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Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women
Background. Current prevention of infection due to group B Streptococcus (GBS) involves giving intrapartum antibiotics to women on the basis of either antenatal culture colonization status or presence of risk factors. Methods. We prospectively compared the performance characteristics of a rapid mole...
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Published in: | Clinical infectious diseases 2004-10, Vol.39 (8), p.1129-1135 |
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description | Background. Current prevention of infection due to group B Streptococcus (GBS) involves giving intrapartum antibiotics to women on the basis of either antenatal culture colonization status or presence of risk factors. Methods. We prospectively compared the performance characteristics of a rapid molecular diagnostic test (IDI-Strep B; Infectio Diagnostic) with culture for intrapartum GBS detection after 36 weeks' gestation in 5 North American centers during the period September 2001–May 2002. Antenatal GBS screening was done according to the usual practice of participating hospitals. Two combined vaginal/anal specimens were obtained from participants during labor by use of standard techniques and processed by the same laboratories that processed the antenatal specimens. Each swab sample was processed simultaneously by culture and with IDI-Strep B. The collected specimens were randomized for order of testing of the swab samples by culture or the rapid test. Results. Of enrolled women, 803 (91.1%) were eligible for analysis. The overall intrapartum GBS colonization rate by culture was 18.6% (range, 9.1%–28.7%). Compared with intrapartum culture, the molecular test had a sensitivity of 94.0% (range, 90.1%–97.8%), specificity of 95.9% (range, 94.3%–97.4%), positive predictive value of 83.8% (range, 78.2%–89.4%), and negative predictive value of 98.6% (range, 97.7%–99.5%). The molecular test was superior to antenatal cultures (sensitivity, 94% vs. 54%; P < .0001) and prediction of intrapartum status on the basis of risk factors (sensitivity, 94% vs. 42%; P < .0001). Conclusion. Use of this test for determination of GBS colonization during labor is highly sensitive and specific and may lead to a further reduction in rates of neonatal GBS disease. |
doi_str_mv | 10.1086/424518 |
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Dele ; Miller, Mark A. ; Faro, Sebastian ; Gregson, Dan ; Kehl, Sue C. ; Jordan, Jeanne A.</creator><creatorcontrib>Davies, H. Dele ; Miller, Mark A. ; Faro, Sebastian ; Gregson, Dan ; Kehl, Sue C. ; Jordan, Jeanne A.</creatorcontrib><description>Background. Current prevention of infection due to group B Streptococcus (GBS) involves giving intrapartum antibiotics to women on the basis of either antenatal culture colonization status or presence of risk factors. Methods. We prospectively compared the performance characteristics of a rapid molecular diagnostic test (IDI-Strep B; Infectio Diagnostic) with culture for intrapartum GBS detection after 36 weeks' gestation in 5 North American centers during the period September 2001–May 2002. Antenatal GBS screening was done according to the usual practice of participating hospitals. Two combined vaginal/anal specimens were obtained from participants during labor by use of standard techniques and processed by the same laboratories that processed the antenatal specimens. Each swab sample was processed simultaneously by culture and with IDI-Strep B. The collected specimens were randomized for order of testing of the swab samples by culture or the rapid test. Results. Of enrolled women, 803 (91.1%) were eligible for analysis. The overall intrapartum GBS colonization rate by culture was 18.6% (range, 9.1%–28.7%). Compared with intrapartum culture, the molecular test had a sensitivity of 94.0% (range, 90.1%–97.8%), specificity of 95.9% (range, 94.3%–97.4%), positive predictive value of 83.8% (range, 78.2%–89.4%), and negative predictive value of 98.6% (range, 97.7%–99.5%). The molecular test was superior to antenatal cultures (sensitivity, 94% vs. 54%; P < .0001) and prediction of intrapartum status on the basis of risk factors (sensitivity, 94% vs. 42%; P < .0001). Conclusion. Use of this test for determination of GBS colonization during labor is highly sensitive and specific and may lead to a further reduction in rates of neonatal GBS disease.</description><identifier>ISSN: 1058-4838</identifier><identifier>EISSN: 1537-6591</identifier><identifier>DOI: 10.1086/424518</identifier><identifier>PMID: 15486835</identifier><language>eng</language><publisher>United States: The University of Chicago Press</publisher><subject>Bacterial Typing Techniques - methods ; Blood ; Carrier State - diagnosis ; Carrier State - microbiology ; Childbirth ; Cultural values ; Culture Techniques ; False Positive Reactions ; Female ; Humans ; Infectious diseases ; Major Articles ; Neonatal diseases ; Polymerase chain reaction ; Predictive Value of Tests ; Predisposing factors ; Pregnancy ; Pregnancy Complications, Infectious - diagnosis ; Pregnancy Complications, Infectious - microbiology ; Preventive medicine ; Prospective Studies ; Risk Factors ; Sensitivity and Specificity ; Specimens ; Streptococcus ; Streptococcus agalactiae ; Streptococcus agalactiae - classification ; Streptococcus agalactiae - isolation & purification ; Time Factors</subject><ispartof>Clinical infectious diseases, 2004-10, Vol.39 (8), p.1129-1135</ispartof><rights>Copyright 2004 The Infectious Diseases Society of America</rights><rights>2004 by the Infectious Diseases Society of America 2004</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c423t-d0b53fdba4aea090053dc0e41aeb48a271bc8aa92cde94eeef76db4b1128bc793</citedby><cites>FETCH-LOGICAL-c423t-d0b53fdba4aea090053dc0e41aeb48a271bc8aa92cde94eeef76db4b1128bc793</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/4462875$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/4462875$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,58238,58471</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15486835$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Davies, H. Dele</creatorcontrib><creatorcontrib>Miller, Mark A.</creatorcontrib><creatorcontrib>Faro, Sebastian</creatorcontrib><creatorcontrib>Gregson, Dan</creatorcontrib><creatorcontrib>Kehl, Sue C.</creatorcontrib><creatorcontrib>Jordan, Jeanne A.</creatorcontrib><title>Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women</title><title>Clinical infectious diseases</title><addtitle>Clinical Infectious Diseases</addtitle><addtitle>Clinical Infectious Diseases</addtitle><description>Background. Current prevention of infection due to group B Streptococcus (GBS) involves giving intrapartum antibiotics to women on the basis of either antenatal culture colonization status or presence of risk factors. Methods. We prospectively compared the performance characteristics of a rapid molecular diagnostic test (IDI-Strep B; Infectio Diagnostic) with culture for intrapartum GBS detection after 36 weeks' gestation in 5 North American centers during the period September 2001–May 2002. Antenatal GBS screening was done according to the usual practice of participating hospitals. Two combined vaginal/anal specimens were obtained from participants during labor by use of standard techniques and processed by the same laboratories that processed the antenatal specimens. Each swab sample was processed simultaneously by culture and with IDI-Strep B. The collected specimens were randomized for order of testing of the swab samples by culture or the rapid test. Results. Of enrolled women, 803 (91.1%) were eligible for analysis. The overall intrapartum GBS colonization rate by culture was 18.6% (range, 9.1%–28.7%). Compared with intrapartum culture, the molecular test had a sensitivity of 94.0% (range, 90.1%–97.8%), specificity of 95.9% (range, 94.3%–97.4%), positive predictive value of 83.8% (range, 78.2%–89.4%), and negative predictive value of 98.6% (range, 97.7%–99.5%). The molecular test was superior to antenatal cultures (sensitivity, 94% vs. 54%; P < .0001) and prediction of intrapartum status on the basis of risk factors (sensitivity, 94% vs. 42%; P < .0001). Conclusion. Use of this test for determination of GBS colonization during labor is highly sensitive and specific and may lead to a further reduction in rates of neonatal GBS disease.</description><subject>Bacterial Typing Techniques - methods</subject><subject>Blood</subject><subject>Carrier State - diagnosis</subject><subject>Carrier State - microbiology</subject><subject>Childbirth</subject><subject>Cultural values</subject><subject>Culture Techniques</subject><subject>False Positive Reactions</subject><subject>Female</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Major Articles</subject><subject>Neonatal diseases</subject><subject>Polymerase chain reaction</subject><subject>Predictive Value of Tests</subject><subject>Predisposing factors</subject><subject>Pregnancy</subject><subject>Pregnancy Complications, Infectious - diagnosis</subject><subject>Pregnancy Complications, Infectious - microbiology</subject><subject>Preventive medicine</subject><subject>Prospective Studies</subject><subject>Risk Factors</subject><subject>Sensitivity and Specificity</subject><subject>Specimens</subject><subject>Streptococcus</subject><subject>Streptococcus agalactiae</subject><subject>Streptococcus agalactiae - classification</subject><subject>Streptococcus agalactiae - isolation & purification</subject><subject>Time Factors</subject><issn>1058-4838</issn><issn>1537-6591</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><recordid>eNqFkU1v1DAQhiMEoqXAL0DIvfQWsOPPHNultEi7BVEQiIs1cSbFJRsvtiOxiB9PVlm1J8RpRppnHo3mLYrnjL5i1KjXohKSmQfFIZNcl0rW7OHUU2lKYbg5KJ6kdEspY4bKx8UBk8Iow-Vh8Wc19tk7HDJGcp3HdktCR4B8hI1vySr06MYeYnkGCVtymhJsSRciyd-RvPFwM4Tk027lIoZxQ84mR8RNDi44NyayCH0Y_G_IPgzED-RDxJsBhky-hDUOT4tHHfQJn-3rUfH57fmnxWW5fH_xbnG6LJ2oeC5b2kjetQ0IQKA1pZK3jqJggI0wUGnWOANQV67FWiBip1XbiIaxyjRO1_yoOJm9mxh-jpiyXfvksO9hwDAmq1Stharkf0GmdS0UN_egiyGliJ3dRL-GuLWM2l0gdg5kAl_ujWOzxvYe2ycwAcczML3v35IXM3Obcoh3lJhuNnqnKOexTxl_3Y0h_rBKcy3t5ddvdkW5uqquru2S_wULN6l6</recordid><startdate>20041015</startdate><enddate>20041015</enddate><creator>Davies, H. Dele</creator><creator>Miller, Mark A.</creator><creator>Faro, Sebastian</creator><creator>Gregson, Dan</creator><creator>Kehl, Sue C.</creator><creator>Jordan, Jeanne A.</creator><general>The University of Chicago Press</general><general>University of Chicago Press</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>C1K</scope><scope>7X8</scope></search><sort><creationdate>20041015</creationdate><title>Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women</title><author>Davies, H. Dele ; Miller, Mark A. ; Faro, Sebastian ; Gregson, Dan ; Kehl, Sue C. ; Jordan, Jeanne A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c423t-d0b53fdba4aea090053dc0e41aeb48a271bc8aa92cde94eeef76db4b1128bc793</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Bacterial Typing Techniques - methods</topic><topic>Blood</topic><topic>Carrier State - diagnosis</topic><topic>Carrier State - microbiology</topic><topic>Childbirth</topic><topic>Cultural values</topic><topic>Culture Techniques</topic><topic>False Positive Reactions</topic><topic>Female</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Major Articles</topic><topic>Neonatal diseases</topic><topic>Polymerase chain reaction</topic><topic>Predictive Value of Tests</topic><topic>Predisposing factors</topic><topic>Pregnancy</topic><topic>Pregnancy Complications, Infectious - diagnosis</topic><topic>Pregnancy Complications, Infectious - microbiology</topic><topic>Preventive medicine</topic><topic>Prospective Studies</topic><topic>Risk Factors</topic><topic>Sensitivity and Specificity</topic><topic>Specimens</topic><topic>Streptococcus</topic><topic>Streptococcus agalactiae</topic><topic>Streptococcus agalactiae - classification</topic><topic>Streptococcus agalactiae - isolation & purification</topic><topic>Time Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Davies, H. Dele</creatorcontrib><creatorcontrib>Miller, Mark A.</creatorcontrib><creatorcontrib>Faro, Sebastian</creatorcontrib><creatorcontrib>Gregson, Dan</creatorcontrib><creatorcontrib>Kehl, Sue C.</creatorcontrib><creatorcontrib>Jordan, Jeanne A.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Environmental Sciences and Pollution Management</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Davies, H. Dele</au><au>Miller, Mark A.</au><au>Faro, Sebastian</au><au>Gregson, Dan</au><au>Kehl, Sue C.</au><au>Jordan, Jeanne A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women</atitle><jtitle>Clinical infectious diseases</jtitle><stitle>Clinical Infectious Diseases</stitle><addtitle>Clinical Infectious Diseases</addtitle><date>2004-10-15</date><risdate>2004</risdate><volume>39</volume><issue>8</issue><spage>1129</spage><epage>1135</epage><pages>1129-1135</pages><issn>1058-4838</issn><eissn>1537-6591</eissn><abstract>Background. Current prevention of infection due to group B Streptococcus (GBS) involves giving intrapartum antibiotics to women on the basis of either antenatal culture colonization status or presence of risk factors. Methods. We prospectively compared the performance characteristics of a rapid molecular diagnostic test (IDI-Strep B; Infectio Diagnostic) with culture for intrapartum GBS detection after 36 weeks' gestation in 5 North American centers during the period September 2001–May 2002. Antenatal GBS screening was done according to the usual practice of participating hospitals. Two combined vaginal/anal specimens were obtained from participants during labor by use of standard techniques and processed by the same laboratories that processed the antenatal specimens. Each swab sample was processed simultaneously by culture and with IDI-Strep B. The collected specimens were randomized for order of testing of the swab samples by culture or the rapid test. Results. Of enrolled women, 803 (91.1%) were eligible for analysis. The overall intrapartum GBS colonization rate by culture was 18.6% (range, 9.1%–28.7%). Compared with intrapartum culture, the molecular test had a sensitivity of 94.0% (range, 90.1%–97.8%), specificity of 95.9% (range, 94.3%–97.4%), positive predictive value of 83.8% (range, 78.2%–89.4%), and negative predictive value of 98.6% (range, 97.7%–99.5%). The molecular test was superior to antenatal cultures (sensitivity, 94% vs. 54%; P < .0001) and prediction of intrapartum status on the basis of risk factors (sensitivity, 94% vs. 42%; P < .0001). Conclusion. Use of this test for determination of GBS colonization during labor is highly sensitive and specific and may lead to a further reduction in rates of neonatal GBS disease.</abstract><cop>United States</cop><pub>The University of Chicago Press</pub><pmid>15486835</pmid><doi>10.1086/424518</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Bacterial Typing Techniques - methods Blood Carrier State - diagnosis Carrier State - microbiology Childbirth Cultural values Culture Techniques False Positive Reactions Female Humans Infectious diseases Major Articles Neonatal diseases Polymerase chain reaction Predictive Value of Tests Predisposing factors Pregnancy Pregnancy Complications, Infectious - diagnosis Pregnancy Complications, Infectious - microbiology Preventive medicine Prospective Studies Risk Factors Sensitivity and Specificity Specimens Streptococcus Streptococcus agalactiae Streptococcus agalactiae - classification Streptococcus agalactiae - isolation & purification Time Factors |
title | Multicenter Study of a Rapid Molecular-Based Assay for the Diagnosis of Group B Streptococcus Colonization in Pregnant Women |
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