임신 여성에서 B군 사슬알균 검사[실시간 중합효소연쇄반응법]의 진단정확성과 검출률: 체계적 문헌고찰과 메타분석
Diagnostic Accuracy and Detection Rate of Real-Time PCR for Detection of Group B Streptococcal Colonization in Pregnant Women: Systemic Review of Literature and Meta-Analysis
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배경: B군 사슬알균(Group B streptococcus, GBS)은 신생아의 감염과 사망의 주요 원인균이다. 미국의 질병예방통제센터는 GBS의 수직감염을 예방하기 위하여 35-37주 임산부를 대상으로 배양, 라텍스 응집법(latex agglutination test) 또는 핵산 증폭 검사(nucleic acid amplification test)와 같은 검사법을 이용하여 GBS의 집락화 여부를 확인하고, 필요시 항균제를 사용하도록 권고하고 있다. 본 연구에서는 임신한 여성을 대상으로 GBS 검출을 위한 실시간 중합효소연쇄반응법(real-time polymerase chain reaction)의 진단정확성과 검출률을 조사하여 임상적 유효성을 확인하였다. 방법: 문헌검색은 KoreaMed, Ovid-MEDLINE, Ovid-EMBASE, Cochrane Library의 데이터베이스를 이용하여 2015년 11월 3일에 이루어졌다. 검색전략에 따라 ‘Group B Streptococcus’, ‘real time polymerase chain reaction’ 등의 단어로 검색하고, 수기검색된 2편을 포함하여 총 443편의 문헌이 확인되었다. 두 명의 연구자가 독립적으로 문헌을 선택하였으며, Scottish Intercollegiate Guidelines Network의 방법론적 체크리스트를 사용하여 문헌의 질을 확인하였다. 결과: 선택된 총 34편의 문헌에서 실시간 중합효소연쇄반응법의 진단정확성에 대한 메타분석이 수행되었다(실시간 중합효소연쇄반응법: 13,516건, 배양검사 및 기타검사: 1,815건). 문헌에서 실시간 중합효소연쇄반응으로 확인된 임산부의 GBS 집락화율을 2.0-69.8%였다. 중재검사의 진단정확성은 통합 민감도 0.93 (95% CI 0.92-0.94, I2=86.3%), 통합 특이도 0.96 (95% CI 0.96-0.96, I2=90.2%), SROC AUC (summary receiver operating characteristic area under the curve)가 0.99로 보고되었다. 결론: 임신부를 대상으로 GBS를 검출하는 실시간 중합효소연쇄반응법은 진단정확성이 높아 신생아 수직감염을 예방하는데 있어 유효성이 있는 검사로 판단된다. [Ann Clin Microbiol 2017;20:42-51]
Abstract
Background: Group B streptococcus (Streptococcus agalactiae, GBS) was reported as a major cause of neonatal infection and death. To prevent vertical transmission, CDC recommended that all women in week 35-37 of pregnancy should receive the GBS colonization test. We conducted a systematic review and meta-analysis to evaluate diagnostic accuracy and detection rate of real-time PCR for GBS in pregnant women. Methods: The literature review for GBS using real-time PCR was done including KoreaMed, Ovid- MEDLINE, Ovid-EMBASE, and Cochrane Library on November 3, 2015. 443 articles were collected. Two authors select articles and evaluated the quality of studies using Scottish Intercollegiate Guidelines Network tool independently. Results: Diagnostic accuracy of the real-time PCR was assessed by meta-analysis through 34 articles (13,516 for real-time PCR, 1,815 for culture and other comparison test). The GBS colonization was assessed through 34 articles, which reported varying values of 2.0-69.2% using real-time PCR. The real-time PCR for GBS was shown to have overall sensitivity of 0.93 (95% CI 0.92-0.94, I2=86.3%), overall specificity of 0.96 (95% CI 0.96-0.96, I2= 90.2%), SROC AUC of 0.99. Conclusion: Real-time PCR is an effective test for detecting GBS colonization in pregnant women, resulted in preventing the infection in a new born baby. (Ann Clin Microbiol 2017;20:-51)
참고문헌 (48)
- Atkins KL, "Evaluation of polymerase chain reaction for group B streptococcus detection using an improved culture method", Obstet Gynecol, 108, pp.488~491 (2006)
- Honest H, "Rapid tests for group B Streptococcus colonization in laboring women: a systematic review", Pediatrics, 117, pp.1055~1066 (2006)
- Bergeron MG, "Rapid detection of group B streptococci in pregnant women at delivery", N Engl J Med, 343, pp.175~179 (2000)
- 최창원, "신생아 B군 연쇄상구균 감염", Perinatology, 23(3), pp.131~142 (2012), 대한주산의학회
- 오지은, "한국 신생아에서 B군 사슬알균 감염증", Pediatric Infection and Vaccine, 19(2), pp.43~54 (2012), 대한소아감염학회
- 박정수, "Usefulness of a Rapid Real-time PCR Assay in Prenatal Screening for Group B Streptococcus Colonization", Annals of Laboratory Medicine, 33(1), pp.39~44 (2013), 대한진단검사의학회
- 이선화, "국내 여성 질-회음부에서 분리된 Group B Streptococcus (GBS) 보균율 및 항균제 감수성", Annals of Clinical Microbiology, 12(4), pp.180~185 (2009), 대한임상미생물학회
- Eun Ju Kim, "Risk Factors for Group B Streptococcus Colonization Among Pregnant Women in Korea", Epidemiology and Health, 33, pp.1~7 (2011), 한국역학회
- 최성진, "The Prevalence of Vaginal Microorganisms in Pregnant Women with Preterm Labor and Preterm Birth", Annals of Laboratory Medicine, 32(3), pp.194~200 (2012), 대한진단검사의학회
- Aziz N, "Comparison of rapid intrapartum screening methods for group B streptococcal vaginal colonization", J Matern Fetal Neonatal Med, 18, pp.225~229 (2005)
- Couturier BA, "Antepartum screening for group B Streptococcus by three FDA-cleared molecular tests and effect of shortened enrichment culture on molecular detection rates", J Clin Microbiol, 52, pp.3429~3432 (2014)
- Verani JR, "Prevention of perinatal group B streptococcal disease--revised guidelines from CDC, 2010", MMWR Recomm Rep, 59, pp.1~36 (2010)
- "Methodology checklist"[URL]
- "SIGN 50: a guideline developer’s handbook"[URL]
- Higgins JP, "Measuring inconsistency in meta-analyses", BMJ, 327, pp.557~560 (2003)
- Uh Y, "Studies on the usefulness of new Granada selective medium for the detection of group B streptococci in pregnant women", J Wonju Med Coll, 9, pp.7~15 (1996)
- Park LS, "A study of group B streptococcal infection in Korean pregnant women", Korean J Obstet Gynecol, 42, pp.2038~2042 (1999)
- 최길웅, "임신부에서 group B streptococci 감염의 임상적 의의", Obstetrics & Gynecology Science, 45(5), pp.811~815 (2002), 대한산부인과학회
- 김민우, "우리나라 임신부에서의 B군 사슬알균의집락화에 대한 연구", Obstetrics & Gynecology Science, 49(2), pp.337~344 (2006), 대한산부인과학회
- Buchan BW, "Multicenter clinical evaluation of the Xpert GBS LB assay for detection of group B Streptococcus in prenatal screening specimens", J Clin Microbiol, 53, pp.443~448 (2015)
- Miller SA, "Comparison of the AmpliVue, BD Max System, and illumigene Molecular Assays for Detection of Group B Streptococcus in antenatal screening specimens", J Clin Microbiol, 53, pp.1938~1941 (2015)
- Morozumi M, "Direct identification of Streptococcus agalactiae and capsular type by real-time PCR in vaginal swabs from pregnant women", J Infect Chemother, 21, pp.34~38 (2015)
- Yeung SW, "Evaluation of an in-house real-time polymerase chain reaction method to identify group B streptococcus colonization in pregnancy", J Obstet Gynaecol Res, 41, pp.1357~1362 (2015)
- Mueller M, "Intrapartum detection of Group B streptococci colonization by rapid PCR-test on labor ward", Eur J Obstet Gynecol Reprod Biol, 176, pp.137~141 (2014)
- Berg BR, "Culture-based method with performance comparable to that of PCR-based methods for detection of group B Streptococcus in screening samples from pregnant women", J Clin Microbiol, 51, pp.1253~1255 (2013)
- Poncelet-Jasserand E, "Reduction of the use of antimicrobial drugs following the rapid detection of Streptococcus agalactiae in the vagina at delivery by real-time PCR assay", BJOG, 120, pp.1098~1108 (2013)
- Feuerschuette OM, "Performance of RT-PCR in the detection of Streptococcus agalactiae in the anogenital tract of pregnant women", Arch Gynecol Obstet, 286, pp.1437~1442 (2012)
- Schwartz J, "Evaluation of the BD MAX GBS assay to detect Streptococcus group B in LIM broth-enriched antepartum vaginal-rectal specimens", Diagn Microbiol Infect Dis, 73, pp.97~98 (2012)
- Church DL, "Evaluation of the XpertⓇ group B streptococcus real-time polymerase chain reaction assay compared to StrepB Carrot BrothTM for the rapid intrapartum detection of group B streptococcus colonization", Diagn Microbiol Infect Dis, 69, pp.460~462 (2011)
- Young BC, "Evaluation of a rapid, real-time intrapartum group B streptococcus assay", Am J Obstet Gynecol, 205, pp.372.e1~372.e6 (2011)
- Alfa MJ, "Real-time PCR assay provides reliable assessment of intrapartum carriage of group B Streptococcus", J Clin Microbiol, 48, pp.3095~3099 (2010)
- Jordan JA, "Multicenter study evaluating performance of the Smart Group B Streptococcus (GBS) assay using an enrichment protocol for detecting GBS colonization in patients in the antepartum period", J Clin Microbiol, 48, pp.3193~3197 (2010)
- Riedlinger J, "Multicenter evaluation of the BD Max GBS assay for detection of group B streptococci in prenatal vaginal and rectal screening swab specimens from pregnant women", J Clin Microbiol, 48, pp.4239~4241 (2010)
- El Helali N, "Diagnostic accuracy of a rapid real-time polymerase chain reaction assay for universal intrapartum group B streptococcus screening", Clin Infect Dis, 49, pp.417~423 (2009)
- Scicchitano LM, "Comparative evaluation of the AccuProbe Group B Streptococcus Culture Test, the BD GeneOhm Strep B assay, and culture for detection of group B streptococci in pregnant women", J Clin Microbiol, 47, pp.3021~3023 (2009)
- Wei CF, "Prenatal group B Streptococcus test using real-time polymerase chain reaction", Taiwan J Obstet Gynecol, 48, pp.116~119 (2009)
- Wernecke M, "Evaluation of a novel real-time PCR test based on the ssrA gene for the identification of group B streptococci in vaginal swabs", BMC Infect Dis, 9, pp.148~ (2009)
- Block T, "Comparison of carrot broth- and selective Todd-Hewitt broth-enhanced PCR protocols for real-time detection of Streptococcus agalactiae in prenatal vaginal", anorectal specimens, 2008, pp.46, 3615~3620
- Edwards RK, "Rapid group B streptococci screening using a real-time polymerase chain reaction assay", Obstet Gynecol, 111, pp.1335~1341 (2008)
- Money D, "An evaluation of a rapid real time polymerase chain reaction assay for detection of group B streptococcus as part of a neonatal group B streptococcus prevention strategy", J Obstet Gynaecol Can, 30, pp.770~775 (2008)
- Smith D, "Comparison of BD GeneOhm real-time polymerase chain reaction with chromogenic and conventional culture methods for detection of group B Streptococcus in clinical samples", Diagn Microbiol Infect Dis, 61, pp.369~372 (2008)
- Bergseng H, "Real-time PCR targeting the sip gene for detection of group B streptococcus colonization in pregnant women at delivery", J Med Microbiol, 56, pp.223~228 (2007)
- Gavino M, "A comparison of a new rapid real-time polymerase chain reaction system to traditional culture in determining group B streptococcus colonization", Am J Obstet Gynecol, 197, pp.388.e1~381.e4 (2007)
- Goodrich JS, "Comparison of culture and 2real-time polymerase chain reaction assays to detect group B Streptococcus during antepartum screening", Diagn Microbiol Infect Dis, 59, pp.17~22 (2007)
- Chan KL, "Evaluation of the sensitivity of a rapid polymerase chain reaction for detection of group B streptococcus", J Obstet Gynaecol, 26, pp.402~406 (2006)
- Réglier-Poupet H, "Prospective evaluation of a real-time PCR assay for detection of group B streptococci in vaginal swabs from pregnant women", Eur J Clin Microbiol Infect Dis, 24, pp.355~357 (2005)
- Uhl JR, "Use of the Roche LightCycler Strep B assay for detection of group B streptococcus from vaginal and rectal swabs", J Clin Microbiol, 43, pp.4046~4051 (2005)
- Davies HD, "Multicenter study of a rapid molecular-based assay for the diagnosis of group B Streptococcus colonization in pregnant women", Clin Infect Dis, 39, pp.1129~1135 (2004)
