Clinical accuracy of point-of-care urine culture in general practice

Anne Holm, Gloria Cordoba, Tina Møller Sørensen, Lisbeth Rem Jessen, Niels Frimodt-Møller, Volkert Siersma, Lars Bjerrum, Anne Holm, Gloria Cordoba, Tina Møller Sørensen, Lisbeth Rem Jessen, Niels Frimodt-Møller, Volkert Siersma, Lars Bjerrum

Abstract

Objective: To assess the clinical accuracy (sensitivity (SEN), specificity (SPE), positive predictive value and negative predictive value) of two point-of-care (POC) urine culture tests for the identification of urinary tract infection (UTI) in general practice.

Design: Prospective diagnostic accuracy study comparing two index tests (Flexicult™ SSI-Urinary Kit or ID Flexicult™) with a reference standard (urine culture performed in the microbiological department).

Setting: General practice in the Copenhagen area patients. Adult female patients consulting their general practitioner with suspected uncomplicated, symptomatic UTI.

Main outcome measures: (1) Overall accuracy of POC urine culture in general practice. (2) Individual accuracy of each of the two POC tests in this study. (3) Accuracy of POC urine culture in general practice with enterococci excluded, since enterococci are known to multiply in boric acid used for transportation for the reference standard. (4) Accuracy based on expert reading of photographs of POC urine cultures performed in general practice. Standard culture performed in the microbiological department was used as reference standard for all four measures.

Results: Twenty general practices recruited 341 patients with suspected uncomplicated UTI. The overall agreement between index test and reference was 0.76 (CI: 0.71-0.80), SEN 0.88 (CI: 0.83-0.92) and SPE 0.55 (CI: 0.46-0.64). The two POC tests produced similar results individually. Overall agreement with enterococci excluded was 0.82 (0.77-0.86) and agreement between expert readings of photographs and reference results was 0.81 (CI: 0.76-0.85).

Conclusions: POC culture used in general practice has high SEN but low SPE. Low SPE could be due to both misinterpretation in general practice and an imperfect reference standard. Registration number: ClinicalTrials.gov NCT02323087.

Keywords: Urinary tract infections; culture media; general practice; microbiological diagnosis; point-of-care testing.

Figures

Figure 1.
Figure 1.
Attrition flowchart.
Figure 2.
Figure 2.
Examples of cultures diagnosed incorrectly in general practice according to the reference standard. A and D: Correctly answered as negative in general practice according to the photograph and as S. saprofyticus 104 CFU/mL and Citrobacter koseri 104 CFU/mL in the microbiological department. B and E: Correctly answered as E. coli 103 CFU/mL and Enterococcus faecalis 105 CFU/mL in general practice but as negative in the microbiological department. C and F: Incorrectly answered as significant growth in general practice, and as negative and mixed flora in the microbiological department.

References

    1. Petersen I, Hayward AC.. Antibacterial prescribing in primary care. J Antimicrob Chemother. 2007;60:i43–i47.
    1. Colgan R, Keating K, Dougouih M.. Survey of symptom burden in women with uncomplicated urinary tract infections. Clin Drug Investig. 2004;24:55–60.
    1. Bermingham SL, Ashe JF.. Systematic review of the impact of urinary tract infections on health-related quality of life. BJU Int. 2012;110:E830–E836.
    1. Leydon GM, Turner S, Smith H, et al. . The journey from self-care to GP care: a qualitative interview study of women presenting with symptoms of urinary tract infection. Br J Gen Pract. 2009;59:e219–225.
    1. Hummers-Pradier E, Kochen M.. Urinary tract infections in adult general practice patients. Br J Gen Pract. 2002;52:752–761.
    1. Goossens H, Sprenger MJ.. Community acquired infections and bacterial resistance. BMJ. 1998;317:654–657.
    1. Costelloe C, Metcalfe C, Lovering A, et al. . Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ. 2010;340:c2096.
    1. McNulty C, Richards J, Livermore DM, et al. . Clinical relevance of laboratory-reported antibiotic resistance in acute uncomplicated urinary tract infection in primary care. J Antimicrob Chemother. 2006;58:1000–1008.
    1. Bent S, Nallamothu B, Simel D.. Does this woman have an acute uncomplicated urinary tract infection? JAMA. 2002;287:2701–2710.
    1. Giesen L, Cousins G, Dimitrov BD, et al. . Predicting acute uncomplicated urinary tract infection in women: a systematic review of the diagnostic accuracy of symptoms and signs. BMC Fam Pract. 2010;11:78.
    1. Schmiemann G, Kniehl E, Gebhardt K, et al. . The diagnosis of urinary tract infection: a systematic review. Dtsch Arztebl Int. 2010;107:361–367.
    1. Flottorp S, Oxman AD, Cooper JG, et al. . Retningslinjer for diagnostikk og behandling av akutte vannlatingsplager hos kvinner (Guidelines for diagnosis and treatment of acute urinary tract problems in women). Tidsskr Den nor Laegeforening 2000;120:1748–1753.
    1. Scottish Intercollegiate Guidelines Network Scottish Intercollegiate Guidelines Network (SIGN). Management of suspected bacterial urinary tract infection in adults (SIGN publication no. 88). 2012.
    1. Bollestad M, Grude N, Lindbaek M.. A randomized controlled trial of a diagnostic algorithm for symptoms of uncomplicated cystitis at an out-of-hours service. Scand J Prim Health Care. 2015;33:57–64.
    1. Winkens R. Validity of the urine dipslide under daily practice conditions. Fam Pract. 2003;20:410–412.
    1. Ferry S, Burman L, Holm S. Uricult and sensicult dipslides for diagnosis of bacteriuria and prediction of drug resistance in primary health care. Scand J Prim Health Care. 1989;7:123–128.
    1. Blom M, Sørensen TL, Espersen F, et al. . Validation of FLEXICULT SSI-Urinary Kit for use in the primary health care setting. Scand J Infect Dis. 2002;34:430–435.
    1. Bongard E, Frimodt-Møller N, Gal M, et al. . Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing. Eur J Clin Microbiol Infect Dis. 2015;34:2111–2119.
    1. Gillespie T, Fewster J, Masterton RG.. The effect of specimen processing delay on borate urine preservation. J Clin Pathol. 1999;52:95–98.
    1. Nickander KK, Shanholtzer CJ, Peterson LR.. Urine culture transport tubes: Effect of sample volume on bacterial toxicity of the preservative. J Clin Microbiol 1982;15:593–595.
    1. Lauer BA, Reller LB, Mirrett S.. Evaluation of preservative fluid for urine collected for culture. J Clin Microbiol. 1979;10:42–45.
    1. Holm A, Cordoba G, Sørensen TM, et al. . Point of care susceptibility testing in primary care – does it lead to a more appropriate prescription of antibiotics in patients with uncomplicated urinary tract infections? Protocol for a randomized controlled trial. BMC Fam Pract. 2015;16:106.
    1. Holm A, Aabenhus R.. Urine sampling techniques in symptomatic primary-care patients: a diagnostic accuracy review. BMC Fam Pract. 2016;17:72.
    1. Aspevall O, Hallander H, Gant V, et al. . European guidelines for urinalysis: a collaborative document produced by European clinical microbiologists and clinical chemists under ECLM in collaboration with ESCMID. Scand J Clin Lab Invest. 2000;60:1–96.
    1. Leeflang MMG, Bossuyt PMM, Irwig L.. Diagnostic test accuracy may vary with prevalence: implications for evidence-based diagnosis. J Clin Epidemiol. 2009;62:5–12.
    1. Iversen J, Stendal G, Gerdes CM, et al. . Comparative evaluation of inoculation of urine samples with the Copan WASP and BD Kiestra inoqula instruments. J Clin Microbiol. 2016;54:328–332.
    1. Biesheuvel C, Irwig L, Bossuyt P.. Observed differences in diagnostic test accuracy between patient subgroups: is it real or due to reference standard misclassification? Clin Chem. 2007;53:1725–1729.
    1. Ferry SA, Holm SE, Ferry BM, et al. . High diagnostic accuracy of nitrite test paired with urine sediment can reduce unnecessary antibiotic therapy. Open Microbiology J. 2015;9:150–159.
    1. Bjerrum L, Grinsted P, Petersen PH, et al. . Standardised procedures can improve the validity of susceptibility testing of uropathogenic bacteria in general practice. Scand J Prim Health Care. 2000;18:242–246.
    1. Bates J, Thomas-Jones E, Pickles T, et al. . Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT™ informed management of uncomplicated UTI in primary care. BMC Fam Pract. 2014;15:187.

Source: PubMed

3
Subskrybuj