5 x Strep A Professional Testing Kit

This test is for professional use only

What is Strep A?

Group A Streptococcus (group A strep) is a type of bacterium commonly found on the surface of the skin and inside the throat. It can cause many different infections that range from minor illnesses to very serious and deadly diseases. The most common infections caused by Strep A include:

• Impetigo
• Cellulitis
• Strep Throat
• Tonsillitis
• Ear infection
• Sinusitis
• Scarlet Fever

In rare cases, Strep A can penetrate deeper inside the tissues and organs of the body and become an invasive infection. These infections are much rarer and usually affect certain groups of people, including babies, elderly people, people with diabetes, and people with weak immune systems (for example, because of cancer treatment or HIV). Examples of invasive infections include:

• Pneumonia
• Septicaemia
• Meningitis

How is the infection contracted?

It can be spread in droplets in the coughs or sneezes of someone with an infection, or through direct contact with an infected person or contaminated object.

Why do I need this Test?
Whilst most infections that are caused by Strep A are fairly minor, in some cases antibiotics may be required.

How do I perform the Test?
It is very simple – just use the enclosed cotton swab to obtain a sample from the throat, mix it with the test solutions and then add 3 drops to the test cassette. You will then be able to read the results after 5 minutes. A positive or negative result is indicated by 2 or only 1 line in the test window respectively

 

DIRECTIONS FOR USE

Allow the test, reagents, throat swab specimen to reach room temperature (15-30℃) prior to testing.

1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Hold the Extraction Reagent 1 bottle vertically and add 6 full drops (approximately 240μL) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in color. Hold the Extraction Reagent 2 bottle vertically and add 5 full drops (approximately 160μL) to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the color of the solution from red to yellow. See illustration 1.
3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, Leave the swab in the extraction test tube for 1 minute. See illustration 2
4. Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab. See illustration 3
5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. Add three drops of the solution (approx.100ul) to the sample well and then start the timer. Read the result at 5 minutes. Do not interpret the result after 10 minutes. See illustration 4 and illustration 5.

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Strep A was detected in the specimen.

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Strep A present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Strep A antigen is not present in the specimen, or is present below the detectable level of the test. The patient’s specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms are not consistent with results, obtain another specimen for culture.

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.