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The test is fully automated from sample to result interpretation and requires one whole-blood sample tube with no manual sample preparation necessary.
The agency said it strongly recommends the use of POC nucleic-acid testing to diagnose HIV in infants and children younger than 18 months.
Roche Diagnostics CEO Thomas Schinecker said the infrastructure put in place due to the pandemic will allow for more diagnostic testing globally.
The findings stem from a recent meeting of a WHO Guideline Development Group convened to address challenges with TB diagnosis and related drug-resistance.
The deal will enable PerkinElmer to grow its infectious disease testing portfolio to include latent tuberculosis detection, it said.
The researchers believe that their prototype could be the basis of a portable, point-of-care testing platform that would enable rapid testing anywhere.
The WHO and FIND are supporting NGS-based testing in low-resource settings, while a resistance testing program at New York State's Wadsworth Center has matured.
If approved, the kit would enable automated sample preparation for the company's T-SPOT.TB test using blood samples stored up to 54 hours at room temperature.
The firm's revenues in Asia were up compared to a year ago, but the coronavirus pandemic drove down revenues in the US, Europe, and the rest of the world.
The company's CEO said that its single-molecule tethering technology has demonstrated limits of detection comparable to commercial molecular tests.