Abbott Panbio Covid-19-Flu A&B Rapid Panel Instructions
- October 30, 2023
- Abbott
Table of Contents
ENABLE TIMELY DIFFERENTIAL
DIAGNOSIS AND TREATMENT
OF COVID-19 AND FLU A&B USING A SINGLE SWAB
PANBIO™ COVID-19/FLU A&B RAPID PANEL (NASOPHARYNGEAL)
- For patients presenting symptoms or suspected of current COVID-19, Flu A and/or B infection
- Only 1 nasopharyngeal swab for both COVID-19 and Flu A&B
- Simplified workflow with pre-filled buffer tube
- No instruments needed to interpret results
- Results in 15 minutes
Panbio ™ is the trusted brand used in more than 100 countries.
DESIGNED FOR EASY TESTING
| | 
---|---|---
PRE-FILLED BUFFER TUBE WITH INTEGRATED DROPPER CAP.
NO MANUAL FILLING NEEDED| ONLY ONE SPECIMEN COLLECTING SWAB NEEDED| SIMPLE
TEST CASSETTE DESIGN WITH ONE SAMPLE WELL
TEST PROCEDURE
Consult Instructions for Use for complete procedure.
SPECIFICATIONS
- TEST TIME: 15 MINUTES
- STORAGE: 2°C–30°C
- CE MARK
- SAMPLE TYPE: Nasopharyngeal (NP) swab
PERFORMANCE
| COVID-19| COVID-19
(Ct≤30)| FLU A| FLU B
---|---|---|---|---
SENSITIVITY| 88.00%| 94.40%| 92.00%|
SPECIFICITY| 100%| 100%| 100%|
95% Cl (Sens.)| 80% – 93.6%| 87.5% – 98.2%| 80.8% – 97.8%
95% CI (Spec.)| 98.2% – 100%| 98.2% – 100%| 98.2% – 100%
INTENDED USE: The Panbio™ COVID-19/Flu A&B Rapid Panel (NP) is an in
vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 and
Influenza A&B antigen (Ag) in human nasopharyngeal swab specimens from
individuals, who meet COVID-19 and Influenza clinical and/or epidemiological
criteria. Panbio™ COVID-19/Flu A&B Rapid Panel (NP) is for professional use
and is intended to be used as an aid in the diagnosis of SARS-CoV-2 and
Influenza infection. The product may be used in laboratory and non-laboratory
environment.
The test provides preliminary test results. Negative results don’t preclude
SARS-CoV-2 and Influenza A&B infection and they cannot be used as the sole
basis for treatment or other management decisions. Negative results should be
combined with clinical observations, patient history, and epidemiological
information.
ORDER INFORMATION
- Panbio™ COVID-19/Flu A&B Rapid Panel (Nasopharyngeal)
- CATALOG NUMBER: 62FK10; 10 tests/kit (control kit sold separately; catalog number: 62FK11C)
- CONTENTS: 10 Test Devices, 10 Extraction Buffer Tubes, 10 Nozzle Caps, 10 Sterilized Nasopharyngeal Swabs For Specimen Collection, 1 Tube Rack, 1 Instructions For Use (IFU) with Quick Reference Guide (QRG)
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COL-12204-01 05/22