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Chembio Diagnostics Gets Brazilian Regulatory Approval for Dengue POC Test

NEW YORK (360Dx) – Chembio Diagnostics today announced it has received Brazilian health agency approval for its DPP Dengue point-of-care system in collaboration with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to the country's Ministry of Health.

Approval for the dengue test — which came from Brazilian health regulator Agência Nacional de Vigilância Sanitária (ANVISA) — is important "considering that the number of dengue cases in Brazil tripled compared to last year," John Sperzel, Chembio’s CEO, said in a statement.

He noted that the firm now has multiple point-of-care tests available in Brazil, and it anticipates fulfilling a recently announced order from Bio-Manguinhos for its dengue, chikungunya, and Zika tests.

Chembio’s DPP Dengue test allows simultaneous and discrete detection of antibodies against all four dengue serotypes for active infection by dengue virus by measuring immunoglobulin M (IgM), and for prior exposure to the dengue virus by measuring immunoglobulin G (IgG). Such a capability is important for both treatment and surveillance, Chembio said.

When Brazil’s Instituto Nacional de Controle de Qualidade em Saúde evaluated the dengue test using patient samples, it demonstrated a sensitivity of 96.6 percent and specificity of 99 percent for IgM antibody detection, and sensitivity of 100 percent and specificity of 99 percent for IgG antibody detection, Chembio said.

The test, a chromatographic immunoassay, is performed using a 10µL drop of fingertip blood and provides quantitative results in about 15 minutes when used with the company’s handheld DPP Micro Reader.

In April, the Medford, New York-based firm announced it had received the Brazilian health agency's approval for its DPP Zika/Dengue/Chikungunya point-of-care system in collaboration with Bio-Manguinhos/Fiocruz.