PRODUCT FOCUS :: ASSAYS
Assays are key tools to diagnose diseases A
SARS-CoV-2 or flu assays
Microfluidic immunofluorescence assay The LumiraDx SARS-CoV-2 Ag Test is a rapid microfluidic immunofluorescence assay for use with the
LumiraDx Platform intended for the qualitative detection of the nucleocapsid protein antigen to SARS- CoV-2 directly from anterior nasal swab and nasopharyngeal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset or from individuals without symptoms or other epidemiological reasons to suspect COVID-19. LumiraDx
Rapid flu test The Immunocard STAT! Flu A&B is a rapid qualitative test for the differentiated detection of influenza
A and B directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/washes specimens from patients with signs and symptoms of respiratory infection. Results in 10-15 minutes for positives and 15 minutes for negative samples. It is a CLIA-waived test. Meridian Bioscience
ssays are at the core of any clinical laboratory operation. Indeed, more than 7 billion lab tests are performed in the United States each year, according to the American Clinical Laboratory Association.1 In 2019, Medicare alone spent $7.68 billion on lab tests, ranging from HbA1c assays to genetic tests associated with various
types of cancer. When measured by total spending, the most common tests among Medicare beneficiaries are blood tests, including those measuring a comprehensive group of blood chemicals; lipids, thyroid stimulating hormone, and a complete blood cell count.2 But a conversation about lab testing is not complete without mentioning SARS-CoV-2. Since the beginning of the COVID-19
pandemic in 2020, U.S. clinical labs have performed more than 673.5 million tests to detect the virus, the Centers for Disease Control and Prevention (CDC) reported.3 Medical Laboratory Observer features a small sampling of assays in this issue.
Lateral flow antigen test The Sofia 2 SARS Antigen FIA is a lateral-flow test, read by Quidel’s Sofia 2 Fluorescent Immu-
noassay Analyzer, for rapid detection of SARS-CoV-2 from anterior nares specimens. It delivers accurate, objective, automated results in 15 minutes. Workflows include a walk-away mode for individual tests and read-now mode for batch processing. Quidel
SARS-CoV-2 variant detection The NEXTFLEX Variant-Seq SARS-CoV-2 Kit v2 detects all mutations associated with SARS-CoV-2
variants in a PCR-positive sample. With the incorporation of normalization beads, this kit reduces turn-around time by three hours. 1,536 UDIs incorporated in the kit enable the sequencing of 6,000 SARS-CoV-2 libraries in one flow cell. PerkinElmer
PCR assays Seegene’s high multiplex real-time PCR assays include research-use-only tests designed
to detect SARS-CoV-2 variants (including Delta and Omicron). The tests are compatible with Seegene STARlet, which is a liquid-handling workstation designed to manage primary sample tubes to nucleic acid (NA) extraction and PCR setup. Seegene
40 JANUARY 2022
MLO-ONLINE.COM
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