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FDA Issues EUAs for Detectachem, Optolane Technologies Coronavirus Tests, Color Collection Kit

NEW YORK — The US Food and Drug Administration on Tuesday granted separate Emergency Use Authorizations for molecular SARS-CoV-2 tests developed by Detectachem and Optolane Technologies, as well as a nasal swab self-collection kit from Color.

Detectachem's MobileDetect Bio BCC19 Test Kit uses reverse transcription loop-mediated isothermal nucleic acid amplification to detect the N and E genes of SARS-CoV-2 in nasopharyngeal, anterior nasal, mid-turbinate nasal, and oropharyngeal swab specimens.

It can be used with a variety of thermo cyclers including the Stafford, Texas-based company's MD-Bio Heater, Bio-Rad Laboratories' T100, Benchmark Scientific's TC-32 Mini, Techne's 5Prime/02, Edvotek's EdvoCycler 2 and EdvoCycler Jr., and Thermo Fisher Scientific's Applied Biosystems Veriti and Applied Biosystems MiniAmp.

Optolane's Kaira 2019-nCoV Detection Kit is designed to detect the SARS-CoV-2 E and RdRp genes in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab specimens, as well as nasopharyngeal wash/aspirate, nasal aspirate, sputum, and bronchoalveolar lavage specimens.

Nucleic acid extraction is performed using Qiagen's automated QIAsymphony SP instrument and QIAsymphony DSP Virus/Pathogen Mini Kit, according to South Korea-based Optolane. The test can run on Thermo Fisher's Applied Biosystems QuantStudio 5 RT-PCR System or Applied Biosystems 7500 RT-PCR System, or Bio-Rad's CFX96 RT-PCR System.

Both tests may be used by any lab CLIA-certified to perform high-complexity tests, the FDA said.

Color's COVID-19 Test Unmonitored Collection Kit is designed for the unmonitored self-collection of nasal swab specimens at home or in a healthcare setting. Samples may be used with the Burlingame, California-based company's authorized SARS-CoV-2 LAMP Diagnostic Assay.

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