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Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485

    Buy cheap Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485 from wholesalers
     
    Buy cheap Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485 from wholesalers
    • Buy cheap Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485 from wholesalers

    Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485

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    Brand Name : Aichek
    Model Number : STR-A01
    Certification : CE
    Price : negotiable
    Payment Terms : T/T
    Supply Ability : negotiable
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    Rapid Strep Antigen Test Uncut Sheet Rapid Test ISO 13485

    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.

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