- Targeted Throat Pathogen Detection: Formulated with high-affinity antibodies optimized specifically for isolating and binding Streptococcus pyogenes (Group A Strep) carbohydrate antigens from throat specimens.
- Instant Sore Throat Triaging: Delivers reliable visual readouts in under 15 minutes, drastically shortening the time patient spends in waiting rooms compared to traditional 24-48 hour throat cultures.
- Optimized Clinical Sensitivity: Features industry-leading accuracy to capture low antigen loads, ensuring early-stage infections are detected with minimal risk of false negatives.
- Streamlined Swab-to-Result Workflow: Simple, mistake-proof protocol requires no clinical machinery or specialized laboratory infrastructure.
- Global Regulatory Endorsement: Manufactured in a certified facility strictly adhering to international guidelines, carrying CE, ISO, and IVD markings for compliant worldwide distribution.
- Reliable Procedural Verification: Equipped with a built-in procedural Control Line (C-Line) that automatically appears to verify adequate specimen volume and flawless fluid migration.
|
Product name |
Strep A Rapid Test Strip |
|
Item type |
STP-S21 |
|
Specimens |
Saliva |
|
Shelf life |
2 years |
|
Test Time |
Waiting about 15 minutes |
|
Certificate |
CE, ISO:13485 |
|
OEM |
Acceptable |
|
Storage condition |
The kit should be stored at 2-30°C |
STORAGE AND STABILITY
Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The shelf life printed on the sealed bag is stable for two years. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
SPECIMEN COLLECTION AND STORAGE
Throat sample:
Only use reagents and sterile swabs provided in the kit.
- Collect the throat swab specimen with the sterile swab that is provided in the kit. Swab the posterior pharynx, tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab.
- Testing should be performed immediately after the specimens have been collected. Swab specimens maybe stored in a clean, dry plastic tube for up to 8 hours at room temperature or 72 hours at 2-8°C. Transport swabs containing modified Stuart's or Amies medium can also be used with this product.
- If a culture is desired, lightly roll the swab tip onto a Group A selective (GAS) blood agar plate before using the swab in the Strep A Rapid Test.
FAQ
Q: What are the clinical guidelines for collecting a proper sample using the Throat Test Kit?
A: Accurate results depend entirely on correct sampling. Use the sterile swab to vigorously rub the posterior pharynx, both tonsils, and any red or inflamed areas. Avoid touching the tongue, teeth, cheeks, or uvula with the swab, as saliva contamination can dilute the bacterial load and potentially lead to false-negative results.
Q: Can this Strep A Throat Test Kit differentiate between a bacterial throat infection and a viral sore throat?
A:Yes. This kit is highly selective for the Group A Streptococcus antigen (bacterial). It will not react to viral pathogens like those causing the common cold or influenza. This specificity allows physicians to instantly rule out viral infections and accurately diagnose bacterial pharyngitis, preventing unnecessary antibiotic therapy.
Q: Is this Rapid Throat Test Kit safe and validated for use on pediatric/children patients?
A: Absolutely. Strep A infections are most prevalent among children and adolescents (ages 5 to 15). This throat test kit is fully validated and highly reliable for pediatric diagnostics. The non-invasive, flexible throat swabs provided are designed to minimize patient discomfort during sample collection in pediatric clinics and urgent care environments.
Q: Will taking antibiotics or using medicated throat sprays affect the accuracy of the test?
A: Yes, therapeutic interventions can alter test readouts. If a patient has already started an antibiotic regimen or is using heavy antibacterial throat sprays/lozenges, the antigen level in the throat may drop below the detectable limit. It is highly recommended to perform this rapid throat test before initiating any antibiotic treatment.
Q: How should we interpret a very faint line in the Test region, and does the color intensity of the lines matter?
A:
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