DENV Detect™IgM Capture ELISA Kit
FDA Cleared for In Vitro Diagnostic Use
The DENV DetectTM IgM Capture ELISA is for the qualitative detection of IgM antibodies to DENV recombinant antigens in serum for the presumptive clinical laboratory diagnosis of Dengue virus infection. The assay is intended for use only in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever.
The complete kit includes one 96 well strippable plate with all necessary reagents and controls.
- 1st Assay to Receive FDA Clearance.
- Performance thoroughly evaluated with clinically confirmed cases of dengue 1-4 serotypes.
- Excellent positive and negative agreement with WHO reference panel (>90%).
- Improves accuracy by monitoring background reactivity with a normal cell antigen.
- Employs a simple, one step ratio method of interpretation.
- CE Marked
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Namekar M, Ellis EM, O’Connell M, Elm J, Gurary A, Park SY, Imrie A and Nerurkar VR. Evaluation of a New Commercially Available Immunoglobulin M Capture Enzyme-Linked Immunosorbent Assay for Diagnosis of Dengue Virus Infection. J Clinical Microbiol. 2013; 51:3102.
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.