A test for the rapid diagnosis of angina caused by group A beta-hemolytic streptococcus.

Contraindications Streptatest express diagnostic system for in vitro determination of B-hemolytic group A streptococcus

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Method of administration and dosage Streptatest express diagnostic system for in vitro determination of B-hemolytic group A streptococcus

1.Using a tongue holder, press down on your tongue to prevent saliva from getting on the swab. Take a swab from the tonsils, throat and any inflamed, ulcerative, or exudative areas. 2. It is recommended that the test be performed immediately after taking a smear. If it cannot be done immediately, swab samples can be stored for 4 hours at room temperature (15 ° C-30 ° C) in a dry, sterile and hermetically sealed container, or for 24 hours in a refrigerator (2 ° C-8 ° C ). If you need to test another culture at the same time, use a new swab. 3. Remove the test strip from the bag just before testing. 4. Pour 4 drops of pink extraction reagent A into an extraction tube and add 4 drops of colorless extraction reagent B there. Shake the tube slightly to mix the two solutions. The mixture will change color from pink to colorless. 5. Dip the swab into the tube. Rotate the swab in the extraction solution about 10 times. Leave it on for one minute. 6. Squeeze the swab against the side of the tube to remove any excess liquid. Discard the swab. 7. Place the test strip in the extraction tube with the arrows pointing towards the extraction solution. Leave the test strip in the vial. 8. After 5 minutes the result can be read. If the concentration of the infectious agent is high, then a positive result may appear in the first minute. However, to be sure of a negative result, you must wait 5 minutes. Disregard the result after 10 minutes.

Last updated description by manufacturer 13.09.2019

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Pharmacological group

Nosological classification (ICD-10)

Composition

Appointment

Group A β-hemolytic streptococcus is one of the main causative agents of upper respiratory tract infections, especially tonsillitis, pharyngitis and scarlet fever (10 to 20% of tonsillitis in adults and 20 to 40% of tonsillitis in children are caused by β-hemolytic group A streptococcus) ... It is important to differentiate infections caused by group A streptococcus from other types of infections (for example, viral) in order to prescribe the necessary therapy.

Preliminary diagnosis and treatment of group A streptococcus infections have reduced the severity of symptoms and the number of complications such as glomerulonephritis and acute articular rheumatism.

It takes 24 to 48 hours to identify and identify the pathogen using traditional methods.

The method of immunochromatography allows you to directly detect the specific antigen of group A streptococcus with a single smear, which, in turn, allows the doctor to immediately diagnose and prescribe the necessary course of treatment.

Equipment

1.20, 5 or 2 pack. aluminum foil with test strips, desiccant bag.

2. 20, 5 or 2 swabs with CE marking.

3. 20, 5 or 2 extraction tubes.

4. 20, 5 or 2 tongue depressors with “CE” mark.

5. Jar with extracting reagent A (sodium nitrite 2 M), 10 ml.

6. Jar with extracting reagent B (acetic acid 0.4 M), 10 ml.

7. Annotation.

8. Stand for extraction tubes *.

9. Control positive sample of group A streptococcus inactivated, 1 ml **.

10. Control negative sample of group A streptococcus inactivated, 1 ml **.

* Not available in items # 2 and # 5. For sets No. 2 and No. 5, a special hole on the front side of the package is used as a stand for the test tube (you just need to pierce the designated place with a test tube).

** Not available in items # 2 and # 5, available upon request.

Operating principle

STREPTATEST is a sandwich-based membrane immunochromatographic test.

Antibody to group A streptococcus antigen is fixed in the tested area of \u200b\u200bthe membrane. The second antibody to the group A streptococcus antigen combines with the purple latex particles and is placed above the immersion zone of the membrane. Pre-specific antigen of group A streptococcus is extracted from the smear using extraction reagents.

The bottom of the test strip is then dipped into the extraction solution. The specific antigen of group A streptococcus binds to an antibody labeled with latex particles. The mixture moves through the chromatographic system along the membrane, and the complex is fixed in the test zone.

The appearance of a purple band in this area indicates a positive result, while its absence indicates a negative result. The presence of a magenta band in the control zone means that the test was performed correctly. The absence of this band indicates the inadequacy of the test and incorrect analysis.

Analysis procedure

1.Using a tongue holder, press down on the tongue so that saliva does not get on the special tampon. Take a swab from the tonsils, pharynx and all inflamed, ulcerative or exudative areas.

2. It is recommended that the test be performed immediately after taking a smear. If this cannot be done immediately, swab specimens can be stored for 4 hours at room temperature (15–30 ° C) in a dry, sterile and hermetically sealed container, or for 24 hours in a refrigerator (2–8 ° C). If another culture needs to be tested at the same time, a new swab should be used.

3. Remove the test strip from the bag just before testing.

4. Pour 4 drops of pink extraction reagent A into an extraction tube and add 4 drops of colorless extraction reagent B there. Shake the tube slightly to mix the two solutions. The mixture will change color from pink to colorless.

5. Dip the swab into the test tube. Twist the swab about 10 times in the extraction solution. Leave it on for 1 min.

6. Squeeze the swab against the sides of the tube to remove any excess liquid. Throw away the tampon.

7. Place the test strip in the extraction tube with the arrows pointing towards the extraction solution. Leave the test strip in the vial.

8. After 5 minutes the result can be read.

If the concentration of the infectious agent is high, then a positive result may appear in the first minute. However, to be sure of a negative result, you must wait 5 minutes.

Do not take into account the result obtained after 10 minutes.

results

Positive: the control and test zones display two magenta colored bars.

Negative: only one magenta bar is displayed in the control zone.

Note. If no streaks appear in the control and test zones, then the analysis was performed incorrectly. It is necessary to repeat the procedure again.

Quality control

Internal control

The control strip is used for internal control of the correct functioning of the test strip and reagents.

External control

1. Pour 4 drops of reagent A and 4 drops of reagent B into an extraction tube. Mix well.

2. Add a drop of the control positive or negative sample to the test tube.

3. Immerse a clean swab in a test tube and perform all test operations, as for taking a throat swab. It is recommended that positive and negative control samples be tested each time a new lot of kits is received and when the user changes. Also, if in doubt about the reliability of the tests performed (storage, the testing process itself), it is recommended to check the control samples. If the results of the control tests carried out do not correspond to the declared ones, you should contact the company representatives Dectra Pharm.

Specifications

1. The quality of the test depends on the quality of the sample taken. A false negative result can be due to a poor sample or improper swab storage. A negative result can also be obtained in patients who are at the initial stage of the disease and have an insufficient concentration of antigens. Therefore, if a group A streptococcus infection is suspected and a negative test result, a new smear should be taken and tested using conventional culture methods.

2. Use the swabs supplied in the kit.

3. In rare cases, samples with large quantities Staphylococcus aureus can give false positive results. If clinical signs are not consistent with test results, conventional bacteriological testing is recommended.

4. Respiratory infections, such as pharyngitis, can be caused by streptococcus other than serogroup A, as well as other pathogens.

5. STREPTATEST does not allow quantitative assessment of group A streptococcus concentration.

6. As with any diagnosis in vitro, the clinical diagnosis should be based not only on the test results, but also on the conclusion of a specialist made after all clinical and biological studies.

pharmachologic effect

Precautionary measures

As extraction reagents A and B pose a potential hazard, in case of improper use and / or ingestion, consult a doctor immediately.

Close the jars with reagents A and B immediately after use and keep them out of the reach of patients.

Inform patients about the possible risks of reagents A and B. Do not use after the expiration date. Do not change the lids of reagent jars (samples can be contaminated with infectious agents).

Material in direct contact with samples is considered contaminated. The instructions must be followed, taking precautions. The product is intended solely for diagnostics in vitro!

special instructions

As a result of a comparative study conducted with the participation of 525 patients with symptoms of sore throat or pharyngitis, it was found that the sensitivity threshold of the STREPTATEST test varies depending on the study and the strains analyzed. Its range is 5 × 10 3 bacteria / test to 5 × 10 5 bacteria / test.

STREPTATEST test sensitivity threshold

Accuracy

Int-test accuracy was confirmed on the basis of 15 replications using 3 samples: negative, weak positive and high positive. All 3 samples were correctly identified 99% of the time.

Intertest Accuracy was confirmed on the basis of 15 independent studies of 3 samples (negative, weak positive and high positive). 3 sets of STREPTATEST were used. All samples were correctly identified 99% of the time.

Rapid test for the diagnosis of group A streptococcus No. 2

Composition

• 2, 5 or 20 aluminum foil bags with test strips, bag with desiccant;
• 2, 5 or 20 CE marked swabs
• 2, 5 or 20 extraction tubes;
• 2, 5 or 20 tongue depressors individually wrapped with CE marking;
• Control positive sample of group A streptococcus inactivated -1 ml
  ;
• Control negative sample of group A streptococcus inactivated -1 ml
  (not available in sets # 2 and # 5);
• A jar with an extracting reagent A (sodium nitrite 2M) - 10 ml;
• A jar with an extracting reagent B (acetic acid 0.4 M) -10 ml;
• Annotation;
• Stand for extraction tubes (not available in sets # 2 and # 5).

Description

It takes 24 to 48 hours to identify and identify the pathogen using traditional methods. But the methods of immunochromatography today make it possible to directly detect the specific antigen of group A streptococcus with a single smear, which in turn allows the doctor to immediately diagnose and prescribe the necessary course of treatment.

Precautionary measures

Since extracting reagents A and B pose a potential hazard, in case of improper use and / or contact with the skin, in the eyes, immediately rinse the damaged area with plenty of water, if reagent A is swallowed, provoke vomiting, then drink plenty of fluids; if reagent B is swallowed, rinse out mouth, then drink plenty of fluids.

In all these cases, consult a doctor.

Close the jars of reagents A and B immediately after use, keep them out of the reach of patients.

Do not replace reagent bottle caps.

Samples can be contaminated with infectious agents. Material in direct contact with samples is considered contaminated. Follow the instructions, taking precautions.

For in vitro diagnostic use only! Do not reuse!

Method of administration and dosage

• Use a tongue holder to press down on your tongue to prevent saliva from getting on the special swab. Take a swab from the tonsils, throat and any inflamed, ulcerative, or exudative areas.
• It is recommended that the test be performed immediately after taking a smear. If it cannot be done immediately, swab samples can be stored for 4 hours at room temperature (15 ° C-30 ° C) in a dry, sterile and hermetically sealed container, or for 24 hours in a refrigerator (2 ° C-8 ° C ). If you need to test another culture at the same time, use a new swab.
• Remove the test strip from the bag immediately before testing.
• Pour 4 drops of pink extraction reagent A into an extraction tube and add 4 drops of colorless extraction reagent B. Shake the tube slightly to mix the two solutions. The mixture will change color from pink to colorless.
• Dip the swab into the tube. Rotate the swab in the extraction solution about 10 times. Leave it on for one minute.
• Squeeze the swab against the sides of the tube to remove any excess liquid. Discard the swab.
• Place the test strip in the extraction tube with the arrows pointing towards the extraction solution. Leave the test strip in the vial.
• After 5 minutes, you can evaluate the result. If the concentration of the infectious agent is high, then a positive result may appear in the first minute. However, to be sure of a negative result, you must wait 5 minutes. Disregard the result after 10 minutes.

Results:

Positive: Control and test areas display two magenta colored bars

Negative: only one magenta band is displayed in the control zone

Note: if no bands appear in the control and test zones, then the analysis was performed incorrectly. It is necessary to repeat the procedure again

Shelf life

All items included in the kit must be stored at room temperature or in the refrigerator (2 ° C to 30 ° C). Do not freeze.

Do not use the kit after the expiration date printed on the package. Expiration date 24 months.

The information presented on the site should not be used for self-diagnosis and treatment and cannot serve as a substitute for an in-person consultation with a doctor.

All items included in the kit must be stored at room temperature or in the refrigerator (2 ° C to 30 ° C). Do not freeze. Do not use the kit after the expiration date printed on the package.

Method of application (description)

Analysis procedure
1.Using a tongue holder, press down on the tongue so that saliva does not get on the special tampon. Take a swab from the tonsils, pharynx and all inflamed, ulcerative or exudative areas.
2. It is recommended that the test be performed immediately after taking a smear. If this cannot be done immediately, swab specimens can be stored for 4 hours at room temperature (15–30 ° C) in a dry, sterile and hermetically sealed container, or for 24 hours in a refrigerator (2–8 ° C). If another culture needs to be tested at the same time, a new swab should be used.
3. Remove the test strip from the bag just before testing.
4. Pour 4 drops of pink extraction reagent A into an extraction tube and add 4 drops of colorless extraction reagent B there. Shake the tube slightly to mix the two solutions. The mixture will change color from pink to colorless.
5. Dip the swab into the test tube. Twist the swab about 10 times in the extraction solution. Leave it on for 1 min.
6. Squeeze the swab against the sides of the tube to remove any excess liquid. Throw away the tampon.
7. Place the test strip in the extraction tube with the arrows pointing towards the extraction solution. Leave the test strip in the vial.
8. After 5 minutes the result can be read.
If the concentration of the infectious agent is high, then a positive result may appear in the first minute. However, to be sure of a negative result, you must wait 5 minutes.
Do not take into account the result obtained after 10 minutes.

Features (description)

Release form

Streptatest is a membrane-based immunochromatographic test that works according to the sandwich principle.

Expiry date from the date of manufacture

Product description

Streptotest is a universal express test for a doctor and patient, which allows diagnosing the presence or absence of a dangerous beta-hemolytic group A streptococcus in the throat within 5 minutes. the most important thing is to prevent the development of the most serious complications!

Indications for use

With inflammation of the mucous membrane and lymphoid tissue of the pharynx. If you suspect a sore throat, pharyngitis, scarlet fever.

special instructions

Positive: The control and test zones show two magenta colored bars.
Negative: Only one magenta bar is displayed in the control zone.
Note. If no streaks appear in the control and test zones, then the analysis was performed incorrectly. It is necessary to repeat the procedure again.

With care (Precautions)

Since extracting reagents A and B pose a potential hazard, in case of improper use and / or contact with the skin, in the eyes, immediately rinse the damaged area with plenty of water, if reagent A is swallowed, provoke vomiting, then drink plenty of fluids; if reagent B is swallowed, rinse out mouth, then drink plenty of fluids.
In all these cases, consult a doctor.
Close the jars of reagents A and B immediately after use, keep them out of the reach of patients.
Do not replace reagent bottle caps.
Samples can be contaminated with infectious agents. Material in direct contact with samples is considered contaminated.
Follow the instructions, taking precautions. For in vitro diagnostic use only! Do not reuse!

Composition

1.2 pack. aluminum foil with test strips, desiccant bag.
2. 2 CE marked swabs.
3. 2 extraction tubes.
4. 2 tongue depressors with "CE" mark.
5. Jar with extracting reagent A (sodium nitrite 2 M), 10 ml.
6. Jar with extracting reagent B (acetic acid 0.4 M), 10 ml.
7. Annotation.

Express test at home:
on streptococcus.

Streptococcus is a genus of gram-positive anaerobic bacteria that lives in the respiratory and digestive tract, and especially in the mouth and nose of humans.

It is he - streptococcus - that is a common cause of occurrence. This bacterium lives on household items, skin and mucous membranes, as well as in the digestive tract.

Getting into the throat with air or poorly processed food, streptococcus begins to destroy healthy cells, which leads to the formation of purulent processes. Streptococcus is especially active against the background of reduced immunity.

This bacterium causes diseases such as scarlet fever, pharyngitis, tonsillitis (sore throat).

Pharyngitis is characterized by a moderate increase in temperature, sore throat and sore throat, as well as a dry and sometimes painful cough. With angina, there is an increase in the tonsils, the formation of purulent foci and an increase in body temperature to high levels. Scarlet fever manifests itself in the same symptoms as sore throat, plus specific grains on the tongue and a rash on the body are also added to them.

In any case, an accurate diagnosis can only be made by a doctor after a complete examination. However, in order to accurately determine the diagnosis and not to miss streptococcal sore throat in the early stages, you can do an express test for streptococcus yourself at home. And already with the test results, consult a doctor.

Firstly, it will save you time and money by eliminating the need to stand in lines at the clinic and spend money on buying unnecessary drugs.

Secondly, according to the test results, the doctor will be able to make an accurate diagnosis and prescribe the appropriate treatment with exactly those drugs that are needed in this case.

"RED streptococcus A" - rapid test for streptococcus.

In medical institutions, bacteriological research is also used to diagnose beta-hemolytic streptococcus A. The only drawback of such an examination in a medical institution is the expectation of the result, which can take several days.

Therefore, in order not to waste time and illness, treatment has to be prescribed here and now, without waiting for the results.

"RED streptococcus A" allows you to confirm or exclude streptococcal infection within 10 minutes. And in case of a negative result, avoid unnecessary use of antibiotics.

Rapid test for streptococcus. How to use?

The rapid streptococcus test is easy to use. The sensitivity of the test is over 99%.

This test kit includes:

• test strips in white plastic cassettes;
• a dropper bottle containing reagent pink A;
• a bottle with a dropper cap containing a colorless reagent B;
• disposable plastic test tube;
• sterile cotton swabs on the probe;
• disposable pipettes;
• adhesive labels for records;
• instructions for use.

Analysis.

1. Add 5 drops of pink reagent A and 5 drops of colorless reagent B to a disposable plastic tube. The solution should turn pale yellow.
2. Using a sterile cotton swab, swab the tonsils and / or the back of the larynx, avoiding contact with the teeth, gums, tongue and cheeks.
3. Place the swab with the sample in the test tube. In order to wash off the sample, the swab must be rotated along the walls of the tube 10 times clockwise and 10 times counterclockwise. Squeeze out the remaining liquid from the swab by pressing it against the walls of the tube. Throw away the tampon.
4. Immediately before the start of the analysis, the package of the RED Streptococcus A test should be opened and placed on a dry, flat, horizontal surface.
5. Using a disposable plastic pipette, add 4 drops of liquid sample into the round window of the cassette marked with the letter S.
6. After 10 minutes, visually assess the result of the reaction.

Interpretation of results.

1. The detection of one BLUE control line in the cassette test window indicates a negative test result. That is, one blue line indicates the absence of group A streptococci cells in the analyzed sample.
2. The detection of two parallel colored lines (BLUE and RED) in the test window of the cassette indicates a positive result of the analysis, i.e. two bands in the test indicate the presence of group A streptococcus cells in the analyzed sample. The intensity of the red analytical line in the test window may vary depending on the concentration of group A streptococcus cells in the sample.
3. If no lines appear in the test window of the cassette or only a red analytical line is formed, the result is considered invalid. If this result, the analysis should be repeated using another test for streptococcus.

Note!

A separate tube, separate pipette and a separate Streptococcus test must be used for each sample. Do not use tests after the expiration date. Disposable medical gloves should be worn during testing. Used tests and residues of biological material should be placed in a special container for sanitary waste.