Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context
Summary: Background: Timely management of sepsis with early targeted antimicrobial therapy improves patient outcomes. Rapid molecular assays (RMAs) have emerged, enabling the detection of bloodstream infection (BSI) with a shorter turnaround time than blood cultures (BCs). The accuracy of several R...
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Elsevier
2025-01-01
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537024006072 |
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| author | Gabriella Anna Rapszky Uyen Nguyen Do To Veronika Eszter Kiss Tamás Kói Anna Walter Dorottya Gergő Fanni Adél Meznerics Márton Rakovics Szilárd Váncsa Lajos Vince Kemény Dezső Csupor Péter Hegyi Michael R. Filbin Csaba Varga Bánk G. Fenyves |
| author_facet | Gabriella Anna Rapszky Uyen Nguyen Do To Veronika Eszter Kiss Tamás Kói Anna Walter Dorottya Gergő Fanni Adél Meznerics Márton Rakovics Szilárd Váncsa Lajos Vince Kemény Dezső Csupor Péter Hegyi Michael R. Filbin Csaba Varga Bánk G. Fenyves |
| author_sort | Gabriella Anna Rapszky |
| collection | DOAJ |
| description | Summary: Background: Timely management of sepsis with early targeted antimicrobial therapy improves patient outcomes. Rapid molecular assays (RMAs) have emerged, enabling the detection of bloodstream infection (BSI) with a shorter turnaround time than blood cultures (BCs). The accuracy of several RMAs has not been comprehensively reviewed. We aimed to identify commercial RMAs reported in the literature and evaluate their diagnostic performance compared to BC. Methods: A systematic review and meta-analysis was conducted, covering MEDLINE, Cochrane Library, Embase, and Web of Science from inception to September 23, 2024. Eligible studies included patients with suspected or documented BSI, tested with both an RMA (turnaround time of ≤12 h, targeting ≥20 pathogens) and BC. Non-original research articles and animal studies were excluded. The primary outcomes were pooled sensitivity and specificity of RMAs for pathogen detection compared to BC. Bivariate analysis was used to produce summary receiver operating characteristic plots and diagnostic metric measures stratified by different units of analysis (sample versus patient), RMA types, and patient populations. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and Quality Assessment of Diagnostic Accuracy Studies-Comparative (QUADAS-C) tools. The study was registered with PROSPERO, CRD42022377280. Findings: A total of 63,916 articles were identified, of which 104 were included in the qualitative synthesis and 75 in the quantitative synthesis, covering 17,952 samples and 11,393 patients analyzed separately. Eleven RMAs were identified, with four included in the RMA-based subgroup analysis (LightCycler SeptiFast Test MGRADE®, IRIDICA BAC BSI assay, SepsiTest, MagicPlex Sepsis Test) and five additional ones in the pooled analysis (UMD-SelectNA, VYOO®, MicrobScan assay, MicrobScan-Kairos24/7, REBA Sepsis-ID test). Two RMAs were included in the qualitative synthesis only (InfectID-BSI, Pilot Gene Technology droplet digital polymerase chain reaction). Pooled specificity of RMAs was higher (0.858, 95% confidence interval (CI) 0.830–0.883) than sensitivity (0.659, 95% CI 0.594–0.719) by patient. Sensitivities varied by RMA type from 0.492 (95% CI 0.390–0.594, MagicPlex Sepsis Test) to 0.783 (95% CI 0.662–0.870, IRIDICA BAC BSI assay) by patient. Specificities varied more by patient population, ranging from 0.811 (95% CI 0.716–0.879) in the intensive care population to 0.892 (95% CI 0.838–0.930) in the emergency department population, by patient. Similar metrics were observed when the analysis was done by sample. Risk of bias was judged to be high in all included articles. Interpretation: Despite their shorter turnaround time, low sensitivity means RMAs cannot replace BCs. However, our data indicate that RMAs may have value as an add-on test by increasing pathogen detection rates. Higher-sensitivity RMAs are needed which could possibly be achieved by expanding pathogen coverage and increasing blood sample volumes. High-quality implementation studies and standardized reporting are required to assess the clinical advantages of RMAs. Funding: Centre for Translational Medicine, Semmelweis University. |
| format | Article |
| id | doaj-art-ffc9eaa121534ab684f26fde61cfb57c |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj-art-ffc9eaa121534ab684f26fde61cfb57c2025-01-22T05:43:44ZengElsevierEClinicalMedicine2589-53702025-01-0179103028Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in contextGabriella Anna Rapszky0Uyen Nguyen Do To1Veronika Eszter Kiss2Tamás Kói3Anna Walter4Dorottya Gergő5Fanni Adél Meznerics6Márton Rakovics7Szilárd Váncsa8Lajos Vince Kemény9Dezső Csupor10Péter Hegyi11Michael R. Filbin12Csaba Varga13Bánk G. Fenyves14Department of Emergency Medicine, Semmelweis University, Budapest, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; András Pető Faculty, Semmelweis University, Budapest, HungaryDepartment of Emergency Medicine, Semmelweis University, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Budapest University of Technology and Economics, Department of Stochastics, Budapest, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Pharmacognosy, Semmelweis University, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Eötvös Loránd University, Faculty of Social Sciences, Department of Statistics, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary; Institute of Pancreatic Diseases, Semmelweis University, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Dermatology, Venereology and Dermatooncology, Semmelweis University, Budapest, Hungary; Department of Physiology, Semmelweis University, Budapest, Hungary; HCEMM-SU, Translational Dermatology Research Group, Semmelweis University, Budapest, HungaryInstitute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary; Institute of Clinical Pharmacy, University of Szeged, Szeged, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Institute for Translational Medicine, Medical School, University of Pécs, Pécs, Hungary; Institute of Pancreatic Diseases, Semmelweis University, Budapest, HungaryCentre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Emergency Medicine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USADepartment of Emergency Medicine, Semmelweis University, Budapest, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, HungaryDepartment of Emergency Medicine, Semmelweis University, Budapest, Hungary; Centre for Translational Medicine, Semmelweis University, Budapest, Hungary; Department of Molecular Biology, Semmelweis University, Budapest, Hungary; Corresponding author. Department of Emergency Medicine, Semmelweis University, Ulloi ut 26, Budapest 1085, Hungary.Summary: Background: Timely management of sepsis with early targeted antimicrobial therapy improves patient outcomes. Rapid molecular assays (RMAs) have emerged, enabling the detection of bloodstream infection (BSI) with a shorter turnaround time than blood cultures (BCs). The accuracy of several RMAs has not been comprehensively reviewed. We aimed to identify commercial RMAs reported in the literature and evaluate their diagnostic performance compared to BC. Methods: A systematic review and meta-analysis was conducted, covering MEDLINE, Cochrane Library, Embase, and Web of Science from inception to September 23, 2024. Eligible studies included patients with suspected or documented BSI, tested with both an RMA (turnaround time of ≤12 h, targeting ≥20 pathogens) and BC. Non-original research articles and animal studies were excluded. The primary outcomes were pooled sensitivity and specificity of RMAs for pathogen detection compared to BC. Bivariate analysis was used to produce summary receiver operating characteristic plots and diagnostic metric measures stratified by different units of analysis (sample versus patient), RMA types, and patient populations. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) and Quality Assessment of Diagnostic Accuracy Studies-Comparative (QUADAS-C) tools. The study was registered with PROSPERO, CRD42022377280. Findings: A total of 63,916 articles were identified, of which 104 were included in the qualitative synthesis and 75 in the quantitative synthesis, covering 17,952 samples and 11,393 patients analyzed separately. Eleven RMAs were identified, with four included in the RMA-based subgroup analysis (LightCycler SeptiFast Test MGRADE®, IRIDICA BAC BSI assay, SepsiTest, MagicPlex Sepsis Test) and five additional ones in the pooled analysis (UMD-SelectNA, VYOO®, MicrobScan assay, MicrobScan-Kairos24/7, REBA Sepsis-ID test). Two RMAs were included in the qualitative synthesis only (InfectID-BSI, Pilot Gene Technology droplet digital polymerase chain reaction). Pooled specificity of RMAs was higher (0.858, 95% confidence interval (CI) 0.830–0.883) than sensitivity (0.659, 95% CI 0.594–0.719) by patient. Sensitivities varied by RMA type from 0.492 (95% CI 0.390–0.594, MagicPlex Sepsis Test) to 0.783 (95% CI 0.662–0.870, IRIDICA BAC BSI assay) by patient. Specificities varied more by patient population, ranging from 0.811 (95% CI 0.716–0.879) in the intensive care population to 0.892 (95% CI 0.838–0.930) in the emergency department population, by patient. Similar metrics were observed when the analysis was done by sample. Risk of bias was judged to be high in all included articles. Interpretation: Despite their shorter turnaround time, low sensitivity means RMAs cannot replace BCs. However, our data indicate that RMAs may have value as an add-on test by increasing pathogen detection rates. Higher-sensitivity RMAs are needed which could possibly be achieved by expanding pathogen coverage and increasing blood sample volumes. High-quality implementation studies and standardized reporting are required to assess the clinical advantages of RMAs. Funding: Centre for Translational Medicine, Semmelweis University.http://www.sciencedirect.com/science/article/pii/S2589537024006072Rapid pathogen identificationWhole bloodSuspected sepsisDiagnostic methodBlood cultureDiagnostic accuracy |
| spellingShingle | Gabriella Anna Rapszky Uyen Nguyen Do To Veronika Eszter Kiss Tamás Kói Anna Walter Dorottya Gergő Fanni Adél Meznerics Márton Rakovics Szilárd Váncsa Lajos Vince Kemény Dezső Csupor Péter Hegyi Michael R. Filbin Csaba Varga Bánk G. Fenyves Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context EClinicalMedicine Rapid pathogen identification Whole blood Suspected sepsis Diagnostic method Blood culture Diagnostic accuracy |
| title | Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context |
| title_full | Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context |
| title_fullStr | Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context |
| title_full_unstemmed | Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context |
| title_short | Rapid molecular assays versus blood culture for bloodstream infections: a systematic review and meta-analysisResearch in context |
| title_sort | rapid molecular assays versus blood culture for bloodstream infections a systematic review and meta analysisresearch in context |
| topic | Rapid pathogen identification Whole blood Suspected sepsis Diagnostic method Blood culture Diagnostic accuracy |
| url | http://www.sciencedirect.com/science/article/pii/S2589537024006072 |
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