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RAPID Streptococcus A
Registration Certificate: No. RZN 2024/23 732
A lateral flow immunoassay for qualitative detection of Group A Streptococcus antigen in a human oropharyngeal swab.
The Current Diagnostic Landscape
Group A Streptococcus (Strep A) is a leading bacterial cause of acute pharyngitis and tonsillitis in both pediatric and adult populations. Since bacterial and viral infections often present with nearly identical clinical symptoms, differentiating between them based on physical examination alone is highly challenging.
Challenges in Disease Management
The inability to accurately distinguish the pathogen leads to two critical public health issues:
Challenges in Disease Management
The inability to accurately distinguish the pathogen leads to two critical public health issues:
- Antibiotic Overuse: Unnecessary prescriptions for viral infections, contributing to global antimicrobial resistance.
- Severe Complications: The risk of missing bacterial cases, which can lead to serious post-streptococcal complications, such as rheumatic fever or acute glomerulonephritis.
Clinical Impact & Benefits
01
Antimicrobial Stewardship
Confirmed Strep A detection provides a definitive clinical rationale for antibiotic prescription. Conversely, a negative result supports the decision to withhold antibiotics, preventing unnecessary treatment and combating global antimicrobial resistance.
02
Prevention of Rheumatic and Renal Complications
Timely diagnosis and appropriate therapy are critical for mitigating the risk of severe post-streptococcal sequelae. This includes the prevention of acute rheumatic fever, valvular heart disease, and post-streptococcal glomerulonephritis.
03
Outbreak Control in Communal Settings
Rapid screening of pediatric patients with sore throats enables immediate identification of the infection source. This allows for prompt isolation and treatment, effectively breaking the chain of transmission in schools, daycare centers, and healthcare facilities.
Key Advantages
Accurately distinguishes between viral and bacterial pathogens, ensuring the correct clinical path from the outset.
Prevents the unjustified prescription of antibiotics, preserving their efficacy and reducing the risk of side effects.
Enables immediate treatment initiation, effectively preventing severe post-streptococcal complications.
Technical Specifications
Time to Result:
5 minutes
Result Stability:
45 minutes
Reproducibility:
100%
Analytical Sensitivity (LOD):
10⁴ CFU/mL
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test line “T” does not occur.
Positive result
Appearance in the test window of two colored lines: the control line “C” and the test line “T”.
The color intensity of the test line may vary.
The color intensity of the test line may vary.
Invalid result
In the test window, the control line “C” does not appear regardless of the presence of the test line “T”.
The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
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