Dengue IgG IgM and NS1 Rapid Test

PocTell^® Dengue IgG IgM and NS1 Rapid Test Device is a lateral flow chromatographic immunoassay for the qualitative detection of dengue IgG/ IgM and virus antigen (Dengue Ag) in human whole blood, serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses. Any reactive specimen with the Dengue IgG/IgM/NS1 Combo Rapid Test Device must be confirmed with alternative testing method(s) and clinical findings.

PocTell^® Dengue IgG IgM and NS1 Rapid Test is a qualitative membrane-based immunoassay for the detection of Dengue antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in test line region 1 of the test. During testing, the specimen reacts with Dengue antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region 1. If the specimen contains IgG antibodies to Dengue, a colored line will appear in test line region 1. In the IgM component, anti-ligand is coated in test line region 2 of the test. During testing, the specimen reacts with ligand anti-human IgM. Dengue IgM antibodies, if present in the specimen, reacts with the ligand anti-human IgM and the Dengue antigen-coated particles in the test strip, and this complex is captured by the anti-ligand, forming a colored line in test line region 2.

Therefore, if the specimen contains Dengue IgG antibodies, a colored line will appear in test line region 1. If the specimen contains Dengue IgM antibodies, a colored line will appear in test line region 2. If the specimen does not contain Dengue antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always change appeared in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

PocTell^® Dengue NS1 Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing mouse anti-dengue NS1 antigen conjugated with colloid gold (Dengue Ab conjugates), 2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with rabbit anti-dengue NS1 antigen, and the C band is pre-coated with goat anti-mouse IgG antibody. The antibodies to dengue antigen recognize the antigens from all the four serotypes of the dengue virus.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the test cassette. Dengue NS1 Ag if present in the specimen will bind to the Dengue Ab conjugates. The immunocomplex is then captured on the membrane by the pre-coated rabbit anti-NS1 antibody, forming a burgundy colored T band, indicating a Dengue Ag positive test result. Absence of the T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti-mouse IgG/mouse IgG-gold conjugate regardless of the presence of colored T band. Otherwise, the test result is invalid and the specimen must be retested with another device.

Allow test device, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1.Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
2.Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
3.Step 3: Be sure to label the device with specimen's ID number.
4.Step 4: Fill the plastic dropper with the specimen. Holding the dropper vertically, dispense approximately 10 µL specimen. and 2~3 drops (approximately 80 µL-120µL) of buffer into the IgG/ IgM sample well and 5 drops of specimen(approximately 50 µL) and 1 drop (approximately 40µL) of buffer into the NS1 sample well, making sure that there are no air bubbles.
5.Step 5: Set up a timer.
6.Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute. Don't read results after 30 minutes.

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