Streptococcus B Rapid Test (1 pc/box)

Streptococcus B Rapid Test (1 pc/box)

The Streptococcus B Rapid Test is an immunological assay based on visual detection designed for the qualitative presumptive identification of Group B Streptococcus (GBS) antigens from vaginal or rectal swab samples collected from pregnant women. This kit assists in the diagnosis of Group B Streptococcus infections.

Group B Streptococcus (GBS), also known as Streptococcus agalactiae, is a leading cause of life-threatening neonatal infections. Newborn infection typically occurs during delivery via maternal birth canal colonization but can rarely occur during pregnancy. Early-onset GBS infections in newborns include meningitis, sepsis, pneumonia, and acute respiratory distress syndrome (ARDS).

Approximately 5–30% of pregnant women carry GBS detectable by vaginal or rectal screening. Multiple recent studies have demonstrated that intrapartum antibiotic prophylaxis in GBS-positive women significantly reduces the incidence of neonatal GBS sepsis. The U.S. Centers for Disease Control and Prevention (CDC) recommends routine screening between 35 and 37 weeks of gestation. CDC data indicate routine screening is 50% more effective than antibiotic use based on clinical risk factors alone. This product is intended for professional use only.

Specifications

Product Name: Streptococcus B Rapid Test

Sample Type: Vaginal or rectal swab

Packaging: 1 test/box

Test Format: Cassette

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd., 3rd Floor, Building 4, No. 1418, Moganshan Road, Hangzhou, Zhejiang, 50 China

EC Representative: Lotus NL B.V., Koningin Julianaplein 10, Le Verd, 2595AA, The Hague, Netherlands

Expiry Date: November 2026

Kit Contents

• 1 test cassette

• 1 vial of Reagent 1

• 1 vial of Reagent 2

• 1 positive control

• 1 sterile swab for sample collection

• 1 extraction tube with cap

• 1 instruction manual in English

Test Procedure

Important: Carefully read the instruction manual before performing the test. Collect samples strictly according to the manual. Before use, allow all reagents, devices, and samples to reach room temperature (15°C-30°C).

1. Sample preparation:

1. Add 4 drops of Reagent 1 and 4 drops of Reagent 2 into the extraction tube. Mix gently.

2. Immediately insert the swab into the extraction tube after sample collection. Rotate the swab gently while pressing it against the tube walls to release the sample.

3. Let it stand for 3-5 minutes at room temperature. Press the swab firmly to release as much fluid as possible, then discard the swab according to biohazard regulations.

2. Remove the test cassette from the sealed pouch and place it on a clean, flat surface. Label the test with patient ID or control ID. Perform the test within 1 hour of opening.

3. Add 2 drops (approximately 100 μL) of the extracted sample into the sample well (S) of the cassette. Avoid trapping air bubbles and do not apply sample to the result window. The test starts as the sample migrates across the membrane.

4. Wait for colored lines to appear. Read the result at 10 minutes. Results read after 15 minutes are invalid.

Interpretation of Results

• Positive: Two distinct red lines appear - one at the control line (C) and one at the test line (T). Any visible pink or red test line (T) indicates a positive result.

• Negative: One red line appears at the control line (C). No line appears at the test line (T).

• Invalid: No red line at the control line (C), regardless of test line (T) presence, or no lines at all. This may indicate insufficient sample or incorrect test procedure.

Performance Characteristics

• Relative Sensitivity: 90.9%

• Relative Specificity: 97.9%

• Overall Agreement: 96.7%

Legal Notices

Professional Use

This product is an in vitro diagnostic (IVD) and intended exclusively for professional use by medical personnel. Use for self-testing is not permitted. The manufacturer/distributor accepts no liability for damages resulting from improper or unauthorized use.

Right of Withdrawal

In accordance with § 312g (2) No. 3 of the German Civil Code (BGB), there is no right of withdrawal for sealed goods which, for reasons of health protection or hygiene, are not suitable for return if their seal has been removed after delivery.

Disclaimer

The seller assumes no responsibility for compliance with legal regulations within the buyer’s procurement process. The seller’s responsibility is limited solely to the delivery of the ordered goods and the provision of information regarding their proper use.

Instructions