FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of using home-collected saliva samples. The test remains prescription only.
To be clear, this isn’t the first test the agency has authorised with a home-collection option, but it is the first saliva-based COVID-19 test with a home-collection option. Rutgers’ test previously had been added to FDA’s high-complexity molecular-based LDT “umbrella” emergency use authorisation to permit testing of samples self-collected by patients at home using the Spectrum Solutions SDNA-1000 saliva collection device.
Last month FDA authorised the first diagnostic test with a home-collection option, but that test uses a sample collected from the patient’s nose with a nasal swab and saline. That authorization is for LabCorp’s COVID-19 RT-PCR test using samples patients collect themselves with LabCorp’s Pixel home collection kit.
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