【SUMMARY】
Group B Streptococci (GBS) or Streptococcus agalactiae are among the most frequent causes of life-threatening infections in neonates. Between 5% and 30% of all pregnant women are colonized with GBS. 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 35 th and the 37 th 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.

【DIRECTIONS FOR USE 】
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test dipstick from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240μL) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in color. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160μL) of reagent 2 to the tube. Extraction Reagent 2 is colorless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the color of the solution
from red to yellow. See illustration 1.
3. Immediately insert the swab into the extraction tube, agitate the swab vigorously 15 times, Leave the swab in the extraction test tube for 2 minutes. See illustration 2.
4. Press the swab against the side of the tube and squeeze the bottom of the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab. See illustration 3.
5. With arrows pointing down, place the dipstick into the tube of solution and then start the timer. If the procedure is followed correctly, the liquid should be below the maximum line (MAX) on the test dipstick. See the illustration 4.
6. Wait for the colored line(s) to appear. Read the result at 10 minutes. Do not interpret the result after 20 minutes. See illustration 5.
Note: It is suggested not to use the extraction reagents, beyond 30 days after opening the vial.

 

 

 

Cat. No.	Product Description	Specimen	Format	Kit Size	Cut-Off	Status
ISB-501	Strep B Rapid Test Dipstick	Swab	Dipstick	25 T	See Insert	CE