Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485

Brand Name:Aichek
Certification:CE
Model Number:STR-A01
Minimum Order Quantity:5000 Test
Payment Terms:T/T
Place of Origin:China
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Location: Hangzhou Zhejiang China
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
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Product Details

Infection Disease Strep A Antigen Rapid Test with CE certificate uncut sheet

Product Name

Strep A Antigen Rapid Test uncut sheet

FormatsStrip(3mm)Device(4mm) uncut sheet
Place of OrigenChina
SpecimenUrine
Read Time15 minutes
Shelf life2 years
Packageuncut sheet
Storage2℃-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

MethodCultureTotal Results

Strep A

Rapid Test

ResultsPositiveNegative
Positive1027109
Negative6377383
Total Results108384492

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 StreptococcusNeisseria meningitidisSerratia marcescens
Group F StreptococcusNeisseria siccaKlebsiella pneumoniae
Streptococcus pneumoniaeBranhamella catarrhalisBordetella pertussis
Streptococcus mutansGroup C StreptococcusNeisseria gonorrhea
Staphylococcus aureusGroup G StreptococcusNeisseria subflava
Corynebacterium diphtheriaStreptococcus sanguisHemophilus influenza
Candida albicansEnterococcus faecalis
Pseudomonas aeruginosaStaphylococcus 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.

China Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485 supplier

Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485

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