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The anti-SARS-CoV-2 antibodies for classes IgA and IgG are two of the first antibody detection tests to receive CE making and be made available for SARS-CoV-2 testing.
The assay, which is also CE-IVD-marked, detects SARS-CoV-2 ORF1a and N genes and has a limit of detection of 20 copies per mL using a 400 µL sample.
The firm said it saw "significant deterioration" in February due to "ongoing and protracted" disruptions resulting from the novel coronavirus and an extended Lunar New Year holiday.
Public Health England will use the company's Victor EnLite instrument and EnLite Neonatal TREC kit at three of six sites to evaluate screening newborns for "Bubble Boy" disease.
New items for the in vitro diagnostics industry for the week of Feb. 24, 2020.
PerkinElmer is providing its recently FDA-approved test for the program, which has identified one baby, so far, as positive for DMD.
The urine-based test, which was already available in several markets, does not require any specialized instrumentation and produces results in less than three minutes.
CEO Prahlad Singh said the firm is developing a PCR- and antibody-based assay for the novel coronavirus 2019-nCoV and is working with the Chinese NMPA.
News items for the in vitro diagnostics industry for the week of Jan. 20, 2020.
News items for the in vitro diagnostics industry for the week of Jan. 13, 2020.