Strep B Rapid Test

Intended Use

Strep B Rapid Test (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 newborn. Strep B Rapid Test is intended for use as an aid in the diagnosis of Strep B infection.

Introduction

Group B Streptococci (GBS) or Streptococcus agalactiae are among the most frequent causes of life-threatening infectious in neonates. Between 5% and 30% of all pregnant women are colonized with GBS.1 Several recent studies have shown that the intrapartum treatment of GBS-colonized women significantly reduces the incidence of GBS-caused sepsis. 2-4 The US Center for Disease Control and Prevention (CDC) recommends routine examination for Group B streptococcus between the 35th and the 37th week of pregnancy. A CDC study has shown that routine examinations is 50% more effective than the use of antibiotics for pregnant women with clinical risk factors.

Standard culture methods require 24 to 48 hours, and the results may not be available soon enough for efficient treatment. Thus, methods utilizing more rapid screening techniques are required.

Materials

● Individuallypacked test devices

● Reagent 1

● Reagent 2

● Positive control

● Sterilized swabs

● Extraction tubes& tips

● Workstation

● Package insert

Procedure

Bring tests, specimens, reagents and/or controls to room temperature (15-30°C) before use.

1. Prepare swab specimens:

● Place a clean extraction tube in the designated area of the workstation. Add 4 drops of reagent 1 to the extraction tube, then add 4 drops of reagent 2. Mix the solution by gently swirling the extraction tube.

● Immediately immerse the swab into the extraction tube. Use a circular motion to roll the swab against the side of the extraction tube so that the liquid is expressed from the swab and can reabsorb.

● Let stand for 3-5 minutes at room temperature, then squeeze the swab firmly against the tube to expel as much liquid as possible from the swab. Cap the extraction tube with the attached dropper tip. Discard the swab following guidelines for handling infectious agents.

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

3. Add 2 drops (approximately 100 µL) of extracted solutionfrom the extraction tube to the sample well on the test device.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the observation window.

As the test begins to work, color will migrate across the membrane.

4. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 15 minutes.

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