Lifesign 36025 - Status Flu A&B (25 Tests) (CLIA waived for Swab Specimens)
Status Flu A & B
An in vitro rapid qualitative test that detects influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab and nasal aspirate/wash specimens.
- CLIA WAIVED for nasal swab and nasopharyngeal swab specimens
- Rapid diagnosis for early treatment
- 25 test kit
- Innovative flip test design
- Easy-to-read cassette
- Pre-measured extraction reagent capsule for increased accuracy and ease of use
- Flocked nasal swabs included for better specimen collection
- Detects H1N1 (Swine Flu)
Status Flu A & B Intended Use
Status Flu A&B is an in vitro rapid qualitative test that detects infl uenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of infl uenza A and B viral infections.
Negative test results are presumptive and it is recommended these results be confi rmed by viral culture or an FDA-cleared infl uenza A and B molecular assay. Negative results do not preclude infl uenza virus infection and should not be used as the sole basis for treatment or other management decisions.
Performance characteristics for infl uenza A and B were established during the 2007-2009 and the 2014-2016 infl uenza seasons when infl uenza A/H1N1, A/H1N1 pandemic, A/H3N2, infl uenza B/Victoria lineage, and B/Yamagata lineage were the predominant infl uenza viruses in circulation according to the Flu Activity & Surveillance reports from the CDC. When other infl uenza viruses are emerging, performance characteristics may vary.
If infection with a novel infl uenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent infl uenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Status Flu A & B Test Kit Components
- Test strip/device
- Extraction Reagent
- Positive Control Swab
- Negative Control Swab
- Sterile Swabs
This product does not contain any hazardous substances above 1% or above 0.1% levels required, depending on the hazard.
Status Flu A & BTest Kit Physical and Chemical Properties
