Panbio Covid-19-Flu A&B Rapid Panel
Product Information: PanbioTM COVID-19/FLU A&B Rapid Panel
(Nasopharyngeal)
The PanbioTM COVID-19/FLU A&B Rapid Panel is a trusted brand
that enables timely differential diagnosis and treatment of
COVID-19 and Flu A&B using a single swab. This product is
designed for easy testing and comes with a pre-filled buffer tube
with an integrated dropper cap. Only one specimen collecting swab
is needed for testing.
The test provides preliminary test results and is intended to be
used as an aid in the diagnosis of SARS-CoV-2 and Influenza A&B
infection. However, negative results do not 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.
The product has a simple test cassette design with one sample
well and requires a nasopharyngeal swab for testing. The
performance specifications are as follows:
- Sensitivity (COVID-19): 88.0% (95% Cl)
- Sensitivity (COVID-19 Ct30): 94.4% (95% CI)
- Sensitivity (FLU A): 92.0% (95% CI)
- Sensitivity (FLU B): 100% (95% CI)
- Specificity (COVID-19): 100% (95% CI)
- Specificity (FLU A): 98.2% – 100% (95% CI)
- Specificity (FLU B): 98.2% – 100% (95% CI)
The PanbioTM COVID-19/FLU A&B Rapid Panel is not available
in all countries. Please contact your local representative for more
information.
Product Usage Instructions:
- Consult the Instructions for Use for the complete testing
procedure. - Collect a nasopharyngeal swab.
- Insert the swab into the nostril and gently advance it until
resistance is encountered at the level of the turbinates. - Leave the swab in place for several seconds to absorb
secretions. - Slowly remove the swab while rotating it.
- Place the swab into the pre-filled buffer tube and mix it well
by pressing the tube’s walls several times. - Remove the test cassette from the foil pouch and place it on a
flat, dry surface. - Add four drops of the mixed sample to the sample well using the
integrated dropper cap. Wait for 15 minutes to read the
results. - Interpret the results by observing the presence of colored
lines in the test cassette result window.
ENABLE TIMELY DIFFERENTIAL DIAGNOSIS AND TREATMENT
OF COVID-19 AND FLU A&B USING A SINGLE SWAB
PANBIOTM 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
PanbioTM 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
TEST PROCEDURE
Consult Instructions for Use for complete procedure.
4x
5x
x5
_15
MIN
4x
SIMPLE TEST CASSETTE DESIGN WITH ONE SAMPLE WELL
SPECIFICATIONS
· TEST TIME: 15 MINUTES · STORAGE: 2°C30°C · CE MARK · SAMPLE TYPE: Nasopharyngeal
(NP) swab
PERFORMANCE
SENSITIVITY SPECIFICITY
4x 95% Cl (Sens.)
95% CI (Spec.)
COVID-19 88.0%
COVID-19
(Ct30)
94.4%
FLU A 92.0%
FLU B 100%
100%
100%
100%
100%
80% – 93.6% 87.5% – 98.2% 80.8% – 97.8% 92.9% – 100%
98.2% – 100% 98.2% – 100% 98.2% – 100% 98.2% – 100%
INTENDED USE: The PanbioTM 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. PanbioTM 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
· PanbioTM 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)
CONTACT YOUR LOCAL REPRESENTATIVE TODAY.
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