Strep A Rapid Test
(Group A Streptococcus)
Rapid lateral flow chromatographic immunoassay for the qualitative detection of Lancefield Group A Streptococcal antigen directly from patient throat swabs. Provides definitive visual diagnostic results in 5 minutes to guide immediate targeted antibiotic stewardship and eliminate post-streptococcal sequelae.
Targeted Antibiotic Stewardship & Acute Pharyngitis Management
Over 70% of sore throats evaluated in outpatient clinics are viral in origin. Rapid Strep A testing provides instant differentiation to prevent antibiotic overuse while protecting patients against rheumatic fever.
Lancefield Specificity
Utilizes highly specific rabbit polyclonal antibodies against Lancefield Group A carbohydrate antigen, eliminating false-positive reactions with other normal oral Streptococcal strains.
- Specific to Streptococcus pyogenes
- No cross-reaction with Groups B, C, F, G
- Detects non-viable organisms post-lysis
5-Minute Bedside Turnaround
Delivers conclusive visual readouts in 5 minutes while the patient remains in the examination room, allowing immediate penicillin or amoxicillin prescription when indicated.
- Rapid sore throat triage in pediatric clinics
- Prevents acute rheumatic fever and RHD
- Eliminates unnecessary antibiotic prescriptions
All-Inclusive Reagent Chemistry
Complete with Extraction Reagents A and B with intuitive color-change validation. Fully stable at ambient room temperature up to 30°C across clinics in Dubai, Abu Dhabi, and the UAE.
- Room temperature storage: 2°C – 30°C
- Color-change verification (pink to yellow)
- Supplied with external positive & negative controls
Multi-Center Clinical Evaluation (vs. Throat Culture Reference)
CE-IVD Clinical Trial Cohort (n = 525)| Diagnostic Parameter | Clinical Result | 95% Confidence Interval (CI) | Clinical Significance |
|---|---|---|---|
| Clinical Sensitivity | 94.40% | 88.3% – 97.9% | High positive agreement compared to 48-hour sheep blood agar culture |
| Clinical Specificity | 98.20% | 96.3% – 99.3% | Extremely low false-positive rate prevents inappropriate antibiotic courses |
| Total Diagnostic Agreement | 97.40% | 95.5% – 98.6% | Strong statistical concordance across diverse pediatric and adult cohorts |
| Limit of Detection (LoD) | 1.0 x 10⁴ org/swab | Calibrated Lancefield LoD | Reliably detects low-density colonial colonization in pharyngeal exudates |
| Cross-Reactivity | 0.0% Non-Reactive | Panel of 26 Commensals | Zero cross-reactivity with S. pneumoniae, S. agalactiae, or S. aureus |
4-Step Standard Operating Procedure
Standard dual-reagent chemical extraction protocol completed within 2 minutes of specimen collection.
Throat Swab Sampling
Depress the tongue with a depressor. Swab the posterior pharynx, bilateral tonsillar pillars, and any purulent exudate areas. Avoid touching cheeks, tongue, or lips.
Dual-Reagent Extraction
Add 4 drops of Reagent A and 4 drops of Reagent B to the extraction tube (color shifts from pink to light yellow). Immediately immerse the patient swab and swirl 10 times.
Incubation & Squeeze
Allow the swab to stand for 1 minute in the extraction mixture. Pinch the flexible tube sides firmly against the swab head while withdrawing to express all liquid.
Inoculation & Readout
Attach the dropper tip and dispense exactly 3 drops into the cassette sample well (S). Read results at 5 minutes. Do not interpret results past 10 minutes.
Visual Result Interpretation Guide
Rapid, intuitive colorimetric line reading provides unambiguous answers at bedside.
Definitive Test Outcomes
Evaluation of colored bands formed in the reading window:
Clinical Diagnostic Best Practices
Key considerations for healthcare practitioners:
Everything Required for Point-of-Care Strep Testing
Supplied in clinical boxes of 25 tests, fully equipped with extraction reagents and controls for immediate clinic use.
Frequently Asked Questions
Need validation dossiers, regulatory certificates, or bulk clinic pricing? Contact our clinical team in Dubai.
Contact Clinical SpecialistHow quickly can results be interpreted for Strep A?
Results are interpreted between 5 to 10 minutes. Strongly positive results with high bacterial antigen concentrations may appear within 1 to 2 minutes, but negative results must be verified at 5 minutes. Do not interpret past 10 minutes.
Why is rapid Strep A testing vital for pharyngitis?
Over 70% of pharyngitis cases are viral and do not require antibiotics. A rapid 5-minute Strep A test distinguishes bacterial Streptococcus pyogenes from viral etiologies, supporting antimicrobial stewardship and preventing acute rheumatic fever.
What specimens are approved for this assay?
Standard posterior pharyngeal and tonsillar swab specimens collected using supplied sterile Dacron or flocked swabs.
What is the analytical Limit of Detection (LoD)?
The assay detects as low as 1.0 x 10⁴ organisms per swab, calibrated directly against purified Lancefield Group A carbohydrate antigens.
Does this test cross-react with other common throat flora?
No. Clinical validation confirmed zero cross-reactivity with Streptococcus pneumoniae, Streptococcus agalactiae (Group B), Staphylococcus aureus, Haemophilus influenzae, or Candida albicans.
Equip Your Clinic With QuRapid Strep A Rapid Diagnostic Tests
Order CE-IVD certified Strep A (Group A Streptococcus) Rapid Test Kits with same-day dispatch across Dubai, Abu Dhabi, and the UAE. Wholesale volume pricing available for ENT clinics, pediatric practices, and urgent care centers.