STREP A
Lab-On-TimeTM Strep A is a rapid throat swab test device.
An integrated rapid test device for throat specimen collection and qualitative detection of Streptococcus A antigens. For professional in vitro diagnostic use only.

It is an integrated rapid test device for the collection of throat specimens and the qualitative detection of Streptococcus A antigens for professional in vitro diagnostic use only.

Streptococcus pyogenes is a gram-positive, non-motile coccus containing Lancefield's group A antigens that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis and arthritis.
1 These untreated infections can lead to serious complications such as rheumatic fever and peritonsillar abscess.
2 Traditional identification procedures for Group A Streptococcal infection involve the isolation and identification of viable organisms using techniques requiring 24 to 48 hours or more.
The Lab-on-TimeTM Strep A Rapid Test Device is an integrated device for the collection of throat swab specimens and rapid qualitative analysis to detect the presence of Strep A antigen and provide results in less than 5 minutes. The test uses antibodies specific to Lancefield's Group A Streptococcus to selectively detect Strep A antigens in a throat specimen.

USE
The Lab-on-TimeTM Strep A Rapid Test Device is an integrated device for the collection of a throat swab specimen and its rapid analysis by chromatographic immunoassay for the qualitative detection of Strep A antigen to aid in the diagnosis of Group A Streptococcal infection.
PRINCIPLE
PRECAUTIONS
REACTIVE
The test contains particles coated with anti-Strep A antibodies and anti-Strep A antibodies coated on the membrane.

PRECAUTIONS
1. For professional in vitro diagnostic use only. Do not use after the expiration date.
2. Do not eat, drink or smoke in the area where specimens and kits are handled.
3. Handle all specimens as if they contain infectious agents. Follow established precautions against microbiological hazards throughout the procedure and follow standard procedures for proper specimen disposal.
4. Wear protective clothing such as lab coats, disposable gloves, and safety glasses when analyzing specimens.
5. The test used must be disposed of in accordance with local regulations.
6. Humidity and temperature may affect results.
7. Do not use the test if the pouch is damaged.
8. The Positive and Negative Controls contain sodium azide (NaN3) as a preservative.
9. Do not change the caps on the External Control Solution bottles.

STORAGE AND STABILITY :
Store the product in its sealed package at room temperature or in the refrigerator (between 2 and 30 ° C). The test is stable until the expiry date printed on the sealed pouch. The test must remain in the sealed pouch until use. NE
NOT FREEZE. Do not use after the expiration date.

SAMPLING AND PREPARATION OF SAMPLES:
1. Collect the throat swab with the sterile Strep Lab-on-TimeTM Streptococcal Rapid Test Device provided in the kit. Remove the cap from the device and use the swab tip from the device to rub the posterior pharynx, tonsils and other inflamed areas. Avoid touching your tongue, cheeks, and teeth with the tip (T-Strep cotton swab).
2. Tests should be performed immediately after specimen collection.
3. If culture is desired, lightly swab the tip (of the cotton swab) on Group A Selective Blood Agar (GAS) before performing the rapid test using the test reagent tube provided.

MATERIALS :
Materials Provided
- Rapid test device Strep A
- Extraction tube with extraction reagent (sodium nitrite 1.2 M)

INSTRUCTIONS FOR USE :
Allow the test, reagents, throat swab and/or controls to reach room temperature (15-30°C) before testing.
1. Remove the Strep A Rapid Test Device from the sealed foil pouch and use as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. 2. Remove the extraction tube containing the extraction reagent from the second sealed foil pouch.
3. Insert the Strep A Rapid Test Device containing the patient throat specimen into the extraction test tube with the tip of the swab dipped into the extraction buffer. Shake the Strep A Rapid Test Device by rotating it at least 10 times to obtain effective Strep A antigen extraction. Leave the Strep A rapid test in the extraction specimen and wait for the coloured line(s) to appear. Read the result in the results window of the Strep A Rapid Test Device within 5-10 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS :
(Please refer to the illustration above)
POSITIVE: two lines appear * A colored line should appear in the region of the control line (C) and another line of apparent color in the region of the test line (T).
A positive result indicates that Streptococcus A has been detected in the specimen.
* NOTE: The intensity of the color in the Test Line (T) region varies with the concentration of Strep A present in the specimen. Therefore, any shade of color in the test line (T) region should be considered positive.
NEGATIVE: A colored line appears in the Control Line (C) region. No line appears in the region of the test line (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 specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms do not agree with the results, obtain another specimen for culture.
INVALID: The control line does not display. Insufficient specimen volume or incorrect procedural techniques are the most likely causes of control line failure. Review the procedure and repeat the test with a new test. If the problem persists, stop using the test kit immediately and contact your local distributor.

QUALITY CONTROL :
Internal Quality Control
Internal procedural controls are included in the test. A colored line appearing in the control region (C) is a positive internal procedural control. It confirms that the sample volume is sufficient, the membrane absorbs properly, and the procedure is correct.
External Quality Control
It is recommended that a positive and negative external control be performed every 25 tests, according to internal laboratory procedures. Positive and negative external controls are provided in the kit. Alternatively, other reference strains of Group A Streptococcus and Group A Streptococcus can be used as external controls. Some commercial controls may contain interfering preservatives; therefore, other commercial controls are not recommended.
External Quality Control Testing Procedure
1. Add one drop of Positive or Negative Control Solution to the extraction tube containing the Extraction Reagent, holding the vial upright.
2. Place the Strep A Rapid Test Device in this extraction tube and shake it in the solution by rotating it at least 10 times.
3. Continue with step 3 of the Instructions for Use. If the controls do not give the expected results, do not use the test results.
Repeat the test or contact your distributor.

LIMITS:
1. The Strep A Rapid Test Device is intended for in vitro diagnostic use only. The test is to be used for the detection of Strep A antigen in throat swab specimens only. This qualitative test does not determine the quantitative value or rate of increase of Strep A antigen concentration.
2. This test will only indicate the presence of Strep A antigen in the specimen from viable and non-viable Group A Streptococcus bacteria.
3. A negative result should be confirmed by culture. A negative result may be obtained if the concentration of Strep A antigen present in the throat swab is not adequate or is below the detectable level of the test.
4. Excess blood or mucus on the specimen may interfere with the performance of the test and may give a false positive result. When collecting specimens, avoid touching the tongue, cheeks and teeth and avoiding bleeding from the mouth with the Strep A Rapid Test Device.
5. As with all diagnostic tests, all results should be interpreted in conjunction with other clinical information available to the physician.

EXPECTED VALUES :
Approximately 15% of pharyngitis in children 3 months to 5 years of age is caused by Group A beta-hemolytic streptococcus.
6. In school-aged children and adults, the incidence of streptococcal throat infection is approximately 40%.
7. This disease usually occurs in winter and early spring in temperate climates.

PERFORMANCE CHARACTERISTICS :
Sensitivity and Specificity
Using three medical centres for evaluation, a total of 526 throat swabs were collected from patients with symptoms of pharyngitis. Each swab was rolled onto a sheep blood agar plate and tested by the
Strep A rapid test strip (throat swab). The plates were then streaked for isolation and incubated at 37°C with 5-10% CO2 and a bacitracin disc for 18-24 hours. Negative culture plates were incubated for a further 18-24 hours. Possible GAS colonies were subcultured and confirmed with a commercially available latex agglutination kit. Of the 526 total samples, 404 were confirmed negative and 122 confirmed positive by culture.