Abbott ID NOW Strep A 2 Test Kit

Abbott (NYSE: ABT) introduced these days that the U.S. Food and Drug Administration (FDA) has cleared its next-era Influenza A & B 2 and Strep A 2 molecular assays for factor-of-care testing 1,2. These new assays permit the quickest-ever 3 time to molecular influenza A & B and Strep A effects on the factor of care.four Currently to be had at the ID NOW platform (previously Alere i), each assays were granted a Clinical Laboratory Improvement Amendments (CLIA) certificates of waiver.

The more advantageous Influenza

A & B 2 assay gives the quickest factor-of-care molecular detection and differentiation of influenza A and B virus to be had – in thirteen mins or less, with early name out of high quality effects in as low as 5 mins – and permits for room temperature garage of all check components, simplifying and streamlining check ordering and garage.

• The Strep A 2 affords molecular detection of Group A Streptococcus bacterial nucleic acid, the number one reason of bacterial pharyngitis (sore throat), extra than two times as hastily as different to be had molecular assessments – in six mins or less, with name out of high quality effects as early as mins – and not using a tradition affirmation required for bad effects.
• “These Influenza A & B 2 and Strep A 2 assays integrate velocity with efficacy for speedy shipping of molecular effects, similarly using fee for healthcare structures in which time equals money,” stated Sharon Bracken, senior vice president, Rapid Diagnostics, Abbott.
• “By turning in rapid and correct molecular effects on the factor of care, those assessments offer physicians with the self belief to provide the proper prognosis and the capacity to prescribe the proper remedy earlier.”
• “The capacity to gain early name outs for high quality check effects with molecular accuracy in as low as 5 mins for influenza and mins for Strep A is a game-converting improvement that permits spark off remedy choices on the factor of care,” stated Gregory J. Berry, Ph.D., Director, Molecular Diagnostics, Northwell Health Laboratories in Lake Success, NY.
• “Rapid trying out may assist lessen wrong antibiotic usage, that may arise whilst remedy is primarily based totally solely on a affected person’s symptoms, and contributes to antibiotic resistance.”
• The new assays are to be had in a large variety of outpatient and inpatient settings in which sufferers are an increasing number of having access to healthcare services, consisting of emergency rooms, health practitioner offices, walk-in clinics and pressing care centers.
• Such assays assist healthcare companies to make rapid, knowledgeable prognosis possible, and linkage to suitable remedy, all through a unmarried affected person visit.

ABOUT THE ID NOW (FORMERLY ALERE I) MOLECULAR PLATFORM

ID NOW, the primary CLIA-waived factor-of-care molecular platform, is a speedy, instrument-primarily based totally, isothermal machine for the qualitative detection of infectious diseases. Abbott’s particular ID NOW isothermal nucleic acid amplification era affords molecular effects in only mins, permitting clinicians to make powerful scientific choices all through a affected person visit. The preliminary Influenza A & B and Strep A assays for the ID NOW platform have been cleared in 2014 and 2015, respectively. The 1/3 assay at the platform, for respiration syncytial virus (RSV), became cleared in 2016. Abbott expects to provide ID NOW assays q4 to be used with each present Alere i devices and new ID NOW devices.

ABOUT INFLUENZA

Each year, a aggregate of influenza A and B virus lines flow into withinside the United States. The burden of influenza withinside the United States is presently envisioned to be nine to 36 million instances consistent with year. The sickness and its headaches reason as many as 140,000-710,000 hospitalizations and 12,000-56,000 deaths annually. Influenza additionally poses a massive monetary burden consisting of hospital therapy fees and lack of productivity.

ABOUT PHARYNGITIS

Pharyngitis, or irritation of the pharynx inflicting sore throat, is recognized in eleven million sufferers in U.S. emergency departments and ambulatory settings annually.6 Group A streptococcus (GAS) is the maximum not unusualplace bacterial reason of acute pharyngitis, accounting for 15 to 30 percentage of instances in youngsters and five to twenty percentage of instances in adults.7 GAS is without problems and regularly unfold amongst households and different near contacts thru respiration secretions, and contamination peaks withinside the past due wintry weather and early spring