Strep a Rapid Test Medical Device Infectious Disease Diagnostic Kit

• Type: IVD Reagent
• Material: Plastic
• Specimen: Nasal
• Ready Time: 5mins
• Power Source: Manual
• Shelf Life: 24 Months
• Model NO.: ST-005
• Storage: Room Temperature 4-30
• Certificate: CE, ISO13485
• Transport Package: Carton
• Specification: Cassette
• Trademark: SD
• Origin: Guangzhou
• HS Code: 3822190090
• Production Capacity: 5000000pieces/Year

Product Description

Strep A Rapid Test Medical Device Infectious Disease Diagnostic Kit

Strep A Test?

Strep A Test is a specific immunological test for the detection of Group A streptococcus bacteria in throat infections. It helps to quickly know if a sore throat is caused by a Strep A or other germs (usually viruses) which do not require antibiotic treatment.

The Strep A Test should be performed in case of throat symptoms such as red/swollen throat or tonsils, body aches, headaches, nausea, vomiting or listlessness. A positive result means that the Group A strep was present in the throat sample and you should consult a physician, who will decide about the next step.

 

WHY DO I NEED A STREP A TEST?

 If you or your child has symptoms of strep throat. These include:

• A sudden and severe sore throat
• Pain or difficulty swallowing
• Fever of 101° or more
• Swollen lymph nodes

HOW DOES STREP A TEST WORK?

Group A ß-hemolytic streptococcus bacteria may be involved in case of sore throat infections. In order to treat it using antibiotic therapy, it is first necessary to identify it. Thanks to the specific extraction process of throat swab samples, a Group A streptococcus marker (LPS antigen) can be isolated and further identified using specific anti-LPS antigen antibodies. Quickly and reliable results in just 4 minutes. Evaluation reports show an overall agreement of 96,4% with reference method.

WHAT DOES THE TEST PACK CONTAIN?

• Instructions for use
• 1 sterile swab
• 1 sterile wooden tongue depressor
• 1 paper workstation
• 1 empty plastic extraction tube
• 1 dropper vial containing the diluent for solution 1 (blue cap)
• 1 dropper vial containing the diluent for solution 2 (green cap)

1 sealed aluminium bag containing:

• 1 strip test
• 1 desiccant sachet

SPECIMEN COLLECTION AND PREPARATION
1.   Collect  the  throat  swab  specimen  with  the  sterile  swab  that  is provided in the kit.
2.    Hold the tongue down with a tongue depressor. Swab the posterior pharynx, tonsils and other inflamed areas . Avoid touching the tongue, cheeks and teeth with the swab.
3.   Testing should be ideally performed immediately after the specimens have been collected.


HOW TO DO THE TEST?
Allow the device and buffers to equilibrate to room temperature (10~30°C) prior to testing.
1.   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.
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.
3.   Cap the tube and  mix contents  by gently swirling. The extraction specimen must be tested immediately.
4.   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.
5.   Wait for 10 minutes and read the results. Do not read results after 15 minutes .

HOW TO READ THE RESULTS?
Positive (+)
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.
Negative (-)
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.
Invalid
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.







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