Status™ COVID-19/Flu A&B Test Kit- CLIA-Waived
25 Test Devices
25 Extraction Reagents in Capsules
25 Sterile Swabs
1 Positive and 1 Negative Control Swabs
1 Package insert
1 Quick Reference Instruction
By Princeton Meditech
Manufacturer Background
PBMC’s test is FDA authorized for CLIA Waiver settings at point-of-care. Results in 15 minutes, visual readout.
93.9% Sensitivity, 100.0% Specificity for SARS-CoV-2.
90%+ Sensitivity & Specificity for Influenza A & B.
FDA Status
EUA authorized for use in CLIA Waiver settings at point-of-care.
Clinical Studies
• 93.9% Sensitivity, 100.0% Specificity to SARS-CoV-2
• 90%+ Sensitivity & Specificity to Influenza A & B
• Specificity testing: No cross-reaction with other species.
• Interference testing: No interfering drugs or other factors identified.
Intended Use
Lateral flow immunoassay intended for the qualitative detection of protein antigen from SARS-CoV-2, Influenza A & B.
Qualifications
Testing must be performed by at least CLIA Waiver certified
laboratories.
Specifications
Sample Types
Nasopharyngeal swab
Antigen Type
SARS-CoV-2 protein
Influenza A/B proteins
Interpretation & Time to Result
Visual display readout, 15 minutes
Controls Included
Internal control lines appear when the test is ready to be read.
Storage and Handling
Test kits should be stored at 35-86°F. Reagents and materials are stable until the expiration date printed on the outer packaging. Do not use beyond the expiration date. The test device must remain in the sealed pouch until use. Do not freeze any contents of kit.
