Dengue NS1 Antigen Rapid Test
The Dengue NS1 Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consistsof: 1) a burgundy colored conjugate pad containing mouse anti-dengue NS1 antigen conjugated withcolloid gold (Dengue Ab conjugates) and chicken IgY conjugated with colloidal gold,2) a nitrocellulosemembrane strip containing a test band (T band) and a control band (C band). The T band is pre-coatedwith mouse anti-dengue NS1 antigen, and the C band is pre-coated with goat anti-chicken IgY 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 specimenwill bind to the Dengue Ab conjugates.
The immunocomplex is then captured on the membrane by the pre-coated mouse anti-NS1 antibody,forming a burgundy colored T band, indicating a Dengue Ag positive test result.Absence of the T bandsuggests a negative result. The test contains an internal control (C band)which should exhibit a burgundycolored band of the immunocomplex of goat anti-chicken lgYIchicken IgY-gold conjugate regardless of thepresence of colored T band. Otherwise, the test result is invalid and the specimen must be retested withanother device.
A total of 305 patient samples from susceptible subjects were tested by the Dengue NS1 Rapid Testand by a commercial EIA.
Comparison for all subjects is showed in the following table:
| Dengue NS1 Rapid Test | |||
| Dengue Ag EIA Test | Positive | Negative | Total |
| Positive | 128 | 2 | 130 |
| Negative | 1 | 174 | 175 |
| Total | 129 | 176 | 305 |
| Relative Sensitivity | 98.46%,95% CI:94.56%`99.58% | ||
| Relative Specificity | 99.43%,95%CI:96.83%-99.90% | ||
| Overall Agreement | 99.02%,95%CI:97.15%-99.66% | ||
when ready to test, open the pouchat the notch and remove device.Placethe test device on a clean,flat surface.
For whole blood / Plasma / Serum samples: Fill the dropperwith the specimen then add 1 drop (about 30-45 uL)of specimen and 1-2 drops (about 35-50 uL/drop) of buffer intosample well, making sure that there are no air bubbles.
Results can be read in 15 minutes.
Don't read results after 30 minutes.
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