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Urinalysis Vs Urine Protein–Creatinine Ratio to Predict Significant Journal of Perinatology (2008) 28, 461–467 r 2008 Nature Publishing Group All rights reserved. 0743-8346/08 $30 www.nature.com/jp ORIGINAL ARTICLE Urinalysis vs urine protein–creatinine ratio to predict significant proteinuria in pregnancy BK Dwyer1, M Gorman2, IR Carroll3 and M Druzin1 1Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Stanford University, Stanford, CA, USA; 2Department of Family and Community Medicine, University of California, Davis, CA, USA and 3Division of Pain Medicine, Department of Anesthesiology, Stanford University, Stanford, CA, USA evaluation. A rapid screening test to predict 24-h proteinuria, in Objective: To compare the urine protein–creatinine ratio with urinalysis combination with other presenting signs and symptoms, can help a to predict significant proteinuria (X300 mg per day). clinician determine the appropriate amount of surveillance and Study Design: A total of 116 paired spot urine samples and 24-h urine guide care during the initial 24-h period. Traditionally, the dipstick 2 collections were obtained prospectively from women at risk for urinalysis has been used as this screening test. preeclampsia. Urine protein–creatinine ratio and urinalysis were The dipstick urinalysis measures the concentration of protein in compared to the 24-h urine collection. the urine and is susceptible to fluctuations in the water content of the urine. Dilute urine may underestimate the amount of protein Result: The urine protein–creatinine ratio had better discriminatory that would be collected in a 24-h urine collection, whereas power than urinalysis: the receiver operating characteristic curve had a concentrated urine may overestimate it. Prior studies have reported greater area under the curve, 0.89 (95% confidence interval (CI) 0.83 to that dipstick urinalysis has varying degrees of accuracy, with 0.95) vs 0.71 (95% CI 0.64 to 0.77, P<0.001). When matched for sensitivities ranging from 22 to 82%. Specificities also vary clinically relevant specificity, urine protein–creatinine ratio (cutoff widely.2–5 Differences in methodology contribute to this large X0.28) is more sensitive than urinalysis (cutoff X1 þ ): 66 vs 41%, discrepancy. For example, automated dipstick urinalysis is more P ¼ 0.001 (with 95 and 100% specificity, respectively). Furthermore, the specific for predicting 24-h proteinuria than is ward dipstick urine protein–creatinine ratio predicted the absence or presence of urinalysis.6 Furthermore, discrepancies in the reported sensitivity proteinuria in 64% of patients; urinalysis predicted this in only 19%. and specificity of the dipstick urinalysis may be due to differences Conclusion: The urine protein–creatinine ratio is a better screening in the spectrum of illness in the populations studied or the time of test. It provides early information for more patients. day that the spot urine was collected. Journal of Perinatology (2008) 28, 461–467; doi:10.1038/jp.2008.4; Recently, the urine protein–creatinine ratio has been published online 21 February 2008 considered important for predicting proteinuria. It compares the spot urine protein excretion to the spot urine creatinine excretion, Keywords: pregnancy; urinalysis; urine protein–creatinine ratio; proteinuria; preeclampsia; sensitivity and specificity thereby normalizing protein excretion to the glomerular filtration rate. Thus, the urine protein–creatinine ratio is not subject to variation due to hydration status. In pregnant women, the urine protein–creatinine ratio and the 24-h urine are highly Introduction correlated.6–13 Many studies have evaluated the urine protein– The diagnosis of preeclampsia is determined by the presence of creatinine ratio but, they differ in their recommended cutoffs and elevated blood pressure and significant proteinuria (X300 mg per 6–9,12,13 1 differ in their assessment of the test’s utility. Different 24 h) after the 20th week of gestation. The gold standard for methodologies, such as the spectrum of illness in the population measuring proteinuria is the 24-h urine collection. Unfortunately, studied, retrospective study design,9 exclusion of patients with the 24-h urine collection takes an entire day to collect and is, comorbid illness,9,13 and nonexclusion of incomplete or infected therefore, not available to guide clinical decisions upon first samples6–13 probably account for these discrepancies. Correspondence: Dr BK Dwyer, Division of Maternal Fetal Medicine, Department of No study has directly compared the diagnostic ability of the Gynecology and Obstetrics, Stanford University, 300 Pasteur Drive, Stanford, CA 94305-5317, automated dipstick urinalysis to that of the urine protein– USA. creatinine ratio using the same group of subjects, which would E-mail: [email protected] Received 4 June 2007; revised 19 December 2007; accepted 4 January 2008; published online allow appropriate statistical comparisons. In this study, we directly 21 February 2008 compared the two tests in a prospective fashion on a group of Urinalysis and protein–creatinine ratio BK Dwyer et al 462 women being evaluated for preeclampsia, including those with respectively. The automated dipstick urinalysis was performed with comorbid illness to determine which was more predictive of 24-h Iris test strips and either the IRIS 500 (IRIS Inc., Chatsworth, CA, proteinuria. USA) or Autionmax (Arcray Inc., Kyoto, Japan), autoanalyzers using 3030050500-tetrachlorophenol-3,4,5,6-tetrabromosulfopthalein, a protein error of pH indicator. These machines were calibrated Methods such that 1 þ protein ¼ 30 mg per 100 ml, 2 þ protein ¼ 100 mg This prospective study was performed on the Labor and Delivery per 100 ml, 3 þ protein ¼ 300 mg per 100 ml and unit at Stanford University Hospital from September 2002 to March 4 þ protein ¼ 1000 mg per 100 ml. Trace protein was not reported 2004 after approval by the Institutional Review Board, Medical by these machines. All measurements were performed by laboratory Human Subjects Panel. Written informed consent was obtained technicians blinded to the clinical status of the study patients. from all participating patients. To mimic the experience of treating physicians we included all women being evaluated for Statistical analysis preeclampsia, regardless of the alerting sign or symptom, suspected The strengths of the correlation between the automated dipstick severity or comorbid conditions. Study patients underwent initial urinalysis and 24-h proteinuria and the urine protein–creatinine triage on the Labor and Delivery unit. Most women completed the ratio and 24-h proteinuria were determined by Spearman’s correlation 24-h urine collection as outpatients, but some remained in the unit coefficients with corresponding 95% confidence intervals (CI). as clinically indicated. The study design allowed for patients to be Significant proteinuria was defined as X300 mg of protein in enrolled when they presented to Labor and Delivery for an the 24-h urine collection, as recommended by the International independent evaluation of preeclampsia. Therefore, women could Society for the Study of Hypertension in Pregnancy and the 1,15 be enrolled more than once. There were 155 enrollments. Of these, American College of Obstetrics and Gynecology. The sensitivity 16 19 were excluded because the 24-h urine was not done, 4 because and specificity as well as the positive and negative predictive 17 the urinalysis was not done and 6 because the urine protein– values were calculated using each observed level of the urinalysis creatinine ratio was not done. Six were excluded because the 24-h and the urine protein–creatinine ratio as the threshold for a urine was not complete or the collection was improper by the positive test with the 24-h collection as the reference standard. criteria below. Four were excluded because the urinalysis had>10 Differences in selected sensitivities and specificities were examined white blood cells (WBCs) per high-power field (h.p.f.) on using the McNemar’s test. The likelihood ratios (LRs) for ranges of 18 microscopy, concerning for contamination. A total of 116 the urine protein–creatinine ratio and urinalysis were calculated. enrollments from 95 women were ultimately included in the study. Additionally, we examined the test characteristics for predicting a Thus, 21 of the 116 samples were from women who were enrolled severe level of proteinuria of 5000 mg or greater. in the study more than once. The relationship between sensitivity and the false-positive rate The main measures were the urinary protein concentration (1Àspecificity) for both the urinalysis and the urine protein– by automated dipstick urinalysis, the urinary protein to urinary creatinine ratio was evaluated by constructing receiver operating creatinine ratio by random (spot) direct measurement and the characteristic (ROC) curves for both measures. As a summary of 24-h urinary protein excretion by a 24-h urine collection. The the diagnostic utility of the urinalysis and the urine protein– urinalysis and the urine protein–creatinine ratio were usually creatinine ratio, the areas under the ROC curves were calculated obtained immediately before the 24-h urine collection was begun. and directly compared using the method described by Delong 19 If that sample was not available at the time of enrollment, a et al. Data analysis was performed using STATA statistical sample was obtained immediately after the 24-h collection. All software (Release 8; Stata Corp., College Station, TX, USA). samples were collected via clean catch unless the
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