Wondfo One Step Strep A Self-Test
Wondfo Strep A Self-Test Procedure

Wondfo Strep A Rapid Self-Test

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    Description

    The Wondfo One Step Strep A Rapid Self-Test is a rapid chromatographic immunoassay for qualitative detection of group A streptococcal antigen from throat swab specimens. The test is intended for use as an aid in the diagnosis of group A streptococcal infection.

    The CE certified, MHRA registered test is approved for self-testing.

    • 1 x test per kit (box)
    • UK MHRA registered
    • CE for UK & EU markets
    • Simple operation
    • Fast results in 10 minutes
    • Storage at 4-30°C
    • Sensitivity: 96.6%
    • Accuracy: 98.7%
    • Specificity: 98.9%

    Kit contents:

    • 1 x Test Cassette
    • 1 x Sterile Swab
    • 1 x Extraction Tube
    • 1 x Extraction Reagent A Solution Bottle
    • 1 x Extraction Reagent B Solution Bottle
    • 1 x Instructions for Use

    The Wondfo One Step Strep A Rapid Test is designed and authorised for self-testing.

    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

    1
    Case quantity

    244

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      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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