UC-3500: Sensitive and cost efficient albuminuruia screening
Literature Information
UC-3500: Sensitive and cost-efficient
albuminuria screening
Date: 15 June, 2017
Performance of the UC-3500 in terms of screening for
Subject:
albuminuria and proteinuria
Issued by: Integrated Marketing Urinalysis, Sysmex Europe GmbH
Number: 170615-AWV
UC-3500, test strips, evaluation, albuminuria screening, chronic
Keywords:
kidney disease (CKD)
Original article:
Delanghe JR, Himpe J, De Cock N, Delanghe S, De Herde K, Stove V, Speeckaert
MM.(2017): Sensitive albuminuria analysis using dye-binding based test strips. Clin Chim
Acta. 2017 May 26;471:107-112
http://www.sciencedirect.com/science/article/pii/S0009898117302218
Background:
Chronic kidney disease (CKD) is a growing global healthcare problem and it is
recommended that populations at risk, such as patients with diabetes or hypertension, are
screened for this disease regularly. Albuminuria is a marker for glomerular damage and
suitable for this purpose as it can indicate glomerular damage at a stage where it is still
reversible with appropriate therapeutic measures. To give more accurate results of the
albumin loss via the kidneys, the urinary albumin creatinine ratio (UACR) is assessed
using the parameter creatinine to compensate for the dilution of the urine sample.
Results:
For the evaluation, 177 urine samples were measured on the fully automated urine
chemistry analyser UC-3500 using the Meditape UC-11A test strips. Data analysis was
conducted based on the reflectance values because of ordinal scaled data.
Reproducibility was tested using the quality control material UC-Control high and low.
The results showed:
An excellent reproducibility described by within-run CV and between-run CV for
albumin and creatinine [see Table 1 ]
A strong positive correlation of the test strips with nephelometry for albumin
described by r= 0.92 [see Figure 1]
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UC-3500: Sensitive and cost efficient albuminuruia screening
An extremely low LOD value for albumin of 5.5 mg/L
An excellent correlation of the test strip with wet-chemistry method (Jaffe-based)
for creatinine described by r = 0.90 [see Figure 2]
A good correlation between test strip results and nephelometry/wet-chemistry-
results for urinary albumin creatinine ratio (UACR) of r = 0.59 [see Figure 3]
It is worth mentioning that interference by ascorbic acid was checked too. Ascorbic acid is
well-known as an interfering substance in chemistry analysis due to its reducing
character. As the test strips don’t include a test pad for ascorbic acid, the effect on the
albumin result was investigated in detail. An effect was only found at ascorbic acid
concentrations > 200 mg/L, which is extremely rare in clinical settings and therefore
neglectable.
Table 1 Within-run and between-run coefficients of variation (%) based on strip reflectance
data
Test Strip Meditape 11 A pH Creatinine Albumin
Within-run CV [%]
UC-Control L 1.20 0.71 0.21
UC-Control H 1.04 3.97 0.37
Between-run CV [%]
UC-Control L 1.12 0.93 0.24
UC-Control H 1.25 5.13 0.42
Figure 1 Regression analysis of urinary albumin (test strip) versus immunonephelometry:
log (y, test strip, 1/reflectance) = -2.0208 + 0.04535 log (x, immunonephelometry, mg/L) (n =
177, r = 0.92, P < 0.0001). The hollow circles represent specimens with albuminuria values
within the reference range; the filled circles represent specimen with albuminuria exceeding
the upper reference limit.
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Bornbarch 1, 22848 Norderstedt, Germany
Phone +49 (40) 527 26-0 Fax +49 (40) 527 26-100
[email protected] www.sysmex-europe.com
UC-3500: Sensitive and cost efficient albuminuruia screening
Figure 2 Regression analysis of urinary creatinine (test strip) against chemical analysis
(Jaffe method) on Cobas 8000 (Roche Diagnostics): y (test strip, 1/reflectance) = -0.01195 +
0.01638 log (x, Cobas 8000, mmol/L) (n = 124, r = 0.90, P < 0.0001)
Figure 3 Regression analysis of the urinary albumin/creatinine ratio (UACR, mg/g) of the
test strip against the UACR obtained by wet chemistry: log (y, test strip) = -0.1079 + 0.5903
log (x, Cobas 8000, mg/g) (n = 50, r = 0.59, P < 0.0001)
Sysmex Europe GmbH 3/4
Bornbarch 1, 22848 Norderstedt, Germany
Phone +49 (40) 527 26-0 Fax +49 (40) 527 26-100
[email protected] www.sysmex-europe.com
UC-3500: Sensitive and cost efficient albuminuruia screening
In a nutshell:
The parameters for albumin and creatinine on the UC-3500 show excellent
performance and allow reliable and cost-effective screening for albuminuria.
Due to the low LOD of albumin of 5.5 mg/L the clinically relevant lower limit of
20 mg/L can easily be covered. This test can therefore be used to differentiate
between normal and microalbuminuria-samples.
No relevant interference with ascorbic acid was identified.
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Bornbarch 1, 22848 Norderstedt, Germany
Phone +49 (40) 527 26-0 Fax +49 (40) 527 26-100
[email protected] www.sysmex-europe.com
