High sensitivity rapid test for the qualitative detection of Group B Streptococci (GBS) in urine CE certified
Applications:
The Strep B Rapid Test Cassette (Swab) is a rapid visual immunoassay for the qualitative, presumptive detection of Group B Streptococcus (GBS) antigens in specimens taken from vaginal or rectal swabs of pregnant women, or general swabs from newborn. This kit is intended for use as an aid in the diagnosis of Strep B infection.
Description:
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. Several recent studies have shown that the intrapartum treatment of GBS-colonized women significantly reduces the incidence of GBS-caused sepsis. 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.
How to use?
FOR CASSETTE USE
Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test cassette 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 240 μl) 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 160 μl) 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. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4.
6. Add 3 full drops of the extracted solution (approx. 150μl) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well. Wait for the color 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.
FOR DIPSTICK 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.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:*Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T). A positive result indicates that Strep B was detected in the specimen.
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of Strep B present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A negative result indicates that Strep B antigen is not present in the specimen, or is present below the detectable level of the test.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
