VITAMIN STATION Rapid test for Streptococcus A

327,-

VITAMIN STATION Rapid test for Streptococcus A

Self-diagnostic test strip for the detection of group A β-hemolytic streptococcal bacteria in throat infections. Group A β-haemolytic streptococcus (also known as Streptococcus pyogenes) is the most common bacterial cause of acute pharyngitis and is also responsible for some skin infections such as impetigo and erysipelas. Most sore throats are caused by viral infections that heal on their own without antibiotic treatment, which would be unnecessary in these cases. Infections caused by streptococcus A can sometimes resolve within a few days without treatment, but doctors prescribe antibiotics to prevent associated potentially serious complications such as rheumatic fever or acute glomerulonephritis. The Streptococcus A test is a specific immunological test for the detection of group A streptococcal bacteria in upper respiratory tract infections. It helps to quickly determine whether the sore throat is caused by streptococcus A or other agents (usually viruses) that do not require antibiotic treatment.

Content:
1 sealed aluminium bag containing: 1 test strip, 1 desiccant bag, 1 sterile swab, 1 sterile wooden tongue depressor, 1 bottle of extraction solvent 1 (blue cap): 1 ml, 1 vial of extraction solvent 2 (green cap): 1 ml, 1 empty extraction tube, 1 foam stand, 1 instruction manual
Warning:
This test is intended for in vitro diagnostic use. For external use only. DO NOT TAKE INTERNALLY.
The test is only reliable if the instructions for use are carefully followed.
Strictly follow the specified reaction time, sampling and extraction steps.
Store at a temperature between +4 °C and +30 °C. Do not freeze.
Do not use the test after the expiry date on the label and on the protective bag, or if the bag is damaged.
The Streptococcus A test is designed for single use.
Keep out of reach of children.
After use, all parts of the test can be disposed of as municipal waste.
Not suitable for children under 2 years of age.
Open the protective bag only when you are ready to use the test immediately.
The desiccant bag is not intended for testing.
If the liquid comes into contact with eyes, skin or other mucous membranes, rinse thoroughly with water and contact a doctor immediately.
Do not consume the liquid extract and other parts of the kit. In case of ingestion, seek medical attention immediately and bring the remaining parts of the kit with you, together with the instructions for use and packaging.
QUESTIONS AND ANSWERS
How does the Strep A test strip work?
In the case of upper respiratory tract infection, the cause may be group A β-hemolytic streptococcus. In order to treat this bacterium with antibiotic therapy, it must first be identified. Thanks to the specific extraction process of the throat samples, the group A streptococcal marker (LPS antigen) can be isolated and further identified using specific antibodies against the LPS antigen.
When should this test be used?
Use the test if you have symptoms of an upper respiratory tract infection, like red/obese throat or tonsils, body aches, headaches, nausea, vomiting or apathy.
Could the result be incorrect?
The results are reliable provided that all instructions have been carefully followed. The result may be incorrect if the test becomes wet before it is performed or if the throat sample is not properly collected and prepared.
How to evaluate the test if the colour intensity of the lines is different?
The colour intensity of the lines is not important for the interpretation of the test result. The lines must be clearly visible and homogeneous. The test must be scored as positive, regardless of the colour intensity of the test line.
What is the purpose of the check mark that appears near the blue end of the stripe?
When this comma appears, it only indicates the correct function of the test.
If I read the test after 10 minutes, is the result still reliable?
The result must be read within 5 to 10 minutes. Do not evaluate the test after 10 minutes.
What should I do if the test is positive?
A positive result means that group A streptococcus is present in the sample and you should consult a doctor. He will then decide on the next step.
What should I do if the test result is negative?
A negative result means that the sore throat is of viral origin or that the sample did not contain enough Streptococcus A bacteria to detect it. If symptoms persist, we recommend you see your doctor.
What is the accuracy of the Streptococcus A test?
This test is accurate. Evaluation studies show a 96.4% agreement with the reference methour Although the test is reliable, there may be the occasional false negative or false positive result.

Warning: Use the medical device in accordance with the instructions for use. Carefully read the information on safe use of the device. Keep out of reach of children.

Specifications

Medical device

Type of medical device In vitro diagnostic medical device (IVD)

Product characteristics

Product characteristics Medical device

Usage

Designed for Adults

Use

Zaměření testu na Strep throat and tonsillitis

Basic information

Evaluation method Instant results (self-diagnosis)
Method of test performance Mouth swab
Collection point Home
Evaluation time 10 min
Usability Disposable
Brand Vitamin Station

Number of pieces in package

Number of pieces in package 1 pc(s)
Code:  SPTmap030
Warranty: 24 months
Manufacturer information

Vitamin Statium Slovakia s.r.o., Hontianska 4, 936 01 Šahy

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