bioNexia® Strep A dipstick
is a rapid test
for the qualitative detection
of group A Streptococcal
antigen (GAS)
directly from human throat
swab specimens
™
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TEST PROCEDURE
1a
1a
1b
1b
10x
10x
R2
R2
R1
R1
4x
4x
2
2
5
5
5-10
5-10 min
min
TEST INTERPRETATION
7
7
C
C
TT
--
3
3
4x
4x
4
4
C
C
TT
1
1 min
min
C
C
TT
+
+
C
C
TT
+
+
C
C
TT
xx
xx
6
6
Why choose
bioNexia Strep A dipstick?
®
Aid in the determination of the presence of
group A Streptococcus
Result available in just 5 minutes enabling
physicians to make a quick diagnosis and
prescribe suitable treatment
Result remains stable for an additional 5 minutes
Affordable strip format
03-13 / 9303560/008/GB/A / This document is not legally binding. bioMérieux reserves the right to modify specifications without notice. BIOMERIEUX, the blue logo and bioNexia are used, pending and/or registered trademarks
belonging to bioMérieux, or one of its subsidiaries, or one of its companies / bioMérieux SA RCS Lyon 673 620 399 / Photos: Comeuroconcept, C. Ganet / Printed in France / THERA Conseil / RCS Lyon B 398 160 242
Easy-to-use, all-inclusive kit
Clinical Background
Acute sore throat is a symptom often caused by an inflammatory process
in the pharynx, tonsils or nasopharynx. Most of these cases are of viral
origin and occur as part of the common cold,1 requiring only symptomatic
treatment. However, when bacterial pathogens are the cause of pharyngeal
infections, antibiotic treatment may be required.
eta-hemolytic group A Streptococcus (GAS) is a major cause of upper
B
respiratory tract infection, such as tonsillitis or pharyngitis. Rapid, accurate
diagnosis of a GAS infection can help physicians to prescribe antibiotic
treatment only when necessary, helping to reduce incidence of adverse
effects and the spread of bacterial resistance.
arly diagnosis and treatment of group A streptococcal pharyngitis has also
E
been shown to reduce the severity of symptoms and further complications,
such as rheumatic fever and glomerulonephritis.2 ,3
1. Pelucci, C., Grigoryan, L., Galeone, C. Guideline for the management of acute sore throat. ESCMID Sore Throat Guideline Group. Clin Microbiol Infect. 2012;18:1-27.
2. Facklam, R.R. and Carey, R.B., Streptococci and Aerococci, Manual of Clinical Microbiology, 4th ed., Lennette, E.H., Balows, A., Hausler, W.J. and Shadomy, H.J.
editors, American Society for Microbiology; 1985, PP154-175.
3. Edwards, E.A., Phillips, I.A., and Suiter, W.C. Diagnosis of group A streptococcal infections directly from throat secretions, J. Clin. Microbiol. 1982;15:481-483.
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Technical data:
Reference: 414 556 (25 tests)
Analytical sensitivity:
1x104 org/swab
Shelf-life: 24 months from
date of manufacturing
Storage temperature: +2°C to
+30°C
Content of the kit
- 25 test strips in individually
sealed pouches
- 25 sterile swabs
- 25 extraction tubes
- 25 sterile tongue depressors
- Two reagents: R1 and R2
- Controls: 1 positive, 1 negative
- 1 quick user guide
- 1 package insert
- 1 reagent holder
Dimensions of the kit
Length: 220 mm
Width: 180 mm
Height: 86 mm
Weight: 432 g