Evaluation of iQ200 Automated Urine Microscopy Analyzer

Joowon Park; Jongwan Kim

doi:10.3343/kjlm.2008.28.4.267

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Park and Kim: Evaluation of iQ200 Automated Urine Microscopy Analyzer

Original Article

Korean J Leg Med 2008;28(4):267-273.

Published online: 14 February 2008

DOI: https://doi.org/10.3343/kjlm.2008.28.4.267

Evaluation of iQ200 Automated Urine Microscopy Analyzer

Joowon Park, M.D., Jongwan Kim, M.D.

Department of Laboratory Medicine, Dankook University College of Medicine, Cheonan, Korea

Received 7 December 20074 July 2008 Accepted 8 July 2008

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Microscopic examination of urine sediment is one of the most commonly performed tests in the clinical laboratory. However, manual microscopic sediment examination is labor-intensive, time-consuming and imprecise. In this study, we evaluated the analytical performance and clinical usefulness of a recently introduced image-based automated urinalysis system, Iris iQ200 (Iris Diagnostics, USA).

Methods

We assessed the iQ200 for linearity, precision and carryover rate using patient's samples and quality control materials. On 337 urine samples, urine sediment analyses performed by the iQ200 were compared with manual microscopy results.

Results

The iQ200 showed a good linearity (r²>0.99) for all cellular components analyzed. Within-run and total CVs on urine specimens and quality control samples were less than 10% except for within-run CV for the samples with low concentration of the squamous epithelial cells. The carryover rates were 0.21% for RBCs and 1.92% for WBCs. The agreement rates within one grade between the iQ200 and manual microscopy for RBCs, WBCs, and squamous epithelial cells were 93.8%, 94.2% and 96.9%, respectively.

Conclusions

Since the iQ200 showed a reliable analytical performance and good concordance with manual microscopy, it could be useful in the clinical practice as a screening procedure.

Keywords: iQ200, Automated urinalysis, Urine sediment

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Fig. 1.

Linearities of RBCs (A), WBCs (B), squamous epithelial cells (C), and preserved RBCs (D) analyzed by iQ200.

Table 1.

Grading system of DKUH for urine microscopy

	Cells/HPF
Grade 1	<1
Grade 2	1-4
Grade 3	5-9
Grade 4	10-29
Grade 5	30-1/2 of field of view
Grade 6	>1/2 of field of view

Abbreviations: DKUH, Dankook university hospital; HPF, high power field.

Table 2.

Precision of iQ200 on pooled urine specimens

Cell type	N	Mean (counts/μL)	SD	Within-run CV (%)
RBCs	30	34	2.9	8.3
	30	85	3.9	4.6
	30	240	5.3	2.3
WBCs	30	38	3.2	7.8
	30	90	4.3	4.7
	30	183	6.6	3.7
SECs	30	21	2.3	10.6
	30	72	5.4	7.7

Abbreviation: SECs, squamous epithelial cells.

Table 3.

Precision of iQ200 on quality control samples

Level	N	Mean (counts/μL)	SD	CV (%)
Level	N	Mean (counts/μL)	SD	Within-run	Total
Low	80	50.1	3.7	7.39	8.46
Middle	80	499.5	9.3	1.87	2.04
High	80	1002.1	8.0	0.80	0.97

Table 4.

Performance of iQ200 in comparison with manual microscopy

Cell type	N. tested	N (%)
Cell type	N. tested	HI	LI	Agreement^∗
RBCs	325	13 (4.0)	7 (2.2)	305 (93.8)
WBCs	325	17 (5.2)	2 (0.6)	306 (94.2)
SECs	325	3 (0.9)	7 (2.2)	315 (96.9)

^∗ Data includes the number of cases within one grading difference.

Abbreviations: HI, Higher iQ200 cases with two or more grades than manual microscopy; LI, Lower iQ200 cases with two or more grades than manual microscopy; SECs, squamous epithelial cells.

Table 5.

Summary of RBC results between iQ200 and manual microscopy

iQ200 grading	Manual microscopy grading (DKUH)
iQ200 grading	1+	2+	3+	4+	5+	6+	Sum
1+	88						88
2+	31	21	19	2			73
3+	4	12	20	17	1		54
4+	1	3	3	20	4	4	35
5+		1	1	12	6	11	31
6+				3	4	37	44
Sum	124	37	43	54	15	52	325

Abbreviation: DKUH, Dankook university hospital.

Table 6.

Summary of WBC results between iQ200 and manual microscopy

iQ200 grading	Manual microscopy grading (DKUH)
iQ200 grading	1+	2+	3+	4+	5+	6+	Sum
1+	61	1					62
2+	65	29	2				96
3+	5	60	28	15	1		109
4+	1	4	4	17	3	1	30
5+		2	3	7	4	2	18
6+				2	3	5	10
Sum	132	96	37	41	11	8	325

Abbreviation: DKUH, Dankook university hospital.

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