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Dengue NS1 ELISA Test
Dengue NS1 ELISA Test

Catalog No.    Product Name

ABT-EIA- F35  Dengue NS1 ELISA Test

INTENDED USE

ACCU-TELL® DENV NS1 ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of dengue virus NS1 antigen in human serum or plasma specimens. It is intended for use in clinical laboratories for diagnosis and management of patients related to infection with dengue virus during the acute phase.


PERFORMANCE CHARACTERISTICS


1. A total of 55 sera from patients confirmed of having dengue virus infection were collected and tested with this kit, the sensitivity is 96.36%. A total of 940 sera from healthy people were collected and tested with this kit, the specificity is 98.83%
2. In a clinical evaluation, a total of 1365 sea were tested with this kit and reference kit in parallel. The sensitivity is 100.00%, the specificity is 98.79%, the accuracy is 99.05%, the Kappa value is 0.97.
3. No cross reactivity was observed with the specimen positive to new bunyavirus, Japanese encephalitis virus, tsutsugamushi, hantavirus, influenza virus, HIV and HBsAg. Rheumatoid factors (RF) positive specimens have no effect on the assay.

LIMITATIONS

  1. Positive results must be confirmed with another available method and interpreted in conjunction with the patient clinical information. The assay is designed to achieve very high performance characteristics of sensitivity and specificity and the “sandwich model” minimizes the unspecific reactions due to interference with unknown matters in specimen (false positive results).

  2. Antigen may be undetectable during the early stage of the disease. Therefore, negative results obtained with this kit are only indication that the specimen does not contain detectable level of DENV NS1 antigen and any negative result should not be considered as conclusive evidence that the individual is not infected with dengue virus.

  3. If, after retesting of the initially reactive specimens, the assay results are negative, these specimens should be considered as non-repeatable (false positive) and interpreted as negative. As with many very sensitive ELISA assays, false positive results can occur due to the several reasons, most of which are related but not limited to inadequate washing step. For more information regarding Wantai ELISA Troubleshooting, please refer to Wantai’s “ELISAs and Troubleshooting Guide”, or contact Wantai technical support for further assistance.

  4. The most common assay mistakes are: using kits beyond the expiry date, bad washing procedures, contaminated reagents, incorrect assay procedure steps, insufficient aspiration during washing, failure to add specimens or reagents, improper operation with the laboratory equipment, timing errors, the use of highly hemolyzed specimens or specimens containing fibrin, incompletely clotted serum specimens.

  5. The prevalence of the marker will affect the assay’s predictive values.

  6. This kit is intended ONLY for testing of individual serum or plasma specimens. Do not use it for testing of cadaver specimens, saliva, urine or other body fluids, or pooled (mixed) blood.

  7. This kit is a qualitative assay and the results cannot be used to measure antigen concentration.

  8. This kit cannot differentiate the infection of different DENV types.