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The two organizations are collaborating to perform a standardized evaluation of currently available molecular diagnostic tests to assess test performance.

Initially, FIND and the WHO will work to develop national essential diagnostics lists, as well as to collect data to support countries in their aim to provide universal health coverage.

Mere weeks after the 2019-nCoV sequence was released, firms, agencies, and research groups have already created PCR-based tests.

At Medica, the two firms, whose tests have received WHO prequalification, said their tests were seeing high adoption rates in lower-resource nations.

The firm's CEO said that the approval enables global funders and national ministries of health to expand access to HIV self-testing, allowing diagnosis and treatment.

Having recently won prequalification status from the World Health Organization the British Columbia-based firm is also considering US regulatory options.

The new list comprises 122 test categories — 46 general IVDs, 69 IVDs for specific diseases, and seven test categories for screening blood donations.

Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.

The test, called Fujifilm SILVAMP TB LAM, was found to be about 30 percent more sensitive than the Alere Determine TB LAM Ag test from Abbott.

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.

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