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Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing

Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing
Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing
Currently available point-of-care (POC) diagnostic tests for managing urinary tract infections (UTIs) in general practice are limited by poor performance characteristics, and laboratory culture generally provides results only after a few days. This laboratory evaluation compared the analytic performance of the POC UK Flexicult? (Statens Serum Institut) (SSI) urinary kit for quantification, identification and antibiotic susceptibility testing and routine UK National Health Service (NHS) urine processing to an advanced urine culture method. Two hundred urine samples routinely submitted to the Public Health Wales Microbiology Laboratory were divided and: (1) analysed by routine NHS microbiological tests as per local laboratory standard operating procedures, (2) inoculated onto the UK Flexicult? SSI urinary kit and (3) spiral plated onto Colorex Orientation UTI medium (EO Laboratories Ltd). The results were evaluated between the NHS and Flexicult? methods, and discordant results were compared to the spiral plating method. The UK Flexicult? SSI urinary kit was compared to routine NHS culture for identification of a pure or predominant uropathogen at ?105 cfu/mL, with a positive discordancy rate of 13.5 % and a negative discordancy rate of 3 The sensitivity and specificity were 86.7 % [95 % confidence interval (CI) 73.8?93.7] and 82.6 % (95 % CI 75.8?87.7), respectively. The UK Flexicult? SSI urinary kit was comparable to routine NHS urine processing in identifying microbiologically positive UTIs in this laboratory evaluation. However, the number of false-positive samples could lead to over-prescribing of antibiotics in clinical practice. The Flexicult? SSI kit could be useful as a POC test for UTIs in primary care but further pragmatic evaluations are necessary.
0934-9723
2111-2119
Bongard, E.
498cda67-5b1a-4f3a-98f1-9c2b01c48410
Frimodt-Møller, N.
3dfb9053-98c2-41a0-87c5-bebff8c06194
Gal, M.
49434557-9212-4376-9f60-63b4df70dcb2
Wootton, M.
95cc08ff-6847-404b-96f8-df031c3ebfaa
Howe, R.
bfb0b8b8-eaca-4638-8444-81a48a395d8d
Francis, Nicholas Andrew
9b610883-605c-4fee-871d-defaa86ccf8e
Goossens, H.
533640f7-b568-4d95-a7c1-28158d154ba8
Butler, Christopher Collett
d2f9102c-54c2-4570-be4e-32324c8c8f1d
Bongard, E.
498cda67-5b1a-4f3a-98f1-9c2b01c48410
Frimodt-Møller, N.
3dfb9053-98c2-41a0-87c5-bebff8c06194
Gal, M.
49434557-9212-4376-9f60-63b4df70dcb2
Wootton, M.
95cc08ff-6847-404b-96f8-df031c3ebfaa
Howe, R.
bfb0b8b8-eaca-4638-8444-81a48a395d8d
Francis, Nicholas Andrew
9b610883-605c-4fee-871d-defaa86ccf8e
Goossens, H.
533640f7-b568-4d95-a7c1-28158d154ba8
Butler, Christopher Collett
d2f9102c-54c2-4570-be4e-32324c8c8f1d

Bongard, E., Frimodt-Møller, N., Gal, M., Wootton, M., Howe, R., Francis, Nicholas Andrew, Goossens, H. and Butler, Christopher Collett (2015) Analytic laboratory performance of a point of care urine culture kit for diagnosis and antibiotic susceptibility testing. European Journal of Clinical Microbiology & Infectious Diseases, 34 (10), 2111-2119. (doi:10.1007/s10096-015-2460-4).

Record type: Article

Abstract

Currently available point-of-care (POC) diagnostic tests for managing urinary tract infections (UTIs) in general practice are limited by poor performance characteristics, and laboratory culture generally provides results only after a few days. This laboratory evaluation compared the analytic performance of the POC UK Flexicult? (Statens Serum Institut) (SSI) urinary kit for quantification, identification and antibiotic susceptibility testing and routine UK National Health Service (NHS) urine processing to an advanced urine culture method. Two hundred urine samples routinely submitted to the Public Health Wales Microbiology Laboratory were divided and: (1) analysed by routine NHS microbiological tests as per local laboratory standard operating procedures, (2) inoculated onto the UK Flexicult? SSI urinary kit and (3) spiral plated onto Colorex Orientation UTI medium (EO Laboratories Ltd). The results were evaluated between the NHS and Flexicult? methods, and discordant results were compared to the spiral plating method. The UK Flexicult? SSI urinary kit was compared to routine NHS culture for identification of a pure or predominant uropathogen at ?105 cfu/mL, with a positive discordancy rate of 13.5 % and a negative discordancy rate of 3 The sensitivity and specificity were 86.7 % [95 % confidence interval (CI) 73.8?93.7] and 82.6 % (95 % CI 75.8?87.7), respectively. The UK Flexicult? SSI urinary kit was comparable to routine NHS urine processing in identifying microbiologically positive UTIs in this laboratory evaluation. However, the number of false-positive samples could lead to over-prescribing of antibiotics in clinical practice. The Flexicult? SSI kit could be useful as a POC test for UTIs in primary care but further pragmatic evaluations are necessary.

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More information

Accepted/In Press date: 16 July 2015
e-pub ahead of print date: 6 August 2015
Published date: 1 October 2015

Identifiers

Local EPrints ID: 435846
URI: http://eprints.soton.ac.uk/id/eprint/435846
ISSN: 0934-9723
PURE UUID: 3a3eefcd-50dd-4eb7-b2a8-42070c3f36ad
ORCID for Nicholas Andrew Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 21 Nov 2019 17:30
Last modified: 03 Dec 2019 01:20

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