The firm said that its multiplex point-of-care test uses 10 microliters of blood from a fingertip and provides quantitative results in about 15 minutes.
The firm is working with a new center in Dakar, Senegal, that will deploy new tests based on the platform to support early detection of tropical diseases.
The firm said it has multiple point-of-care tests available in Brazil and anticipates soon fulfilling an order for its dengue, chikungunya, and Zika tests.
The approval advances Chembio’s commercial agreement with Bio-Manguinhos to develop and supply rapid diagnostic tests for Zika, dengue, and chikungunya.
The mass spec-based assay can detect viral proteins eight days after the onset of symptoms, compared to four to five days with PCR tests, its developers said.
The test is designed to identify and differentiate between Zika, dengue, and chikungunya in serum samples, even in the presence of more than one target.
Developers of POC STI platforms and assays said that the tests provide convenience, privacy, and quick results in an area of testing in need of these benefits.
The firm is taking its in-home monitoring systems for COPD and cystic fibrosis, and its professional-use sepsis confirmation system through clinical trials.
The partnership will enable the design, development, and manufacture of a test to rapidly detect dengue, Chikungunya, and Zika viruses.
The assay provides a presumptive diagnosis of dengue virus from patients' serum samples within the first seven days of clinical symptoms.