Wondfo Strep A Self-Test

Individually packaged Strep A Self Tests for at home use.

CE Certified and MHRA Registered

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Wondfo Strep A Self-Test

Wondfo Step A Self Test

The Wondfo One Step Strep A Home Test is a rapid chromatographic immunoassay intended for use by home users and healthcare professionals as a qualitative screening in vitro diagnostic test for the detection of group A streptococcal antigen. (Pharyngitis, Tonsillitis, Impetigo, Scarlet Fever).

This easy to use test is highly accurate and requires only a throat swab. They are easy to store, have a long shelf life and provide accurate results for in just 10 minutes indicating wether the user has a Strep infection or not.

trick-mark-iconWondfo Strep A Self-test kit is fully home-use approved and validated by the Public Health England Porton Down and is registered with the MHRA & CE approved.

trick-mark-iconIt is also ISO-certified. Wondfo Strep A Self-test kit packs are used and trusted by several companies worldwide.

benefits of Wondfo Strep A Self-Test

Wondfo-Step-A-Self-Test Results can be obtained

Results can be obtained
in as little as 10 minutes.

Wondfo-Step-A-Self-Test Easy to use

Easy to use,
no equipment required

Wondfo-Step-A-Self-Test Stored at room temperature

Stored at room temperature
or refrigerated between 4-30°C.

Going Through the wondfo strep a self-Test Process

Allow the device and buffers to equilibrate to room temperature (10~30°C) prior to testing.

Add 4 drops of buffer A and 4 drops of buffer B respectively into the extraction tube and fully mix. The color of mixed liquid should become yellow.

STEP 1

Collect the throat swab specimen with the sterile swab that is provided in the kit. Testing
should be ideally performed immediately after the specimens have been collected.


STEP 2

Place the specimen extraction swab into the tube. Swirl the swab for ten times. Leave the swab
in the tube for one minute. Then remove the swab while squeezing the swab head against the
inside of the extraction tube as you remove it to expunge as much liquid as possible from the swab.
Discard the swab.


STEP 3

Remove the test cassette from its sealed pouch by tearing at the notch and place it on a clean, dry,
level surface. Add 3 drops of mixed liquid specimen from the extraction tube to the sample well
(with an arrow mark) of the test cassette by inverting and squeezing the tube as show.


STEP 4

Wait for 10 minutes and read the results. Do not read results after 15 minutes.

Note: There is no meaning attributed to line color intensity or width

Results Interpretation

After about 10 minutes, you should have your results ready, with three possible outcomes. It can either turn out positive, negative, or invalid. The following is how they will come out and how to interpret them:

Negative Test Result

If only one colored band appears in the control (C) region, no color band appears in the test region,
the result is negative. It indicates that the concentration of the group A streptococcal antigen is zero
or below the detection limit of the test.


Positive Test Result

If two color bands are visible both in the test (T) band and the control (C) band, the result is positive.
It indicates that you may be in a stage of Strep A infection and should consult with your doctor.


Invalid Test Result

No visible band at all, or there is a visible band only in the test region but not in the control region.
This is an indication of procedure error and/or that test reagent deterioration has occurred. Repeat
test with a new test kit. If test still fails, please contact the distributor or the store where you bought
the product, with the lot number.

Contents of the wondfo strep a self-Test kit

trick-mark-icon1 Individual sealed pouch contains Test Device and Desiccant Pouch

trick-mark-icon1 Extraction Tube

trick-mark-icon1 Sterile Throat Swab. The swab is for collecting samples.

trick-mark-iconBuffer A and B (Warning: Buffer B Toxic if swallowed).

trick-mark-iconLeaflet with Instructions For Use.

STORAGE: STORAGE: Store at 4~30ºC in the sealed pouch up to the expiration date. Keep away from sunlight, moisture and heat. DO NOT FREEZE. Preferably open the pouch only shortly before the test. Please use the test kit within 1 hour after opening the pouch.

frequently asked questions

How accurate is the Wondfo One Step Strep A Swab Test?

This is the most accurate One Step Strep A Swab Test currently available:
Sensitivity: 97.22%
Specificity: 98.86%
Results are available after just 10 minutes.

Is this test kit government approved?

Yes. All of our test kits have CE and ISO certification and MHRA registration for home use and self testing.

What is Strep A (Streptococcus)?

Group A Streptococcus is one of the most significant human pathogens causing acute:
Pharyngitis, Tonsillitis, Impetigo, Scarlet Fever.

Why should I test for Strep A?

It is very important to differentiate streptococcal infection from other etiologic agents (e.g., viral, mycoplasmal,
or chlamydial) so that appropriate treatment can be sought.

Early diagnosis and treatment of group A streptococcal pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis. So it is useful having a home test within reach to be able to make a diagnosis at the first sign of symptoms.

Brand

Wondfo

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Instruction Leaflet

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CE / TUV Certificate

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HMRA Registeration

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