Urine Dipstick Research Articles

Urinary calprotectin as a diagnostic tool for detecting significant bacteriuria

Pyuria in dipstick examination serves as the most widespread screening tool for urinary tract infections (UTI). The absence of pyuria, however, does not exclude UTI. We investigated the diagnostic value of urinary calprotectin, a mediator protein of the innate immune system, which is released by leukocytes, for the detection of UTI and compared it with dipstick pyuria. Since even low numbers of leukocytes in the urine significantly increase urinary calprotectin concentrations, calprotectin might be a more sensitive marker than pyuria detected by dipstick. All 162 patients were prospectively included and underwent a urine dipstick, urine culture, quantification of proteinuria and determination of calprotectin in the urine. Urinary calprotectin was determined using an enzyme-linked immunosorbent assay (ELISA). UTI was defined as urine cultures with detection of one or a maximum of two uropathogenic bacteria with ≥ 105 colony-forming units per millilitre (CFU/ml). Exclusion criteria were acute kidney injury, chronic renal insufficiency and tumors of the urinary tract. 71 (43.8%) patients had a UTI. Of the 91 patients without UTI, 23 had a contamination and 19 had evidence of ≥ 105 CFU/ml considered to be asymptomatic bacteriuria. The median calprotectin concentration in patients with UTI and pyuria was significantly higher than in patients with UTI and without pyuria (5510.4 vs. 544.7 ng/ml). In ROC analyses, calprotectin revealed an area under the curve (AUC) of 0.70 for the detection of significant bacteriuria. Pyuria in dipstick examinations provided an AUC of 0.71. There was no significant difference between these AUCs in the DeLong test (p = 0.9). In patients with evidence of significant bacteriuria but without pyuria, a significantly higher calprotectin concentration was measured in the urine than in patients with neither pyuria nor UTI (544.7 ng/ml vs 95.6 ng/ml, p = 0.029). Urinary calprotectin is non-inferior to dipstick pyuria in the detection of UTI.

Proteinuria and risk of ocular motor cranial nerve palsy: a nationwide population-based study

Understanding the association between dipstick-detected proteinuria and oculomotor cranial nerve palsy (CNP) could have significant implications for understanding the mechanism of CNP development and for developing preventive strategies against CNP development in patients with proteinuria. This study aimed to determine the relationship between dipstick-determined proteinuria and ocular motor CNP using National Sample Cohort (NSC) database from Korea’s National Health Insurance Service (NHIS). A nationwide population-based cohort study was conducted using data from the NSC database of Korea’s NHIS. These data were collected from 2009 to 2018. A one-year time lag was established to prevent a situation in which the causal link was inverted. Participants aged 20 years or more who were diagnosed with proteinuria in 2009 were included. Individuals with specific pre-existing CNP, missing data, and those who were newly diagnosed with CNP or who died within one year of being tested were excluded. The study population was classified into six groups according to the degree of proteinuria (negative, trace, or between 1 + and 4 +) based on the urine dipstick test. A Cox proportional hazard regression analysis was performed to determine the linkage between the degree of proteinuria and ocular motor CNP. A total of 5,807 (0.14% of subjects) with ocular motor CNP were assigned to the ocular motor CNP group and 4,047,205 subjects were assigned to the control group. After full adjustment of comorbidities, hazard ratios (HRs) for 1 + , 2 + , 3 + and 4 + proteinuria groups were 1.449 (95% confidence interval [CI] 1.244–1.687), 2.081 (1.707–2.538), 1.96 (1.322–2.904), and 3.011 (1.507–6.014), respectively, for developing ocular motor CNP compared to the proteinuria-negative group. In subgroup analysis, the HR of patients with proteinuria for the development of ocular motor CNP was higher in the younger age group (less than 40 years) (P = 0.0242) and the group with DM (P = 0.04). Our population-based cohort study demonstrated a significant association between proteinuria and the incidence of CNP, suggesting that urine protein level could be a new clinical marker for predicting the development of CNP.

Accuracy of screening for hemolysis in plasma samples using a commercial urine dipstick

Objectives: Identification and quantification of hemolysis in serum or plasma samples is an important requirement in laboratory diagnostics; however, this is not always possible automatically, and visual sample inspection is not sufficiently accurate. We have planned this study to determine whether a commercially available urine dipstick with a hemoglobin-reactive pad could be used for this purpose. Materials and Methods: Sixty-five routine plasma samples, whose hemolysis index (HI) was previously determined on Roche Cobas 8000, were assayed with a commercial urine dipstick to obtain semi-quantitative data on plasma hemoglobin. Plasma was diluted 1:1000 in water to enter the dipstick’s range of hemoglobin measurement, and 10 µL of this dilution was applied to the hemoglobin pad. Results were visually interpreted within 60 s by comparing the pad color with that on the dipstick box label. Statistical Analysis: Semi-quantitative test results obtained with the urine dipstick were directly correlated with those of the same samples assayed on Roche Cobas 8000 using non-parametric Spearman’s correlation and agreement. Results: The sample size consisted of 40 non-hemolyzed (HI ≤0.3 g/L) and 25 hemolyzed (HI >0.3 g/L) plasma samples. Spearman’s correlation between Cobas HI and dipstick hemoglobin concentration was r = 0.96 (95% confidence interval, 0.93–0.97; P < 0.001). The concordance of hemolysis detection was 95.4%, with 1.00 sensitivity, 0.93 specificity, 1.00 negative predictive value, and 0.89 positive predictive value compared to the reference HI measurement on Cobas. The cumulative agreement between Cobas HI and the various plasma hemoglobin thresholds obtained with the dipstick was 75.4%. Conclusions: We have demonstrated here that plasma hemoglobin assessment with commercially available urine dipsticks may generate semi-quantitative test results accurate enough to influence decision-making regarding sample quality and its suitability for testing.

#2356 Renal function in pediatric general population from a hot-spot of chronic kidney disease of unknown etiology: a cross-sectional study in Guatemala

Abstract Background and Aims Chronic kidney disease of unknown etiology incidence has been exponentially increasing in Central America. Subclinical kidney injury begins early in life and leads to a higher-than-expected prevalence of chronic kidney disease in adolescents and children. The pediatric population has not had a specific approach to the community with this type of kidney disease and very little data is known in Guatemala. We aim to estimate the glomerular filtration rate (eGFR) using two serum biomarkers (creatinine and cystatin C) and applying the Under 25 equation. Inflammatory and urine biomarkers (Urinary Neutrophil Gelatinase-Associated Lipocalin, albumin/creatinine ratio, and urine dipstick) were determined. Method During 2019, we performed a Cross-Sectional, population-based screening study in children and adolescents between 7-17 years of age, from local schools in a highly CKDu incident rural community in the Pacific Coast of Guatemala. Children with a diagnosis of kidney disease, hepatic and cardiac failure were excluded in the study. Subjects were chosen randomly from 10 different schools and renal function markers were analyzed by sex and age. Results Out of 97 participants of La Democracia, the median age was 11 years and 57% were male. Eighty-seven percent (81/97) of participants had an eGFR between 60 and 90 mL/min/1.73 m2 (Table 1). When comparing eGFR by sex, 63% (51/81) of males and 37% of females had an eGFR between 60 and 90 mL/min/1.73 m2. The difference was statistically significant (p 0.05). When comparing eGFR by age group, the scholar group had an eGFR of 82.7 mL/min/1.73 m2 (SD 7.9), pre-scholars eGFR of 82.2 mL/min/1.73 m2 (SD 6.3), and adolescents of 81.5 (SD 8.1) with no statistically significant difference (p 0.83). Among the twenty-four percent of participants who presented urine dipstick abnormalities, leukocyturia represented 23% (22/97). Twenty-two percent (21/97) of participants had albuminuria more than 0.2 mg/mg and the urinary NGAL/creatinine ratio was higher in females. Conclusion

#3096 Exploratory population-based screening of kidney function and heavy metal water source levels in a highly incident CKDu area in Guatemala

Abstract Background and Aims Chronic kidney disease of unknown etiology (CKDu) has exponentially increased in the rural areas of the Pacific Coast in Central America. A multifactorial etiology has been postulated including exposure to environmental nephrotoxins such as heavy metals. The Pacific Coast of Guatemala has a volcanic topography with a high content of heavy metals, and the rural communities use ground water as their regular drinking consumption. Since the highest age group affected by CKDu are young adults, we postulated an exposure during childhood impacting later in life. We aim to identify changes in kidney function in children and adolescent healthy population from a highly incident CKDu area, and the heavy metal levels from water sources as a hypothesis generation exploratory study. Method We performed a population-based cross-sectional study of children and adolescents (below 17 y/o) from La Democracia municipality that were randomly chosen using Epidat software 3.1 from 10 different local schools from March 2019 to March 2020. The study was approved by external ethics board committee external-independent research ethics board committee. Subjects were excluded if they had known diagnosis of CKD, kidney replacement therapy or hypertension. The screening was performed in three different steps including a background assessment questionnaire, clinical assessment, and biochemical testing including creatinine from blood drop using StatSensor XpressTM to calculate estimated glomerular filtration rate (eGFR), urine dipstick, urinary creatinine, and protein. We measured arsenic (33As), cadmium (48Cd), mercury (80Hg), and lead (82Pb) in 21 water wells around the 10 screened schools, while only arsenic (33As), cadmium (48Cd) and mercury (80Hg) were measured in the urine of a small subset of the samples (data not shown in the results). Results A total of 508 randomly selected subjects’ and parents’ consent for screening but only 506 completed assessment. The median age was 14 y/o (IQR 11-17) 50% being female, with a close to 30% of the sample having obesity. The blood pressure was abnormal in 28% of the sample and at least 30% of them had an abnormal urine dipstick. The overall eGFR was 98, being the 25th%tile close to 83 ml/min/1.73 m2 BSA (Tables 1 and 2). Water sources showed higher than recommended levels of all heavy metals tested. Interestingly, the schools “Campiña” showed high levels of Arsenic and Cadmium in water sources, being the subjects tested coincidentally among the lowest eGFR of sample. Conclusion CKDu is an entity devastating low-resourced communities with young adults being the most affected. A likelihood for a link of early exposure needs to be further explored. Addressing the postulated hypothesis are key to implement preventive strategies, including screening earlier in life such as pediatric population.

#812 Phase 2b ORIGIN study open label extension with atacicept in patients with IgA nephropathy and persistent proteinuria: week 72 interim analysis

Abstract Background and Aims IgA nephropathy (IgAN), the most common primary glomerulonephritis and a significant contributor to ESKD worldwide, is characterized by elevated serum levels of galactose-deficient IgA1 (Gd-IgA1). The production of Gd-IgA1 and its autoantibodies is driven by both the B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL) signaling pathways that stimulate maturation, differentiation, and effector function of B cells and plasma cells. Atacicept is a fusion protein targeting both BAFF and APRIL in clinical development for IgAN treatment. The Phase 2b ORIGIN study met the primary endpoint with statistically significant urine protein:creatinine ratio (UPCR) reduction at 24 weeks vs placebo. At 36 weeks, atacicept 150 mg achieved statistically significant and clinically meaningful UPCR reduction, eGFR stabilization, and Gd-IgA1 reduction vs placebo, with similar safety to placebo. This interim analysis reports 72-week results from the open-label extension period. Method The randomized, double-blind, placebo-controlled Phase 2b ORIGIN study included 116 participants with biopsy-proven IgAN, 24 h urine protein >0.75 g/day or UPCR >0.75 g/g, and eGFR ≥30 mL/min/1.73 m2 despite optimized renin–angiotensin system blockade. Participants were randomized to atacicept 150, 75, or 25 mg, vs placebo (2:2:1:2), self-administered by subcutaneous injection once weekly for up to 36 weeks. The double-blind randomized treatment period was followed by an open-label extension in which participants could receive atacicept 150 mg for up to 60 additional weeks, for a total of 96 weeks. For this interim analysis, changes from baseline in eGFR, natural log transformed UPCR, and Gd-IgA1 through 72 weeks were analyzed using a mixed-effects model for repeated measurements. Microscopic hematuria was evaluated on urine dipstick and participants with hematuria grade 1+ or higher at baseline were evaluated for resolution, defined as a decrease to negative/trace, at 72 weeks. Results Of 116 randomized participants in the double-blind period, 106 participants (91%) completed 72 weeks of treatment. At 72 weeks, eGFR total slope estimate was 0.0 mL/min/1.73m2/year and eGFR change from baseline was 0 mL/min/1.73m2 in all participants originally randomized to atacicept (all-atacicept group; n = 82). After switching to open-label atacicept 150 mg, the original placebo group showed eGFR stabilization with −3.2 mL/min/1.73m2 change from baseline at 72 weeks vs −4.9 mL/min/1.73m2 at 36 weeks (Figure 1). At 72 weeks, UPCR change from baseline was −45% in the all-atacicept group and the placebo switch group showed a −47% UPCR change from baseline at 72 weeks vs +3% at 36 weeks (Figure 2). Open-label atacicept 150 mg was also associated with rapid Gd-IgA1 reduction in the placebo switch group at 48 weeks that was sustained through 72 weeks. Hematuria resolution was observed at 72 weeks in 81% (35/43) of participants in the all-atacicept group and 59% (10/17) in the placebo switch group. Atacicept was generally well tolerated during the open-label extension, with a similar rate of infections compared to the double-blind period and one study drug-related serious adverse event. Conclusion At 72 weeks, treatment with atacicept 150 mg was associated with sustained eGFR stability and deepening UPCR reductions, as well as a reversal of the downward eGFR decline in the placebo switch group. Sustained reductions in hematuria were also observed. The open-label extension showed a favorable safety profile similar to the double-blind period. These results support atacicept 150 mg as a potential disease-modifying treatment for IgAN.

#1185 Cardiovascular, renal and mortality risk by the KDIGO risk classification: the first observational study in Japan

Abstract Background and Aims The prevalence of chronic kidney disease (CKD) has been increasing, affecting 850 million people worldwide and 13 million individuals in Japan. CKD is a risk factor for cardiovascular complications including heart failure, and dialysis. KDIGO risk classification is widely used for the management of people with CKD in Japan; however, risk of clinical outcomes by the KDIGO classification in Japanese population is unclear. The aim of this study is to describe the risk of major adverse cardiovascular event (MACE) and renal outcomes according to the KDIGO classification in Japanese clinical practice. Method This study was a cohort study using data collated from the RWD database which includes electronic medical records and claims data from approximately 200 medical institutions across Japan since 2000. Subjects aged ≥18 years with two or more consecutive results of eGFR <90 mL/min/1.73 m2 at least 90 days apart within a 360-day period were included, and those received renal replacement therapy (RRT; dialysis or renal transplantation) before the index date was excluded. The index date was defined as the date of the second eGFR measurement <90 mL/min/1.73 m2 between January 2004 and December 2020. Patients were categorized into KDIGO classification G2-G5 based on their eGFR values and A1-A3 based on urine protein test (quantitative test and urine dipstick) results and into `no urine protein data` if no urine protein test was available. The primary endpoint was MACE that was defined as a composite of myocardial infarction, stroke, heart failure hospitalization, and in-hospital death. The secondary endpoint was renal outcomes defined as a composite of RRT, eGFR decline >50%, eGFR <15 mL/min/1.73 m2, diagnosis of CKD stage 5, and in-hospital death, and was analyzed in the group excluding patients with eGFR <15 mL/min/1.73 m2 or with diagnosis of stage 5 CKD on or before the index date. The risk of MACE and renal outcomes were evaluated using the cox proportional hazards model with G2A1 as a reference. Sensitivity analyses were performed for the population excluding those without urine protein data and for the population with quantitative urine protein test results. Results This study included 543,606 patients who met the criteria. Mean age was 61.6 ± 15.3 years, and 50.1% was male. Of those, 222,246 (40.9%) had no urine protein data. Tables 1 and 2 show hazard ratio (HR) for MACE and renal outcomes, respectively. HR (95% confidence interval) for MACE was 1.17 (1.12-1.21) in G2A2 and 1.16 (1.12-1.20) in G3aA1, showing significantly increased risk in early stages of CKD, and continued to increase as disease advances to 2.83 (2.54-3.15) in G5A3. HR for renal outcomes was similarly significantly increased in early stages of CKD, and further increased to 19.96 (18.62-21.40) in G4A3. Results of two sensitivity analyses, excluding subjects with no urine protein data (n = 321,360, 59.1% of overall population) shown in Table 3 and 4, and excluding patients with no quantitative data (n = 36,615, 6.7% of overall population) showed similar trends, supporting the robustness of primary findings. Conclusion This study is the first to demonstrate the applicability of the KDIGO risk classification in assessing the risk of cardiovascular events, including heart failure, and renal outcomes in Japan. Risk of events was increased from early stages of CKD (G3aA1 and G2A2), suggesting the importance of early diagnosis and therapeutic intervention through appropriate testing. These findings may contribute to better management of people with CKD.

#2864 IgA dominant post-infectious glomerulonephritis secondary to the infected left ankle joint in a non-diabetic patient, a case report

Abstract Introduction Post-infectious glomerulonephritis (PIGN) is an immune complex glomerulonephritis that commonly affects children and young adults following beta haemolytic Streptococcal throat or skin infections. Kidney biopsy is characterised by Segmental or global endocapillary hypercellularity, and crescents may be present. In immunofluorescence, post-infectious glomerulonephritis typically shows IgG and C3 deposition. A rare type of PIGN is IgA-dominant post-infection glomerulonephritis. It commonly occurs in the setting of active infection. It usually presents in patients > 60 years old with diabetes mellitus, alcohol consumption, and Staphylococcal infections. It can present with RPGN, AKI, and nephrotic syndrome. Hypocomplementemia can be present, and immunofluorescence is characterised by IgA dominance with C3 co-dominance and no IgG. Despite the strong association with Staph aureus, however, it has been reported with other types of infections. The main line of treatment is antibiotic eradication of the infection. Steroids can be used based on the severity of the lesion and the presence of crescents. Its prognosis is worse than that of the traditional PIGN. In this case, we report a case of IgA-dominant post-infectious glomerulonephritis secondary to left ankle osteomyelitis with Staph aureus infection. Case Presentation A 65-year-old lady had open reduction and internal fixation of a left trimalleolar ankle fracture in June 2023 at a district general hospital. Unfortunately, the post-operative course was complicated by wound infection. The wound swab showed Heavy growth of Staphylococcus aureus. This was followed by Acute Kidney Injury (AKI) stage 3; therefore, she was transferred from her hospital to our renal ward. On admission to the ward, her creatinine was 388 μmol/L(baseline creatinine was 73 μmol/L one month before admission), urine dipstick was positive for blood and protein, and urine protein creatinine ratio was 480 mg/mmol. She had only a medical background of bronchial asthma for which she was only on Inhalers (Beta Agonist) as a regular medication. CT scan of the left ankle revealed appearances consistent with osteomyelitis of both the lateral and medial malleoli. This finding was discussed with microbiology and orthopaedic teams, and the patient was started on intravenous antibiotics (Vancomycin followed by doxycycline). A kidney biopsy was done. Mesangial electron-dense deposits were identified. Immunohistochemistry revealed IgA dominant, predominantly mesangial positivity, with associated C3. The picture was consistent with IgA acute glomerulonephritis associated with S. aureus, which is a post-infectious Glomerulonephritis with dominant IgA staining (rather than conventional IgA nephropathy). With proper intravenous hydration and antibiotics, her inflammatory markers started to improve, and her renal chemistry followed the inflammatory markers, and her last creatinine improved to 146 μmol/L, eGFR 31 ml/min and UPCR was 40 mg/mmol. Discussion IgA-dominant post-infectious glomerulonephritis is now a distinct form of PIGN, which usually presents with acute kidney injury, haematuria, and proteinuria and is typically related to Staph aureus infection. In contrast to typical IgA nephropathy, there is no role for steroid or immunosuppression in the treatment of IgA-dominant post-infectious glomerulonephritis, and the treatment is mainly dependent on the treatment of infection.

#123 Impact of atacicept on hematuria in IGA nephropathy: post-hoc analysis of the phase 2b ORIGIN study

Abstract Background and Aims Patients with IgA nephropathy (IgAN) and persistent hematuria during follow up have a greater decline in renal function than those with minimal or no hematuria, while hematuria resolution has been independently associated with less decline in renal function [1, 2]. Atacicept is a fusion protein targeting both BAFF and APRIL in clinical development for IgAN. The Phase 2b ORIGIN study met the primary endpoint with statistically significant urine protein:creatinine ratio (UPCR) reduction at 24 weeks for atacicept vs placebo. At 36 weeks, atacicept 150 mg achieved statistically significant and clinically meaningful UPCR reduction, eGFR stabilization, and robust reduction of galactose-deficient IgA1 vs placebo, with similar safety to placebo. This post-hoc analysis evaluates changes in hematuria during treatment with atacicept vs placebo over 36 weeks. Method The randomized, double-blind, placebo-controlled Phase 2b ORIGIN study included 116 participants with biopsy-proven IgAN, 24h urine protein >0.75 g/day or UPCR >0.75 g/g, and eGFR ≥30 mL/min/1.73 m2 despite optimized renin–angiotensin system blockade. Participants were randomized to atacicept 150, 75, or 25 mg vs placebo (2:2:1:2) self-administered by subcutaneous injection once weekly for up to 36 weeks. Microscopic hematuria was evaluated at weeks 2, 4, 12, 24, and 36 via urine dipstick at a centralized lab, and hematuria levels were graded negative/trace, 1+, 2+, or 3+. Hematuria improvement was defined as a decrease by ≥1 grade, and resolution was defined as a decrease to negative/trace. Results In the intent-to-treat population, 15 of 33 (45%) participants who received atacicept 150 mg and 19 of 34 (56%) who received placebo had hematuria (1+ or greater) at baseline. Of these, 87% (n = 13/15) on atacicept 150 mg had improved hematuria at 36 weeks vs 32% (n = 6/19) on placebo (p = 0.002), with 80% (n = 12/15) on atacicept 150 mg achieving resolution to negative/trace hematuria vs 5% (n = 1/19) on placebo (p < 0.0001) (Figure). The atacicept 150 mg group steadily improved to lower hematuria grades over 36 weeks, with improvement occurring as early as 4 weeks, while the placebo group had no improvement in hematuria over time. The majority of participants without hematuria at baseline maintained negative or trace levels at 36 weeks. Conclusion In a post-hoc analysis, atacicept treatment was associated with hematuria resolution at 36 weeks in a substantially greater percentage of participants as compared with placebo, with improvements seen as early as 4 weeks. These results add to the growing body of evidence supporting atacicept as a potential disease-modifying treatment for IgAN. Atacicept 150 mg is currently being evaluated in a global Phase 3 randomized placebo-controlled trial.

#850 The association between proteinuria and stroke: results from the non-communicable diseases screening programme of Chiang Mai Region, Northern Thailand

Abstract Background and Aims Stroke is a significant global health issue, representing the second leading cause of death and a major contributor to disability. It can be classified into two main types: ischemic stroke, caused by blockage of a brain blood vessel, and haemorrhagic stroke, resulting from blood vessel rupture. Chronic kidney disease (CKD) is another prevalent health concern, affecting approximately 10% of all populations worldwide. CKD impairs kidney function and has been associated with an increased risk of cerebrovascular events, including stroke. Within the Northern Thai population, the prevalence of CKD is higher than the global average, underscoring the importance of investigating the relationship between CKD and stroke in this region. Method All patients for which accurate proteinuria measurement was obtained as part of the NCD screening program in Chiang Mai, Northern Thailand were included in the study. Multilinear cox regression analysis was used to estimate the hazards ratio for the association between proteinuria on stroke. The model was adjusted for other significant confounders of the association including age, sex, CKD, diabetes, hypertension and hypercholesterolaemia Results In a cohort of 3967 patients for which accurate proteinuria measurements were obtained and for whom had complete data for covariates, there was no evidence for an association between proteinuria and stroke. Hazards ratio for stroke in patients with trace proteinuria (adjusted for covariates) was 1.08 (95% CI 0.80-1.45) and positive proteinuria 0.06 (0.78-1.44) compared to a baseline of no proteinuria. Conclusion This study provides important insights into stroke risk factors in the Northern Thai population. The lack of substantial association between proteinuria and stroke suggests that proteinuria may not independently contribute to stroke risk in this cohort. Generalizability, however, is limited due to overrepresentation of diabetes and hypercholesterolaemia in the cohort, which is a strong independent risk factor for stroke. Increasing age is identified as the most critical risk factor for stroke. Understanding these associations can guide targeted interventions and public health strategies for stroke prevention in this population. The study limitations highlight the importance of analysis of a cohort that is more representative of a wider population in terms of chronic disease, such as diabetes and hypercholesterolaemia, and highlights the importance of longer follow up to fully elucidate whether proteinuria has an association with stroke. Furthermore the study raises questions as to whether measurement of proteinuria via urine dipstick analysis may limit conclusions that can be drawn compared to more robust methods such as urine albumin:creatinine or urine protein:creatinine ratios. Finally this study may be underpowered to detect subtle changes of a hazards ratio of less than 1.2, so is at risk of a type 2 statistical error.

#1052 Associations of new-onset proteinuria during hospitalization with all-cause mortality and kidney outcome

Abstract Background and Aims Proteinuria has been routinely screened in hospitalized patients at admission, but the changes in urinary protein during hospitalization is usually neglected. The epidemiology and clinical implication of new-onset proteinuria during hospitalization remains unclear. We aim to examine the associations between new-onset proteinuria during hospitalization with all-cause mortality, cardiovascular mortality, and composite kidney outcomes after discharge. Method We conducted a multicenter cohort of hospitalized adults without proteinuria at admission and with at least one repeated urinary protein test before discharge from the China Renal Data System. New-onset proteinuria was defined as a change in the urine dipstick protein test from negative to 1+ or more during hospitalization. The primary outcome was all-cause mortality after discharge. Secondary outcomes included cardiovascular mortality and composite kidney outcomes of sustained new-onset eGFR<60 ml/min/1.73 m2, >40% decline in eGFR, maintain dialysis, kidney transplant, or end stage renal disease. The associations between new-onset proteinuria and study outcomes were assessed by Cox proportional hazard models. Results Among 219,669 inpatients with mean age of 54 years, new-onset proteinuria occurred in 7.3% of the study population during hospitalization. After a mean follow-up of 4.9 years, patients with new-onset proteinuria during hospitalization was significantly associated with increased risk of all-cause mortality (hazard ratio [HR] 1.16; 95% confidence interval [CI], 1.07-1.25), cardiovascular deaths (HR 1.25; 95% CI, 1.07-1.46), and adverse kidney outcomes (HR 1.51; 95% CI, 1.14-2.01), compared to those without proteinuria. These associations were independent of the occurrence of AKI and remained consistent across subgroups and multiple sensitivity analyses, regardless of the severity and recovery status of new-onset proteinuria. Conclusion The presence of new-onset proteinuria during hospitalization demonstrated significant prognostic value and should be carefully monitored to improve patient care.

Screening of substance use in pregnancy: A Danish cross-sectional study.

There is a paucity of objectively verified data on substance use among Danish pregnant women. We estimated the prevalence of substance use including alcohol and nicotine among the general population of Danish pregnant women. In this anonymous, national, cross-sectional, descriptive study, pregnant women were invited when attending an ultrasound scan between November 2019 and December 2020 at nine Danish hospitals. Women submitted a urine sample and filled out a questionnaire. Urine samples were screened on-site with a qualitative urine dipstick for 15 substances including alcohol, nicotine, opioids, amphetamines, cannabis, and benzodiazepines. All screen-positive urine samples underwent secondary quantitative analyses with gold standard, liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. Results were compared to questionnaire information to analyze the validity of self-reporting and to examine possible cross-reactions. A total of 1903 of 2154 invited pregnant women participated (88.3%). The prevalence of dipstick-positive urine samples was 25.0%. 44.0% of these were confirmed positive, resulting in a total confirmed prevalence of 10.8%. The prevalence of nicotine use was 10.1%-and for all other substances, <0.5%. Nicotine use was more prevalent among younger pregnant women, while other substance use appeared evenly distributed over age groups. Self-reporting of use of nicotine products was high (71.1%), but low for cannabis and alcohol intake (0% and 33.3%, respectively). Prescription medication explained almost all cases of oxycodone, methylphenidate, and benzodiazepine use. Substance use among pregnant women consisted mainly of nicotine. Dipstick screening involved risks of false negatives and false positives. Except for alcohol intake and cannabis use, dipstick analyses did not seem to provide further information than self-reporting. LC-MS/MS analyses remain gold standard, and future role of dipstick screenings should be discussed.

A national audit of facilities, human and material resources for the comprehensive management of diabetes in Ghana-A 2023 update.

The human and material resources as well as the systems for managing diabetes in Africa are inadequate. This study or needs assessment, aimed at updating the human and material resources, identifying the gaps and unmet needs for comprehensive diabetes care in Ghana. We conducted a national audit of 122 facilities in all 16 administrative regions of Ghana. Information obtained covered areas on personnel and multidisciplinary teams, access to medications, access to laboratory services, financing, screening services, management of diabetes complications, and availability/use of diabetes guidelines or protocols. Data was analysed using STATA version 16.1. P-values <0.05 were set as significant. Only 85(69.7%) out of the 122 surveyed facilities had a dedicated centre or service for diabetes care. Twenty-eight (23%) had trained diabetes doctors/specialists; and whilst most centres had ophthalmic nurses and dieticians, majority of them did not have trained diabetes educators (nurses), psychologists, ophthalmologists, podiatrists, and foot/vascular surgeons. Also, 13.9% had monofilaments, none could perform urine dipstick for microalbumin; 5 (4.1%) and just over 50% could perform laboratory microalbumin estimation and glycated haemoglobin, respectively. Access to and supply of human insulins was better than analogue insulin in most centres. Nearly 100% of the institutions surveyed had access to metformin and sulphonylurea with good to excellent supply in most cases, whilst access to Sodium Glucose Transporter-2 inhibitors and Glucagon-like peptide-1 analogues were low, and moderate for Dipeptidyl peptidase-4 inhibitors and thiazolidinediones. Majority of the health facilities (95.1%) offered NHIS as payment mechanism for clients, whilst 68.0% and 30.3% of the patients paid for services using out-of-pocket and private insurance respectively. Fifteen facilities (12.3%) had Diabetes Support Groups in their locality and catchment areas. An urgent multisectoral collaboration, including prioritisation of resources at the facility level, to promote and achieve acceptable comprehensive diabetes care is required.

Urinary tract infections in young infants with a normal urine dipstick.

To assess missed urinary tract infections (UTI) in febrile infants ≤2 months when adhering to recent guidelines suggesting not to send a urine culture with a negative dipstick. A retrospective cohort study of 308 infants ≤2 months with a positive urine culture admitted in 2013-2023, divided into subgroups without exposure to urine dipstick results: 'urosepsis' (UTI with bacteraemia), 'UTI' (positive urine culture, elevated inflammatory markers, no other cause of fever) and 'bacteriuria' (positive urine culture, not meeting the above-mentioned criteria). After retrieving the dipstick results, the 'missed UTI' group (UTI+ negative dipstick) was described. A negative dipstick was found in 2/20 (10%), 32/127 (25%) and 126/161 (78%) of infants with 'urosepsis', 'UTI' and 'bacteriuria', respectively. In the 'missed UTI' group (n = 34), there were more non-Escherichia coli UTI (68% vs. 9% with positive dipstick, p < 0.001), and lower inflammatory markers (leukocytes 15.5 vs. 17.2 k/μL, p = 0.007, C-reactive protein 21 vs. 58 mg/L, p < 0.001). Three infants had high-grade vesicoureteral reflux (VUR) and renal scarring. There is a non-negligible rate of infants ≤2 months with UTI and without pyuria, including those with urosepsis, VUR and renal scarring. We suggest obtaining a urine culture regardless of dipstick results.

Clinical laboratory techniques for detecting drugs of abuse: Feasibility in developing nations

Drugs of abuse are prescription, over-the-counter, or other forms of drugs that are often used for purposes other than those for which they are meant to be used, or in excessive amounts. The abuse of illicit drugs (for example cocaine, heroin, and codeine) poses a serious threat to public health, not to mention a great challenge to the health care system. It is important to review the techniques used in detecting these drugs of abuse to stay ahead of this growing global drug problem. This review aims to give an overview of known clinical laboratory techniques used in detecting some common drugs of abuse that could serve as an integral part of determining the presence of these drugs in bodily fluids and samples. Relevant literature was reviewed in various search engines (Google Scholar, PubMed, ScienceDirect, Bing). Findings showed that some of the current clinical laboratory techniques for detecting and quantifying drugs of abuse include Microcrystalline tests, thin-layer chromatography, colourimetric tests, immunoassays, urine dipstick tests, and ultraviolet spectroscopy. Apart from these known techniques, new and emerging techniques are being validated to serve as additions to these already existing techniques and be used in clinical settings. In conclusion, the burden of drug abuse is on the rise and becoming a public health concern. There should be an ever-increasing interest in developing new analytical methodologies not only to detect but also to quantify drugs of abuse which may be applied in a plethora of areas including clinical settings.Some of the outlined techniques are highly priced and for cost ineffectiveness, they may be difficult to afford and sustain in resource-restraint settings like developing nations. Hence, grants and laboratory infrastructural support may be needed from international donor agencies.

Comparative Retrospective Assessment of the Effectiveness and Risk Factors of Fluoroquinolones, Cephalosporines, and Selective Antibiotic Prophylaxis for Transrectal Prostate Biopsy

Introduction: Despite increasing resistance of enterobacteria against fluoroquinolones (FLU), they are still widely used during transrectal prostate biopsy (TRPB). This study was designed to analyse infectious complications and risk factors between FLU, cephalosporines (CEPH) and selective other antibiotics (O-AB) used during TRPB. Methods: 664 patients were included retrospectively (152 FLU, 452 CEPH and 60 O-AB). Infectious complications were defined as fever >38.0°C, the in-house definition of complicated urinary tract infection (cUTI) (if all applied: fever >38.0°C, leucocytosis >11.000/µL and positive urine dipstick) or postinterventional bacteriuria. Hospitalisation rate, duration and comorbidities were also assessed. χ2 and Fisher’s exact test were used for group comparison. Multivariate regression analysis assessed the association of comorbidities with infectious complications. Results: FLU and CEPH were indifferent regarding infectious complications, however in the O-AB group significantly more common compared to FLU and CEPH (11.6, 13.3, 25%, p < 0.05). Duration of hospital stay in CEPH was significantly shorter compared to FLU and O-AB (4.1 vs. 6.3 vs. 8.2 days, p < 0.05). Arterial hypertension showed increased association with fever (OR 6.002 (1.178; 30.597) p = 0.031) and cUTI (OR 6.006 (1.207; 29.891) p = 0.029). Conclusion: Infectious complications were low and indifferent between FLU and CEPH but significantly more frequent in O-AB. Arterial hypertension was significantly associated with postinterventional fever and cUTI.

Efficacy of praziquantel drug against Schistosoma haematobium and performance of urine reagent strips among pre-and-school aged children during the high transmission season in North-Western Tanzania

The World Health Organization calls for schistosomiasis endemic countries to regularly monitor the efficacy of Praziquantel (PZQ) drug, the only antischistosomal drug used for four decades in Tanzania. In response to that call, the current study investigated the efficacy of single dose of PZQ against Schistosoma haematobium during the high transmission season and further assessed, the sensitivity and specificity of urine reagent strips before and after treatment. The study recruited a total of 2,498 -children aged (4 -17 years old) who provided a single urine sample that was visually examined for macro-haematuria, then using urine dipstick and urine filtration technique for microhaematuria and the presence of S. haematobium eggs. The baseline prevalence of S. haematobium eggs positive based on urine filtration test was 29.2 % (95 %CI:27.5–31.0) and that of microhaematuria was 43.1 % (95 %CI:41.1–45.0). Of the infected participants, 40.9 % (95 %CI:37.4–44.6) had a heavy intensity of infection and the geometrical mean intensity (GMI) of infection was 33.7 eggs/10mls of urine. A single dose of PZQ reduced the prevalence of infection to 16.2 %, the GMI of infection to 18.8eggs/10mls of urine and that of microhaematuria to 27.9 %. Cure rate and egg reduction rates (ERR) were 83.8 % and 44.3 % respectively. At baseline, the sensitivity and specificity of the urine reagent strips were 59.7 % and 93.8 %, whereas at post-treatment they were 16.7 % and 93.6 %. When PZQ drug is administered during the high transmission season, its efficacy in term of ERR is poor. The urine reagent strips had low sensitivity but high specificity at pre-and-post PZQ treatment.

Accuracy of urine dipstick tests for assessment of glucosuria

Accuracy of urine dipstick tests for assessment of glucosuria

Method Validation Study of Dipstick Urinalysis as a Screening Tool for Sodium Nitrite Toxicity.

The incidence of suicide by intentional nitrite ingestion has increased since 2017. Limited options exist for commercial laboratory analysis for nitrite/nitrate. This study investigates the use of urine dipsticks for screening at autopsy for potential toxicity with sodium nitrite and, less commonly, alkyl nitrite. Archived samples of blood, urine, vitreous fluid, and gastric contents from 4 sodium nitrite/nitrate cases, 3 alkyl nitrite cases, and 4 control cases were tested using dipsticks. A rapid, strong positive result for nitrite was in the vitreous fluid of all 4-sodium nitrite/nitrate cases, along with 2 positive urine and 1 positive gastric. The 2 alkyl nitrite inhalation toxicity cases had no positive results. One alkyl nitrite ingestion case had a positive urine. The 4 controls had negative urine: equivocal results in 2 vitreous, and 1 positive gastric. Urine dipsticks are a useful adjunct to laboratory testing for nitrite toxicity and provide a rapid, cost-effective tableside result that may guide the need for further testing. Vitreous fluid and urine appear to be the most reliable specimens, although testing of gastric liquid may be useful to corroborate oral ingestion. Dipsticks may not be a reliable adjunct for testing for alkyl nitrite toxicity via inhalation route, likely due to the much lower nitrite concentration compared to nitrite ingestion cases.

Urine tenofovir testing for real-time PrEP adherence feedback: a qualitative study involving transgender women in Uganda.

Adherence counselling with point-of-care (POC) drug-level feedback using a novel tenofovir assay may support pre-exposure prophylaxis (PrEP) adherence; however, perceptions of urine testing and its impact on adherence are not well studied. We qualitatively examined how POC tenofovir testing was experienced by transgender women (TGW) in Uganda. Within a cluster randomized trial of peer-delivered HIV self-testing, self-sampling for sexually transmitted infections and PrEP among HIV-negative TGW showing overall low PrEP prevention-effective adherence (NCT04328025), we conducted a nested qualitative sub-study of the urine POC assay among a random sample of 30 TGW (August 2021-February 2022). TGW interviews explored: (1) experiences with POC urine tenofovir testing and (2) perceptions of PrEP adherence counselling with drug-level feedback. We used an inductive content analytic approach for analysis. Median age was 21 years (interquartile range 20-24), and 70% engaged in sex work. Four content categories describe how TGW experienced POC urine tenofovir testing: (1) Urine tenofovir testing was initially met with scepticism: Testing urine to detect PrEP initially induced anxiety, with some perceptions of being intrusive and unwarranted. With counselling, however, participants found POC testing acceptable and beneficial. (2) Alignment of urine test results and adherence behaviours: Drug-level feedback aligned with what TGW knew about their adherence. Concurrence between pill taking and tenofovir detection in urine reinforced confidence in test accuracy. (3) Interpretation of urine tenofovir results: TGW familiar with the interpretation of oral-fluid HIV self-tests knew that two lines on the test device signified positivity (presence of HIV). However, two lines on the urine test strip indicated a positive result for non-adherence (absence of tenofovir), causing confusion. Research nurses explained the difference in test interpretation to participants' satisfaction. (4) White coat dosing: Some TGW deliberately chose not to attend scheduled clinic appointments to avoid detecting their PrEP non-adherence during urine testing. They restarted PrEP before returning to clinic, a behaviour called "white coat dosing." Incorporating POC urine testing into routine PrEP adherence counselling was acceptable and potentially beneficial for TGW but required attention to context. Additional research is needed to identify effective strategies for optimizing adherence monitoring and counselling for this population.