New Products MLO September 2021

LumiraDX has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SARS-CoV-2 Ab test.

The test, which returns results in 11 minutes, utilizes a combination RBD and S1 spike SARS CoV-2 antigen for the detection of total antibody (Ab) elicited in response to recent or prior SARS-CoV-2 infection. The LumiraDx SARS-CoV-2 Ab test has been commercially available in Europe since achieving CE mark in September of 2020. The test demonstrated 100% sensitivity and 100% specificity for detection of IgM and IgG antibodies against SARS-CoV-2 in serum and plasma samples. (Photo Courtesy of LumiraDx.)

Software facilitates at-home specimen collection 

LigoLab Information System announced that its TestDirectly patient engagement platform now includes electronic processes for at-home specimen collection. The services supported by TestDirectly include online ordering of a test kit, shipping of the test kit to the patient’s home, the laboratory’s receipt of the patient’s specimen after collection, processing of the specimen, automated delivery of the test result back to the patient, and videoconferencing and scheduling of consultations if needed. (Photo courtesy of LigoLab.)

Bio-Rad launches controls for SARS-CoV-2 variants

Bio-Rad Laboratories has launched the SARS-CoV-2 S Gene Alpha, Beta, Gamma and Epsilon Variant Controls as part of its Exact Diagnostics line of molecular quality control products for research testing.

These Exact Diagnostics SARS-CoV-2 S Gene Variant Controls are intended to be validated as independent external run controls and used for research testing with molecular assays targeting mutations in the Spike (S) gene. The products are to be used with assays detecting SARS-CoV-2 variant RNA and to be processed in the same manner as patient specimens to monitor all the steps of molecular assays.

This line of variant controls consist of synthetic RNA transcripts of the respective variant SARS-CoV-2 S genes in a matrix simulating transport media. Because the products also contain human genomic DNA (human gDNA; which includes the human RNase P) for internal control needs, they also enable laboratories to monitor the entire process of a molecular assay, including extraction (optional), amplification, and detection.

(Photo courtesy of Bio-Rad.)

FDA issues EUA for BD sodium-citrate blood-specimen collection tubes

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Becton, Dickinson and Company (BD) for its BD Vacutainer Plus Citrate Plasma Tubes. These are sodium-citrate blood-specimen collection tubes used to collect, transport, and store blood samples for coagulation testing.

The FDA said the tubes authorized under the EUA are for use in coagulation testing, performed by authorized laboratories, to aid in the identification and treatment of coagulopathy in patients, including patients with known or suspected COVID-19. (Photo courtesy of BD.)

Ortho Quantitative COVID-19 IgG antibody test receives FDA EUA

The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Ortho Clinical Diagnostics for the company’s VITROS Anti-SARS-CoV-2 IgG Quantitative Test.

Ortho said its new quantitative COVID-19 IgG antibody test targets the S1 spike protein and is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The new test has 100% specificity and 91.9% sensitivity at greater than 15 days after symptom onset. Ortho also offers a total antibody test to the nucleocapsid protein.

(Photo courtesy of Ortho Clinical Diagnostics.)

Labcorp to offer Qiagen test for non-small cell lung cancer

Labcorp announced the availability of therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for treatment with LUMAKRAS (sotorasib), a new treatment option developed by Amgen.

The therapy and the use of the test, which was developed by Qiagen as a companion diagnostic, received approval from the U.S. Food and Drug Administration (FDA) in late May 2021. The therascreen KRAS PCR Mutation Analysis allows labs, such as Labcorp, to determine if patients carry a specific mutation in the KRAS gene. (Photo courtesy of Qiagen.)