Streptococcus B Rapid Test (1 pc/box)

• The price includes 5% VAT.

• This product can be ordered for professional use.

Streptococcus B Rapid Test

The Streptococcus B Rapid Test is a visually read immunoassay for the qualitative presumptive detection of group B Streptococcus (GBS) antigens in vaginal or rectal specimens from pregnant women. This kit aids in the diagnosis of group B Streptococcus infection.

Group B Streptococcus (GBS) or Streptococcus agalactiae is one of the most common life-threatening neonatal infections. Infection of the newborn most often occurs during delivery in the birth canal, and less frequently during the mother’s pregnancy. Early-onset neonatal conditions caused by Streptococcus agalactiae include meningitis, sepsis, pneumonia and subsequently ARDS (acute respiratory distress syndrome).

GBS can be detected in specimens from 5-30% of pregnant women. Several recent studies have shown that treating GBS-positive women during labor significantly reduces the incidence of GBS-related sepsis in newborns. The US Center for Disease Control and Prevention (CDC) recommends routine screening for group B Streptococcus between the 35th and 37th weeks of pregnancy. A CDC study has shown that routine screening is 50% more effective than the use of antibiotics in pregnant women with clinical risk factors. This product can be ordered for professional use.

Streptococcus B Rapid Test Specifications

Product name: Streptococcus B Rapid Test
Specimen: vaginal or rectal specimen
Packaging: 1 pc/box
Format: Cassette test
Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3RD FLOOR, BUILDING 4, NO. 1418 - ,MOGANSHAN ROAD, HANGZHOU, ZHEJIANG, 50 CHINA, imd.assuretech@diareagent.com
EC REP: Lotus NL B.V. Koningin Julianaplein 10, le Verd, 2595AA,The Hague,Netherlands, peter@lotusnl.com
Expiry date: 30/11/2026

Contents of the Streptococcus B Rapid Test Kit

• 1 test cassette
• 1 Reagent 1
• 1 Reagent 2
• 1 positive control
• 1 sterile sampling swab
• 1 extraction tube and cap
• 1 instructions for use in Hungarian

Test Procedure

Read the Instructions for Use carefully before performing the test! Collect the specimen as described in the instructions for use.

Before use, allow the devices, reagents, specimens and/or controls to reach room temperature (15°C–30°C).

After specimen collection:

1. Specimen preparation:

1. Add 4 drops of Reagent 1 to the extraction tube, followed by 4 drops of Reagent 2. Gently mix the solution.
2. Immediately after collection, place the swab into the extraction tube. Rotate the swab in a circular motion, then press it against the side of the extraction tube so that the specimen is released from the swab and mixes with the solution.
3. Let it stand for 3-5 minutes at room temperature, then press the swab firmly against the tube to squeeze out as much liquid as possible from the sampling swab. Dispose of the sampling device in accordance with the guidelines for infectious materials.

2. Remove the test from the sealed pouch and place it on a clean, level surface. Label the test with the patient’s name or the control identifier. For best results, the assay should be performed within one hour.

3. Add 2 drops (approximately 100 μL) of the extracted solution from the extraction tube to the specimen well of the test device. Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window. As the test begins to work, color will migrate across the membrane.

4. Wait for the colored line(s) to appear. The result should be read at 10 minutes; after 15 minutes the test is considered invalid.

Interpretation of Results

Positive

Two distinct red lines appear. One line appears in the control region (C) and the other line appears in the test region (T). A line in the test region (T) with a color between pink and red, however faint, indicates a positive result.

Negative

One red line appears in the control region (C). No line appears in the test region (T).

Invalid

Only one red line appears in the test region (T) and no red line appears in the control region (C). / No red line appears at all. The most likely causes: insufficient specimen volume or incorrect use of the device.

Performance of the Streptococcus B Rapid Test

• Relative sensitivity: 90.9%
• Relative specificity: 97.9%
• Overall agreement: 96.7%

The test may only be used by qualified professionals and healthcare workers! Carbon Web Kft. accepts no liability for use for self-testing purposes.

ATTENTION!
Under Hungarian Government Decree 45/2014 (II. 26.), for health protection or hygiene reasons this product cannot be returned after delivery; therefore the 14-day right of return does not apply to this product. Section 29 (1) The consumer may not exercise the right under Section 20 (the consumer’s right of withdrawal) in respect of (e) a product in sealed packaging which, for health protection or hygiene reasons, cannot be returned after it has been opened following delivery.

Carbon Web Kft. is not responsible for fulfilling the legal obligations related to the Buyer’s procurement procedure, as this falls within the Buyer’s competence; its responsibility is limited exclusively to information on intended use and to the goods delivered.