Name: Strep B Rapid Test Device (Swab) - Niche Healthcare
SKU: NH-31187 - SC3948422

Strep B Rapid Test Device (Swab)

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Model Number: NH-31187

Brand: Niche Healthcare

The Strep B Rapid Test Device (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group B Streptococcus (GBS) antigens in specimens taken from vaginal or rectal swaps of pregnant women, or general swabs from new-born. This kit is intended for use as an aid in the diagnosis of Strep B infection.

Description

Qualitative detection of Group B Streptococcus (GBS) antigens in vaginal or rectal swab specimens. Intended for use in pregnant women and new-borns to aid in the diagnosis of GBS infections.

Test Format:
Cassette or dipstick format

Sample Type:
Vaginal or rectal swab

Test Time:
Approximately 10 minutes

Storage Conditions:
Store at room temperature (15–30°C). Do not freeze.

Shelf Life:
Typically 24 months from the manufacturing date.

Performance Characteristics:

Relative Sensitivity: 95.2%–97.4%
Relative Specificity: 97.8%–98%
Analytical Sensitivity: 4500 KbE/ml
Accuracy: 97.2%

Cross-Reactivity:
No cross-reactivity with Group A Streptococcus, Campylobacter species, or E. coli.

Components Included:

Test cassettes or strips
Sterile swabs
Extraction buffer/reagents
Dropper tips
Instructions for use

Instructions for Use

Specimen Collection:

Collect a vaginal swab from the vaginal introitus, followed by a rectal swab using the same swab or two different swabs.
Use only Dacron or Rayon-tipped sterile swabs with plastic shafts. Do not use cotton-tipped, calcium alginate, or wooden shafted swabs.

Specimen Preparation:

Add 12 drops of extraction buffer to the extraction tube.
Insert the swab into the tube and agitate vigorously for 15 seconds.
Leave the swab in the tube at room temperature for 10 minutes.
After incubation, remove the swab, pressing it against the side of the tube to expel as much liquid as possible. Discard the swab.
Mix the solution gently.

Test Procedure:

Remove the test device from its sealed pouch and place it on a clean, level surface.
Using the dropper provided, add 3 drops (approximately 120 µL) of the extracted solution to the sample well on the test device.
Wait for the colored band(s) to appear.
Interpret the result at 10 minutes. Do not interpret the result after 15 minutes.

Interpretation of Results:

Positive: Two colored bands appear—one in the control region (C) and another in the test region (T).
Negative: Only one colored band appears in the control region (C). No band appears in the test region (T).
Invalid: No colored band appears in the control region (C).

Warnings and Precautions:

For in vitro diagnostic use only.
Do not eat or smoke while handling specimens.
Wear protective gloves while handling specimens. Wash hands thoroughly afterward.
Avoid splashing or aerosol formation.
Clean up spills thoroughly using an appropriate disinfectant.
Dispose of all specimens and materials as if they were infectious waste.
Do not use the test kit if the pouch is damaged or the seal is broken.

Please ensure that these details align with your specific product’s specifications. If you require further assistance or customization of these documents, feel free to ask.

Authoritative Links for SEO

Australian Therapeutic Goods Administration (TGA)
For regulatory info on IVDs and medical devices in Australia
https://www.tga.gov.au/medical-devices
https://www.tga.gov.au/in-vitro-diagnostic-ivd-medical-devices
Centers for Disease Control and Prevention (CDC)
Comprehensive info on Group B Streptococcus, screening guidelines, and testing
https://www.cdc.gov/groupbstrep/index.html
https://www.cdc.gov/groupbstrep/about/testing.html
World Health Organization (WHO)
Global health info about Group B Streptococcus and maternal/neonatal health
https://www.who.int/news-room/fact-sheets/detail/group-b-streptococcus
National Institutes of Health (NIH) – MedlinePlus
Patient-friendly info about Group B Strep infection
https://medlineplus.gov/groupbstrep.html
European Medicines Agency (EMA)
Regulatory overview of IVD devices in the EU (comparable to TGA regulation)
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices-in-vitro-diagnostics
Clinical & Laboratory Standards Institute (CLSI)
Standards for diagnostic tests and quality control (subscription required)
https://clsi.org/standards/products/microbiology/documents/m100/