20 individually packed test cassettes for detection of group B Streptococcus (GBS) antigens in specimens collected from vaginal or rectal swab.
Package contents:
20 test cassettes
20 disposable pipettes
20 sterilized swabs
1 bottle Reagent 1
1 bottle Reagent 2
1 Positive Control
1 Negative Control
20 extraction tubes
1 reagent holder
1 package insert
Exclusively for professional users
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The NADAL® Strep B Test is a rapid, visual immunoassay for the qualitative, presumptive detection of group B Streptococcus (GBS) antigens in specimens collected from vaginal or rectal swab. Ear or throat swabs from newborns collected directly after birth can also be used. The test is intended as an aid in diagnosing the presence of GBS in sample material that may either be a sign of colonisation or infection. This test provides epidemiological information about infections caused by GBS. The NADAL® Strep B Test is designed for professional use only. The detection limit of the assay is 1x105 bacteria/swab and does not depend on viability of organisms.
Group B Streptococci (GBS) or Streptococcus agalactiae are among the most frequent causes of life-threatening infections in neonates. Up to 30% of all pregnant women are colonised with GBS. Some recent studies have shown that the intrapartum antibiotic prophylaxis of GBS-colonised women significantly reduces the incidence of GBS-caused sepsis in newborns. Routine examination for GBS is frequently recommended between the 35th and the 37th week of pregnancy. A CDC study has shown that this screening approach is 50% more effective than the use of antibiotics for pregnant women identified by clinical risk approach. Standard culture methods require 24 to 48 hours, and the results may not be available soon enough for efficient treatment. Thus, methods utilising more rapid screening techniques are required. The NADAL® Strep B Test is especially suitable if time and/or availability of culture methods are limited. It enables the detection of GBS directly from swabs, helping physicians make a presumptive diagnosis and decide whether a therapy should be indicated.
