Rapid test kit Strep B - BMT 51087

 

Contents :

Rapid single-step Strep B test for the qualitative detection of Strep B antigen in samples taken from vaginal or rectal swabs of pregnant women or general swabs of the newborn. For professional in vitro diagnostic use only.

 

INTENDED APPLICATION

The Strep B Rapid Test Kit is a rapid visual immunoassay for the qualitative detection of Group B Streptococcal (GBS) antigens in vaginal or rectal swab specimens from pregnant women or newborns. This kit is intended for use as an aid in the diagnosis of Streptococcal B infection.

 

SUMMARY

Group B Streptococcus (GBS) or Streptococcus agalactiae are among the most common causes of life-threatening infection in newborns. Between 5% and 30% of pregnant women are colonized with GBS.1 Several recent studies have shown that intrapartum treatment of women colonized with GBS significantly reduces the incidence of Sepsis caused by GBS.2-4 The US Center for Disease Control and Prevention (CDC) recommends routine testing for group B streptococcus between 35 and 37 weeks of pregnancy. A CDC study showed that routine testing is 50% more effective than antibiotic use for pregnant women with clinical risk factors.

Standard culture methods require 24 to 48 hours and results may not be available early enough for effective treatment. Thus, methods using more rapid screening techniques are needed.

 

PRINCIPLE

The Strep B Rapid Test Kit detects Group B Streptococcal antigens by visual interpretation of colour development on the rapid test strip. Anti-Strep B antibodies are immobilized on the test area of the membrane. During testing, the specimen reacts with polyclonal anti-Strep B antibodies conjugated to colored particles and pre-coated on the test specimen pad. The mixture then migrates through the capillary membrane and interacts with the reagents on the membrane. If there is sufficient Strep Antigen B in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band in the control region serves as a procedural control, indicating that an appropriate volume of specimen has been added and a membrane strand has occurred.

 

REACTIVE

The test consists of an extraction tube containing an extraction reagent (sodium nitrite solution), a sterile proprietary swab impregnated with an acidification reagent and a test strip bearing particles coated with Strep B antibodies and membrane covering antibodies.

 

PRECAUTIONS

- For professional in vitro diagnostic use only.

- Do not use after the expiry date indicated on the packaging. Do not use the test if the foil pouch is damaged. Do not reuse the test.

 

- This kit contains products of animal origin. Certified knowledge of the origin and/or health status of the animals does not fully guarantee the absence of transmissible pathogens. It is therefore recommended that these products be treated as potentially infectious and handled according to normal safety rules (e.g. do not ingest or inhale). -•

Avoid cross-contamination of samples by using a new extraction tube for each specimen obtained.

- Read the entire procedure carefully before testing.

- Do not eat, drink, or smoke in the areas where samples and kits are handled... .

Handle all specimens as if they contain infectious agents. Observe microbiological precautions throughout the procedure and follow standard procedures for proper specimen disposal. Wear protective clothing such as lab coats, disposable gloves, and eye protection when specimens are analyzed.

Use only the proprietary swabs provided with this kit. Do not use any other commercially available swabs, including (but not limited to): calcium alginate, cotton-tipped swabs or wooden swabs.

Avoid contact of the extraction reagent with eyes or mucous membranes. In the event of accidental contact, rinse thoroughly with water .

Humidity and temperature may affect results.

 

 

STORAGE AND STABILITY

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).

The test is stable until the expiry date printed on the sealed pouch. The test and swab must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiry date.

 

SAMPLE COLLECTION AND PREPARATION

1. The quality of the specimen obtained is of the utmost importance. Collect swab specimens using standard clinical methods.

2. Use only the proprietary swabs supplied with this kit. Do not use any other commercially available swabs, including (but not limited to) calcium alginate, cotton tips or wooden swabs.

3. 3. Swab samples should be processed immediately after collection.

 

MATERIALS

Material supplied

Extraction tube with extraction reagent - Packing instructions

- Strep B Test Strip - Workstation

- Exclusive Strep B swab Material required but not supplied

- Timer

 

INSTRUCTIONS FOR USE

Allow the assay, reagents, sample and/or controls to reach room temperature (15-30°C) before testing.

1. Remove the test strip from the sealed foil pouch and use as soon as possible. Best results will be obtained if testing is performed immediately after opening the pouch.

2. 2. Remove the cap from the extraction tube.

3. Collect a vaginal specimen or bacteria from the culture using a BMT swab using the Strep B swab only. No other swab should be used to collect bacterial samples with this kit.

4. Immediately insert the specimen swab into the tube containing the reagent. Good. Mix the swab by rotating it at least 15 times, leaving the swab in the test tube for 1 minute.

5. Press the swab against the side of the tube while removing the swab so that most of the liquid remains in the tube. Discard the swab.

6. Insert the Strep B Test Strip into the extraction tube and wait for the colored line(s) to appear.

7. Read the result in the Strep B rapid test strip at 10 minutes. Do not interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE: * Two lines appear. One colored line must be in the area of the control line (C) and another line of apparent color must be in the area of the test line (T). The result indicates that Strep B has been detected in the sample.

 

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

NEGATIVE: A colored line will appear in the Control Line (C) area. No line appears in the test line region (T). A negative result indicates that Strep B antigen is not present in the specimen, or is present below the detectable level of the test.

 

INVALID: the control line is not displayed. Insufficient or incorrect sample volume Procedural techniques are the most likely causes of control line failure. Review the procedure and repeat the test with a new kit. If the problem persists, stop using the test kit immediately and contact your local distributor.

 

LIMITS

1. The Strep B Rapid Test Kit is intended for professional in vitro diagnostic use and should only be used for the qualitative detection of group B Streptococcus. No significance should be inferred from the intensity or width of the colours of any apparent band. 

2. The accuracy of the test depends on the quality of the swab sample. False negatives may result from improper collection or storage of samples. Negative results may also be obtained from patients in early stages of disease due to low antigen concentration. 

3. The test does not differentiate between asymptomatic Group B Streptococcal carriers and infected patients. If the clinical signs and symptoms do not match those of the laboratory test result, follow-up cell culture is recommended.

4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should be made by the physician only after all clinical examinations and laboratory results have been evaluated.

 

 

PERFORMANCE SPECIFICATIONS

Clinical Study

The Strep B rapid test kit was evaluated with samples from patients in STD clinics. Culture is used as the reference method for the Strep B rapid test kit.

Specimens were considered positive if the culture indicated a positive result.

Specimens were considered negative if the culture indicated a negative result.

Method Culture Total

Strep B results

Quick test

Kit

Positive negative results

 

Positive 100 8108

Negative 5,350,355

Total results 105358463

Relative sensitivity: 95.1% (95% CI: * 89.6% -98.2%)

Relative specificity: 97.8% (CI 95%: * 95.8% -99.0%)

Overall accuracy: 97.1% (95% CI: * 95.3% -98.4%) * Confidence intervals

Cross-reactivity

Intra / Inter-trial

Intra-series and inter-series accuracy was determined with three different production batches using Strep B negative; low, medium and high positive specimens.

Ten replicates of each level were tested each day for 3 consecutive days. The specimens were correctly identified 99% of the time.

Cross-reactivity

Cross-reactivity with other organisms was investigated using suspensions of 107 Colony Forming Units (CFU)/test. The following organisms were negative when tested with the Strep B Rapid Test Kit:

Acinetobacter calcoaceticus Pseudomona aeruginosa Proteus mirabilis

Acinetobacter spp Gardnerella vaginalis Chlamydia trachomatis

Enterococcus faecalis Salmonella choleraesuis Group A / C Streptococcus

Enterococcus faecium Candida albicans Hemophilus influenzae

Staphylococcus aureus Proteus vulgaris Klebsiella pneumoniae

【BIBLIOGRAPHIE】

1. Finch, R.G., French, G.L., and Phillips, I.; Group B Streptococcus in the female genitalia.

leaflet; Br. Med. J., 1 (6020) 1245-1247, 1976

2. You, M.D., Mason, E.O., Leeds, L.J., Thompson, P.K., Clark, D.J. and Gardner, S.E.;

Ampicillin prevents intrapartum transmission of group B streptococcus; JAMA 241 (12) 1245 to 1247, 1979.

3. Boyer, K.M., and Gotoff, S.P.; Prevention of the early neonatal B group.

streptococcal disease with selective intrapartum chemotaxis; N. Eng. J. Med. 314

1665-1669, 1986

4. Lim, D.V., Morales, W.J., Walsh, W.J. and Kazanis, D.; Reducing morbidity and mortality of neonatal group B streptococcus by early diagnosis and chemoprophylaxis; J. Clin. Microbiol. 23,489-492, 1986.

Effective date: 2019-11-27

Cat Number: BMT-51087

- Extraction tube with extraction reagent - Packing instructions

- Strep B Test Strip - Workstation

- Exclusive Strep B Swab

Symbol Index

Caution, see instructions for use Tests per kit