DENV Detect™ NS1 ELISA Kit
FDA Cleared – For In Vitro Diagnostic Use
The DENV DetectTM NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 – day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision. This assay is not FDA cleared or approved for testing blood or plasma donors.
The complete kit includes one 96 well strippable plate with all necessary reagents and controls.
- FDA Cleared & CE Marked
- Early NS1 antigen detection (within first 7 days onset of symptoms)
- Helps differentiate dengue from other flaviviruses that may cross react with dengue antibodies but not with the antigen
- High Sensitivity & Specificity: 86.6% PPA & 97.8% NPA with prospectively collected positive and negative confirmed clinical specimens
- Kit can be performed in parallel with InBios’ FDA Cleared dengue IgM ELISA for presumptive diagnosis of acute or convalescent stage dengue virus
- Patented Technology: This product is covered by one or more of U.S. Pat. Nos. 6,870,032 and 7,282,341, used under license from Institut Pasteur.
|Catalog No.||Format||Quantity/Kit||Incubation Time||Sample Type||Storage||Shelf Life|
|DNS1-1||Antigen Detection||96 wells/Plate||60+30+20+1||Serum||2-8℃||12 months|
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Pal, S., Dauner, A. L., Mitra, I., Forshey, B. M., Garcia, P., Morrison, A. C., … Wu, S.-J. L. (2014). Evaluation of Dengue NS1 Antigen Rapid Tests and ELISA Kits Using Clinical Samples. PLoS ONE, 9(11), e113411. http://doi.org/10.1371/journal.pone.0113411
Hyeyoung Lee. M.D., Ji Hyeong Ryu, B.S., Hye-Sun Park, M.S., Ki Hyun Park, M.S., Hyunjoo Bae, B.S., Sojeong Yun, B.S., Ae-Ran Choi, B.S., Sung-Yeon Cho, M.D., Chulmin Park, Ph.D., Dong-Gun Lee, M.D., Jihyang Lim, M.D., Jehoon Lee, M.D., Seungok Lee, M.D., Soyoung Shin, M.D., Haeil Park, M.D., and Eun-Jee Oh, M.D., Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies, Ann Lab Med. 2019 Nov;39(6):566-571.