Performance Evaluation of the CLINITEK Novus Automated Urine Chemistry Analyzer

Jisook Yim; Sang-Guk Lee; Sunmi Cho; Young Cheol Won; Jeong-Ho Kim

doi:10.3343/lmo.2016.6.3.147

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Yim, Lee, Cho, Won, and Kim: Performance Evaluation of the CLINITEK Novus Automated Urine Chemistry Analyzer

Original Article

Laboratory Medicine Online 2016; 6(3): 147-151.

Published online: 1 July 2016

DOI: https://doi.org/10.3343/lmo.2016.6.3.147

Performance Evaluation of the CLINITEK Novus Automated Urine Chemistry Analyzer

Jisook Yim, M.D.¹, Sang-Guk Lee, M.D.¹, Sunmi Cho, M.D.², Young Cheol Won, M.T.¹, Jeong-Ho Kim, M.D.¹

¹Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea.

²Department of Laboratory Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.

Corresponding author: Jeong-Ho Kim. Department of Laboratory Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea. Tel: +82-2-2228-2448, Fax: +82-2-364-1583, jeongho@yuhs.ac

Received 23 June 2015 Revised 22 January 2016 Accepted 25 January 2016

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

We aimed to evaluate the performance of the CLINITEK Novus urine chemistry analyzer (Siemens, UK).

Methods

The precision, correlation, and carryover study were performed using two kinds of commercial quality control materials and 40-55 freshly collected patient specimens. We calculated exact and within-1-block agreement, along with kappa agreement, to compare the semi-quantitative results between urine chemistry analyzers. The urine specific gravity taken by a refractometer was compared with the analyzer results. Moreover, we analyzed additional urine specimens for protein to evaluate the agreement of results between those of the CLINITEK Novus and the AU680 analyzers (Beckman Coulter, Japan).

Results

The precision study showed acceptable results; within-1-block agreement was 100% in all tested items. The urine chemistry results from the CLNITEK Novus analyzer demonstrated ≥85.1% within-1-block agreements with those of the Uriscan Super, and the kappa test results were ≥0.81. The comparison of specific gravity with manual refractometer showed a good correlation (r=0.991), and the protein comparison with the AU680 analyzer also showed a good correlation (with exact and within-1-block agreements being 75.9% and 100.0%, respectively). The carryover rates were 0% in all tested items, except specific gravity and heavy blood tests.

Conclusions

The CLINITEK Novus analyzer showed good performance in terms of precision, comparison, and carryover in this study. Therefore, the CLINITEK Novus automated urine analysis is expected to be useful for routine urinalysis in a clinical laboratory.

Keywords: Performance evaluation, Automated urinalysis, CLINITEK Novus

Figures and Tables

Fig. 1

Agreement and correlation of specific gravity between (A) the CLINITEK Novus analyzer and a refractometer, (B) Uriscan Super and a refractometer, (C) CLINITEK Novus and Uriscan Super.

Table 1

Semiquantitative level grading criteria for the CLINITEK Novus and Uriscan Super analyzers according to their package inserts

	Instrument	Negative	±	1+	2+	3+	4+	Unit
Protein	CLINITEK Novus	-	-	30	100	300	2,000	mg/dL
Protein	Uriscan Super	-	10	30	100	300	1,000	mg/dL
Glucose	CLINITEK Novus	-	100	250	500	1,000	2,000	mg/dL
Glucose	Uriscan Super	-	100	250	500	1,000	2,000	mg/dL
Ketone	CLINITEK Novus	-	5	15	40	80	160	mg/dL
Ketone	Uriscan Super	-	5	10	50	100	-	mg/dL
Occult blood	CLINITEK Novus	-	Trace	Small	Moderate	Large	-	-
Occult blood	Uriscan Super	-	-	10	50	250	-	RBC/µL
Leukocytes	CLINITEK Novus	-	Trace	Small	Moderate	Large	-	-
Leukocytes	Uriscan Super	-	-	25	75	500	-	WBC/µL

Table 2

Precision analyzed by the CLINITEK Novus analyzer using CLINITEK Novus Control Strips and Liquichek Urinalysis Controls for 11 test parameters (N=20)

Strips	Bilirubin	Occult blood	Agreement (%), Exact agreement/within-1-block agreement
Strips	Bilirubin	Occult blood	Clarity	Color	Glucose	Ketone	WBCs	Nitrite	pH	Protein	Urobilinogen
NOVUS CONTROLS Level 1	100/100	100/100	100/100	100/100	100/100	100/100	100/100	100/100	100/100	100/100	100/100
Liquichek Level 1	100/100	100/100	-^*	-^*	100/100	100/100	100/100	100/100	100/100	100/100	100/100
NOVUS CONTROLS Level 2	100/100	100/100	100/100	100/100	100/100	85/100	95/100	100/100	100/100	65/100	100/100
Liquichek Level 2	100/100	100/100	^-*	^-*	70/100	65/100	100/100	100/100	100/100	60/100	100/100

^*Liquichek controls have no items for clarity and color.

Table 3

Precision of specific gravity analyzed by the CLINITEK Novus analyzer

Test	Material	Expected value	Mean	SD	%CV
Specific gravity	NOVUS CONTROLS Level 1	≤ 1.006	1.002	0.0009	0.090
Specific gravity	Liquicheck Level 1	1.005-1.020	1.013	0.0009	0.001
	NOVUS CONTROLS Level 2	1.004-1.014	1.010	0.0014	0.139
	Liquicheck Level 2	1.015-1.030	1.022	0.0011	0.108

Table 4

Agreement percentages and kappa values of protein, glucose, ketone, occult blood, leukocytes, and pH using the CLINITEK Novus and Uriscan Super analyzers

	Sample no.	Complete agreement (%)	Within-1-block agreement (%)	Positive/negative agreement (%)	κ
Protein	47	40.4	85.1	100.0	0.81
Glucose	55	54.6	94.6	94.5	0.90
Ketone	43	72.1	100.0	95.3	0.93
Occult blood	40	80.0	100.0	97.5	0.96
Leukocytes	50	68.0	100.0	90.0	0.91
pH	41	41.5	97.6	-	0.91

Table 5

Agreement of urine protein between the CLINITEK Novus analyzer and quantitation by the AU680 analyzer (grade, N=29)

CLINITEK Novus	AU680^*
CLINITEK Novus	Negative	±	1+	2+	3+	4+
Negative	6	1
±		3
1+			5	1
2+			2	4	2
3+					4	1
4+

Complete agreement: 75.9%; Within-1-block agreement: 100.0%; Positive/negative agreement: 100.0%; Kappa test: 0.94. ^*Protein concentrations measured by the AU680 analyzer were graded according to the dipstick package insert (Siemens, NY, USA), grade (equivalent concentration); Negative, ±, 1+(30 mg/dL), 2+(100 mg/dL), 3+(300 mg/dL), 4+(2,000 mg/dL).

Notes

This article is available from http://www.labmedonline.org

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