The Strep B Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of Group B Streptococcus (GBS) antigens in samples taken from vaginal, rectal swaps of pregnant women or diverse swabs from newborn.
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.
• Rapid test cassette with desiccant.
• Sampling Swab
• Reagent 1
• Reagent 2
• Extraction Tube
• Package insert
• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE.
Sample Collection&Storage
1) The quality of specimen obtained is of extreme importance. Collect swab specimens using standard clinical methods.
2) Use only Dacron or Rayon tipped sterile swabs with plastic shafts such as those provided. Do not use calcium alginate, cotton tipped, or wooden shafted swabs.
3) It is recommended that swabs specimens be processed as soon as possible after collection. If swabs are not processed immediately, they should be placed into a sterile, dry, tightly capped tube or bottle and refrigerated. Do not freeze. Swabs can be stored at room temperature up to 4 hours, or refrigerated (2-8°C) up to 24 hours. All specimens should be allowed to reach room
temperature (15-30°C) before testing.
4) If a liquid transport method is desired, use Modified Stuart's Transport Media and follow the manufacture's instructions. Do not place the swab in any transport device containing medium. Transport medium interferes with the assay, and viability of organisms is not required for the assay. Do not use transport media formulas that include charcoal or agar.
5) If a bacteria culture is desired, lightly roll the swab on a appropriate cell culture plate before using it in the test. The extraction reagents in the test will kill bacteria on swabs and make them impossible to culture.
1 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.
1) 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.
2) 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 solution from 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.
About Us
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.
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