Molecular Reagent BioFire® SpotFire® Respiratory / Sore Throat Mini Panel CLIA Waived For BioFire SpotFire System 30 Tests

Name: Molecular Reagent
Brand: BioFire® SpotFire®

REAGENT, SPOTFIRE RESPTRY/SORETHROAT MINI PNL (30/KT)

McKesson #

1285723

Manufacturer #

424537

Brand

BioFire® SpotFire®

Manufacturer

Biomerieux Inc (SPOTFIRE)

Country of Origin

Unknown

Application

Molecular Reagent

Buy American Act (BAA) Compliant

CLIA Classification

CLIA Waived

CLIA Classified

CLIA Waived

For Use With

For BioFire SpotFire System

Number of Tests

30 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Sample Type

Throat Swab Sample

Specialty

Molecular

Test Category

Respiratory

Test Format

Test Device

Test Name

Respiratory / Sore Throat Mini Panel

Test Type

PCR

Time to Results

15 Minute Results

Trade Agreement Act (TAA) Compliant

UNSPSC Code

41116131

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (SPOTFIRE R Panel Mini) is a multiplexed polymerase chain reaction (PCR) test intended for use with the BIOFIRE® SPOTFIRE® System for the simultaneous, qualitative detection and identification of multiple respiratory viral nucleic acids in nasopharyngeal swab (NPS) specimens obtained from individuals with signs and symptoms of respiratory tract infection, including COVID-19
This panel offers a condensed menu of up to 5 pathogen targets on both the respiratory and sore throat menus
Respiratory Menu: Coronavirus SARS-CoV-2, Human rhinovirus, Influenza A virus, Influenza B virus, Respiratory syncytial virus
Sore Throat Menu: Human rhinovirus, Influenza A virus, Influenza B virus, Respiratory syncytial virus, Streptococcus pyogenes (group A strep)
NPS specimens: PPA: 98.7% | NPA: 98.4%
ANS specimens: PPA 95.6% | NPA 99.1%