.
• If using capillary tube for IgG/IgM test, make sure sample taken until the specimen line and dispense entire specimen into the well “S”
• If using dropper for NS1 Ag test, make sure 2 full drops of serum/plasma or 2 full drops of whole blood is dispensed into the well “S”
• For whole blood specimen, the sample pad area at well “S” will be fully covered with blood sample if the correct amount of specimen is added

When adding buffer, it is important to hold the buffer bottle vertically, carefully press the bottle to release full drop of buffer, one drop by one drop. The droplet volume of the buffer may be inconsistent if the buffer bottle is not hold vertically above the well “S”, or buffer being release too fast.

In rare cases, sample flow problem may also occur if too much specimen or buffer were added into well “S” or well “B”. Excessive sample may block the well and inhibit the sample flow to the sample pad.

No. The assay procedures need to be followed strictly. If no sample flow observed, check again the procedure and repeat the test with a new test device

Only positive results can be read before 20 minutes. Positive results that appear before 20 minutes can be considered as positive. Negative result must be confirmed at 20 minutes.

No. Do not read results after 25 minutes. Results read after 25 minutes may lead to a false positive, false negative, or invalid result.

If coloured bands appear at the control line (C) and test lines (T, IgG, and/or IgM), it indicates a positive result. Positive results indicate the presence of Dengue NS1 antigen and Dengue antibodies in the specimen. Positive result should not be used as the sole criteria for the diagnosis of Dengue. Positives results should be confirmed by alternative testing method and clinical finding before positive determination is made.

If only control line (C) is visible, no coloured line developed at positions T, IgG or IgM. No IgG or IgM antibodies or NS1 antigen were detected. Negative result does not preclude the possibility of exposure to or infection with dengue viruses. Negative result can occur if the quantity of dengue NS1 antigen or antibody present in specimen is below the detection limit of the test, or the dengue antigen that are detected are not present during the stage of disease in which sample is collected.

If the symptom persists, while the result is negative or non-reactive result, it is recommended to re-sample the patient few days later or test with an alternative testing method such as PCR, ELISA.

Yes. The test kit can be stored at a temperature between 2-30 °C. Do not freeze the kit or its components and do not store the kit under direct sunlight.

When stored in a refrigerator, all kit components must be equilibrated to room temperature (15-30 °C) or a minimum of 30 minutes prior to performing the test.

Users should follow respective Good Laboratory Practice SOP of the labs. However, it is recommended to use external controls, positive and negative, to confirm the test procedure and to verify proper test performance, particularly under the following circumstances:

• New operator uses the kit, prior to performing testing of specimens.
• A new lot of test kits is used.
• A new shipment of test kits is used.
• The temperature used during storage of the kit falls outside of 2-30°C.
• The temperature of the test area falls outside of 15-30°C.
• To verify a higher-than-expected frequency of positive or negative results.
• To investigate the cause of repeated invalid results.