Strep A Rapid Test
Strep A Rapid Test Operation

ALLTEST Strep A Rapid Test

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    Description

    The AllTEST Strep A Rapid Test is for the qualitative detection of Strep A antigens from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

    The CE certified, MHRA registered test is suitable for Point of Care (POC) settings only.

    • 20 x tests per kit (box)
    • UK MHRA registered
    • CE for UK & EU markets
    • Control line in Red
    • Simple operation
    • Fast results in 5 minutes
    • Storage at 2-30°C
    • Sensitivity: 95.1%
    • Accuracy: 97.1%
    • Specificity: 97.8%

    Kit contents:

    • Test Cassettes
    • Sterile Swabs
    • Extraction Tubes
    • Extraction Reagent 1 Solution Bottle (2M NaNO2)
    • Extraction Reagent 2 Solution Bottle (0.027M Citric Acid)
    • Postive Control Swab
    • Negative Control Swab
    • Workstation
    • Instructions for Use

    The AllTEST Strep A Rapid Test is for Point of Care (POC) use only.

    For pricing and orders call 0114 2213344, or email hello@hygiene-uk.com

    Click HERE to learn more about Strep A and the symptoms.

    Additional information

    Pack quantity

    20

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    — Seldram Supplies

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      FAQs

      Find what you might need in our FAQ's...

      An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.

      In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes, cassettes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

      The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

      The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met.

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