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Syndromic and Point-of-Care Molecular Testing

      Syndromic and point-of-care molecular diagnostic testing methods have revolutionized infectious disease testing by permitting the simultaneous detection of multiple pathogens and drug resistance mechanisms directly from clinical specimens and positive blood cultures.

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      References

        • Daly J.A.
        • Clifton N.L.
        • Seskin K.C.
        • et al.
        Use of rapid, nonradioactive DNA probes in culture confirmation tests to detect Streptococcus agalactiae, Haemophilus influenza, and Enterococcus spp. from pediatric patients with significant infections.
        J Clin Microbiol. 1991; 29: 80-82
        • Davis T.E.
        • Fuller D.D.
        Direct identification of bacterial isolates in blood cultures by using a DNA probe.
        J Clin Microbiol. 1991; 29: 2193-2196
        • Lumb R.
        • Lanser J.A.
        • Lim I.S.
        Rapid identification of mycobacteria by the Gen-Probe Accuprobe system.
        Pathology. 1993; 25: 313-315
        • Padhye A.A.
        • Smith G.
        • Standard P.G.
        • et al.
        Comparative evaluation of chemilluminescent DNA probe assays and exoantigen tests for rapid identification of Blastomyces dermatitidis and Coccidioides immitis.
        J Clin Microbiol. 1994; 32: 867-870
        • Sninsky J.J.
        The polymerase chain reaction (PCR): a valuable method for retroviral detection.
        Lymphology. 1990; 23: 92-97
        • Persing D.H.
        • Mathiesen D.
        • Marshall W.F.
        • et al.
        Detection of Babesia microti by polymerase chain reaction.
        J Clin Microbiol. 1992; 30: 2097-2103
        • Karron R.A.
        • Froehlich J.L.
        • Bobo L.
        • et al.
        Rapid detection of parainfluenza virus type 3 RNA in respiratory specimens: use of reverse-transcription-PCR-enzyme immunoassay.
        J Clin Microbiol. 1994; 32: 484-488
        • Orlando C.
        • Pinzani P.
        • Pazzagli M.
        Developments in quantitative PCR.
        Clin Chem Lab Med. 1998; 36: 255-269
        • Abbott A.N.
        • Fang F.C.
        Clinical impact of multiplex syndromic panels in the diagnosis of bloodstream, gastrointestinal, respiratory, and central nervous system infections.
        Clin Microbiol Newsl. 2017; 39: 133-142
        • Messacar K.
        • Hurst A.L.
        • Child J.
        • et al.
        Clinical impact and provider acceptability of real-time antimicrobial stewardship decision support for rapid diagnostics in children with positive blood culture results.
        J Pediatric Infect Dis Soc. 2016; 6: 267-274
        • Rappo U.
        • Schuetz A.N.
        • Jenkins S.G.
        • et al.
        Impact of early detection of respiratory viruses by multiplex PCR assay on clinical outcomes in adult patients.
        J Clin Microbiol. 2016; 54: 2096-2103
        • Ward C.
        • Stocker K.
        • Begum J.
        • et al.
        Performance evaluation of the Verigene® (Nanosphere) and FilmArray® (BioFire®) molecular assays for identification of causative organisms in bacterial bloodstream infections.
        Eur J Clin Microbiol Infect Dis. 2015; 34: 487-496
        • Salimnia H.
        • Fairfax M.R.
        • Lephart P.R.
        • et al.
        Evaluation of the FilmArray blood culture identification panel: results of a multicenter controlled trial.
        J Clin Microbiol. 2016; 54: 687-698
        • Van Der Pol B.
        Profile of the triplex assay for detection of chlamydia, gonorrhea, and trichomonas using the BD MAX system.
        Expert Rev Mol Diagn. 2017; 17: 539-547
        • Madison-Antenucci S.
        • Relich R.F.
        • Doyle L.
        • et al.
        Multicenter evaluation of the BD MAX enteric parasite real-time PCR assay for detection of Giardia duodenalis, Cryptosporidium hominis, Cryptosporidium parvum, and Entamoeba histolytica.
        J Clin Microbiol. 2016; 54: 2681-2688
        • Knabl L.
        • Grutsch I.
        • Orth-Höller D.
        Comparison of the BD MAX enteric pathogen panel with conventional diagnostic procedures in diarrheal stool samples.
        Eur J Clin Microbiol Infect Dis. 2016; 35: 131-136
        • Simner P.J.
        • Oethinger M.
        • Stellrecht K.A.
        • et al.
        Multisite evaluation of the BD MAX extended enteric bacterial panel for detection of Yersinia enterocolitica, enterotoxigenic Escherichia coli, Vibrio, and Plesiomonas shigelloides from stool specimens.
        J Clin Microbiol. 2017; 55: 3258-3266
        • Nijhuis R.H.T.
        • Guerendiain D.
        • Claas E.C.J.
        Comparison of the ePlex respiratory pathogen panel with laboratory-developed real-time PCR assays for detection of respiratory pathogens.
        J Clin Microbiol. 2017; 55: 1938-1945
        • Pierce V.M.
        • Hodinka R.L.
        Comparison of the GenMark diagnostics eSensor respiratory viral panel to real-time PCR for detection of respiratory viruses in children.
        J Clin Microbiol. 2012; 50: 3458-3465
        • Babady N.E.
        • England M.R.
        • Jurcic Smith K.L.
        • et al.
        Multicenter evaluation of the ePlex respiratory pathogen panel for the detection of viral and bacterial respiratory tract pathogens in nasopharyngeal swabs.
        J Clin Microbiol. 2018; 56 ([pii:e01658-17])
        • Van Rijn A.L.
        • Nijhuis R.H.T.
        • Bekker V.
        • et al.
        Clinical implications of rapid ePlex respiratory pathogen panel testing compared to laboratory-developed real-time PCR.
        Eur J Clin Microbiol Infect Dis. 2018; 37: 571-577
        • McCoy M.H.
        • Relich R.F.
        • Davis T.E.
        • et al.
        Performance of the FilmArray blood culture identification panel utilized by non-expert staff compared to conventional microbial identification and antimicrobial resistance gene detection from positive blood cultures.
        J Med Microbiol. 2016; 65: 619-625
        • Rogers B.B.
        • Shankar P.
        • Jerris R.C.
        • et al.
        Impact of a rapid respiratory panel test on patient outcomes.
        Arch Pathol Lab Med. 2015; 139: 636-641
        • Kanack K.J.
        Rapid respiratory panel testing influences patient management and clinical outcomes.
        MLO Med Lab Obs. 2014; 46: 16
        • MacVane S.H.
        • Nolte F.S.
        Benefits of adding a rapid PCR-based blood culture identification panel to an established antimicrobial stewardship program.
        J Clin Microbiol. 2016; 54: 2455-2463
        • Southern T.R.
        • Van Schooneveld T.C.
        • Bannister D.L.
        • et al.
        Implementation and performance of the BioFire FilmArray blood culture identification panel with antimicrobial treatment recommendations for bloodstream infections at a midwestern academic tertiary hospital.
        Diagn Microbiol Infect Dis. 2015; 81: 96-101
        • Buss S.N.
        • Leber A.
        • Chapin K.
        • et al.
        Multicenter evaluation of the BioFire FilmArray gastrointestinal panel for etiologic diagnosis of infectious gastroenteritis.
        J Clin Microbiol. 2015; 53: 915-925
        • Prakash V.P.
        • LeBlanc L.
        • Alexander-Scott N.E.
        • et al.
        Use of a culture-independent gastrointestinal multiplex PCR panel during a shigellosis outbreak: considerations for clinical laboratories and public health.
        J Clin Microbiol. 2015; 53: 1048-1049
        • Hanson K.E.
        • Slechta E.S.
        • Killpack J.A.
        • et al.
        Preclinical assessment of a fully automated multiplex PCR panel for detection of central nervous system pathogens.
        J Clin Microbiol. 2016; 54: 785-787
        • Duff S.
        • Hasbun R.
        • Ginocchio C.C.
        • et al.
        Economic analysis of rapid multiplex polymerase chain reaction testing for meningitis/encephalitis in pediatric patients.
        Future Microbiol. 2018; 13: 617-629
        • Gay-Andrieu F.
        • Magassouba N.
        • Picto V.
        • et al.
        Clinical evaluation of the BioFire FilmArray BioThreat-E test for the diagnosis of Ebola virus disease in Guinea.
        J Clin Virol. 2017; 92: 20-24
        • Papan C.
        • Meyer-Buehn M.
        • Laniado G.
        • et al.
        Assessment of the multiplex PCR-based assay Unyvero pneumonia application for detection of bacterial pathogens and antibiotic resistance genes in children and neonates.
        Infection. 2018; 46: 189-196
        • Personne Y.
        • Ozongwu C.
        • Platt G.
        • et al.
        ‘Sample-in, answer-out’? Evaluation and comprehensive analysis of the Unyvero P50 pneumonia assay.
        Diagn Microbiol Infect Dis. 2016; 86: 5-10
        • Ledeboer N.A.
        • Lopansri B.K.
        • Dhiman N.
        • et al.
        Identification of Gram-negative bacteria and genetic resistance determinants from positive blood culture broths by use of the Verigene Gram-negative blood culture multiplex microarray-based molecular assay.
        J Clin Microbiol. 2015; 53: 2460-2472
        • Buchan B.W.
        • Ginocchio C.C.
        • Manii R.
        • et al.
        Multiplex identification of Gram-positive bacteria and resistance determinants directly from positive blood culture broths: evaluation of an automated microarray-based nucleic acid test.
        PLoS Med. 2013; 10: e1001478
        • Esposito S.
        • Principi N.
        The role of the NxTAG respiratory pathogen panel assay and other multiplex platforms in clinical practice.
        Expert Rev Mol Diagn. 2017; 17: 9-17
        • Tang Y.W.
        • Gonsalves S.
        • Sun J.Y.
        • et al.
        Clinical evaluation of the Luminex NxTAG respiratory pathogen panel.
        J Clin Microbiol. 2016; 54: 1912-1914
        • Huang R.S.
        • Johnson C.L.
        • Pritchard L.
        • et al.
        Performance of the Verigene enteric pathogens test, BioFire FilmArray gastrointestinal panel and Luminex xTAG gastrointestinal pathogen panel for detection of common enteric pathogens.
        Diagn Microbiol Infect Dis. 2016; 86: 336-339
        • Ramanan P.
        • Bryson A.L.
        • Binnicker M.J.
        • et al.
        Syndromic panel-based testing in clinical microbiology.
        Clin Microbiol Rev. 2017; 31 ([pii:e00024-17])
        • Leber A.L.
        • Everhart K.
        • Balada-Llasat J.M.
        • et al.
        Multicenter evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for detection of bacteria, viruses, and yeast in cerebrospinal fluid specimens.
        J Clin Microbiol. 2016; 54: 2251-2261
        • Dien Bard J.
        • Alby K.
        Point-counterpoint: meningitis/encephalitis syndromic testing in the clinical laboratory.
        J Clin Microbiol. 2018; 56 ([pii:e00018-18])
        • Cybulski Jr., R.J.
        • Bateman A.C.
        • Bourassa L.
        • et al.
        Clinical impact of a multiplex gastrointestinal PCR panel in patients with acute gastroenteritis.
        Clin Infect Dis. 2018; https://doi.org/10.1093/cid/ciy357
        • Leber A.L.
        • Everhart K.
        • Daly J.A.
        • et al.
        Multicenter evaluation of BioFire FilmArray Respiratory Panel 2 for detection of viruses and bacteria in nasopharyngeal swab samples.
        J Clin Microbiol. 2018; 25 ([pii:e01945-17]): 56
      1. Kawa D, Paradis S, Yu JH, et al. Evaluating the standard of care for women’s health: the BD MAX Vaginal Panel and management of vaginal infections (white paper). 2017. Available at: http://moleculardiagnostics.bd.com/wp-content/uploads/2017/08/MAX-Vaginal-Panel-Whitepaper.pdf. Accessed June 25, 2018.

        • Young S.
        • Illescas P.
        • Nicasio J.
        • et al.
        Diagnostic accuracy of the real-time PCR cobas Liat influenza A/B assay and the Alere i influenza A&B NEAR isothermal nucleic acid amplification assay for the detection of influenza using adult nasopharyngeal specimens.
        J Clin Virol. 2017; 94: 86-90
        • Davis S.
        • Allen A.J.
        • O’Leary R.
        • et al.
        Diagnostic accuracy and cost analysis of the Alere i influenza A&B near-patient test using throat swabs.
        J Hosp Infect. 2017; 97: 301-309
        • Hassan F.
        • Hays L.M.
        • Bonner A.
        • et al.
        Multicenter clinical evaluation of the Alere i respiratory syncytial virus isothermal nucleic acid amplification assay.
        J Clin Microbiol. 2018; 56 ([pii:e01777-17])
        • Schnee S.V.
        • Pfeil J.
        • Ihling C.M.
        • et al.
        Performance of the Alere i RSV assay for point-of-care detection of respiratory syncytial virus in children.
        BMC Infect Dis. 2017; 17: 767
        • Cohen D.M.
        • Russo M.E.
        • Jaggi P.
        • et al.
        Multicenter clinical evaluation of the novel Alere i Strep A isothermal nucleic acid amplification test.
        J Clin Microbiol. 2015; 53: 2258-2261
        • Berry G.J.
        • Miller C.R.
        • Prats M.M.
        • et al.
        Comparison of the Alere i Strep A test and the BD Veritor system in the detection of group A Streptococcus and the hypothetical impact of results on antibiotic utilization.
        J Clin Microbiol. 2018; 56 ([pii:e01310-17])
        • Melchers W.J.G.
        • Kuijpers J.
        • Sickler J.J.
        • et al.
        Lab-in-a-tube: real-time molecular point-of-care diagnostics for influenza A and B using the cobas Liat system.
        J Med Virol. 2017; 89: 1382-1386
        • Gibson J.
        • Schechter-Perkins E.M.
        • Mitchell P.
        • et al.
        Multi-center evaluation of the cobas Liat Influenza A/B & RSV assay for rapid point of care diagnosis.
        J Clin Virol. 2017; 95: 5-9
        • Ling L.
        • Kaplan S.E.
        • Lopez J.C.
        • et al.
        Parallel validation of three molecular devices for simultaneous detection and identification of influenza A and B and respiratory syncytial viruses.
        J Clin Microbiol. 2018; 56 ([pii:e01691-17])
        • Gaydos C.A.
        • Schwebke J.
        • Dombrowski J.
        • et al.
        Clinical performance of the Solana point-of-care trichomonas assay from clinician-collected vaginal swabs and urine specimens from symptomatic and asymptomatic women.
        Expert Rev Mol Diagn. 2017; 17: 303-306