Infection Disease Strep A Antigen Rapid Test with CE certificate uncut sheet
| Product Name |
Strep A Antigen Rapid Test uncut sheet
|
| Formats |
Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen |
China |
| Specimen |
Urine |
| Read Time |
15 minutes |
| Shelf life |
2 years |
| Package |
uncut sheet |
| Storage |
2℃-30℃ |
For professional in vitro diagnostic use only.
INTENDED USE
The Strep A Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
PERFORMANCE CHARACTERISTICS
Table: Strep A Rapid Test vs. PCR Test
| Method |
Culture |
Total Results |
|
Strep A
Rapid Test
|
Results |
Positive |
Negative |
| Positive |
102 |
7 |
109 |
| Negative |
6 |
377 |
383 |
| Total Results |
108 |
384 |
492 |
Relative Sensitivity: 94% (88%-98%)* Relative Specificity: 98% (96%-99%)*
Accuracy: 97% (96%-98%)* * 95% Confidence Intervals
Cross-Reactivity
The following organisms were tested at 1.0 x 107 organisms per test and were all found to be negative when tested with the Strep A Rapid Test Device. No mucoid-producing strains were tested.
| Group B Streptococcus |
Neisseria meningitidis |
Serratia marcescens |
| Group F Streptococcus |
Neisseria sicca |
Klebsiella pneumoniae |
| Streptococcus pneumoniae |
Branhamella catarrhalis |
Bordetella pertussis |
| Streptococcus mutans |
Group C Streptococcus |
Neisseria gonorrhea |
| Staphylococcus aureus |
Group G Streptococcus |
Neisseria subflava |
| Corynebacterium diphtheria |
Streptococcus sanguis |
Hemophilus influenza |
| Candida albicans |
Enterococcus faecalis |
|
| Pseudomonas aeruginosa |
Staphylococcus epidermidis |
|
POL Studies
Three physicians’ offices were used to conduct an evaluation of the Strep A Rapid Test Device. Personnel with various educational backgrounds performed the testing. Each physician’s office tested a randomly coded panel of samples consisting of negative (20), low positive (20), and medium positive (20) for three days. The results obtained had a 96% correlation with the expected results.
SUMMARY
Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.1 Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.3,4
The Strep A Antigen Rapid Test is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.
Product Tags:
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Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485 Images
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