Clinitek status analyzer

Manufactured by Siemens

Sourced in United States

The Clinitek Status Analyzer is a compact, automated urine chemistry analyzer designed to perform a variety of in-vitro diagnostic tests. The device is capable of analyzing urine samples and providing quantitative or semi-quantitative results for various analytes such as glucose, protein, and bilirubin. The Clinitek Status Analyzer is intended for professional use in clinical laboratory or point-of-care settings.

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Lab products found in correlation

Multistix 10 sg, by Siemens (7 mentions) Facscount, by BD (2 mentions) Cobas ampliprep taqman v2.0 hiv 1 viral load assay, by Roche (2 mentions) Facscalibur, by BD (2 mentions) Dimension xpand plus hm clinical analyzer, by Siemens (1 mentions) Cobas integra 400 plus, by Roche (1 mentions) Integra 400 plus, by Roche (1 mentions) Cobas c501, by Roche (1 mentions) Multistix 10sg urinalysis reagent strips, by Siemens (1 mentions) Xn 2000, by Sysmex (1 mentions) Integra 400, by Roche (1 mentions) Cobas integra 400, by Roche (1 mentions) Uv 1800 spectrophotometer, by Shimadzu (1 mentions) Free style precision, by Abbott (1 mentions)

17 protocols using clinitek status analyzer

Urine Dipstick Analysis for Kidney Function

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Bayer Multistix 10 SG were read by a Siemens CLINITEK Status+ Analyzer.
Urine dipstick urine-specific gravity (USG) (intervals of 5 from 1005 to 1030), and haematuria (0, +, ++, +++), leukocyturia (0, +, ++) and proteinuria (0, trace, +, ++, +++) were entered as linear independent variables in separate regression models of ΔeGFR_{cross-harvest} at each of the nine sampling occasions during harvest and time of sampling (preshift and postshift). For each model, the proportion of the variance in ΔeGFR_{cross-harvest} explained by the dipstick parameter was calculated.

Hansson E., Wesseling C., Wegman D., Ekström U., Chavarria D., Glaser J, & Jakobsson K. (2022). Point-of-care biomarkers for prediction of kidney function trajectory among sugarcane cutters: a comparative test accuracy study. BMJ Open, 12(11), e060364.

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Urine Collection and Analysis for Diagnosis

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Urine was collected by midstream collection (to eliminate potential contamination of urine by bacteria in the urethra) or urinary bladder catheterization (UBC, less prone for contamination than a midstream urine) at the outpatient clinic. The minimum sample volume was 6 mL. Urinalysis was performed using the dipstick method (Multistix^® 10 SG on a Clinitek Status+^® analyzer, Siemens Healthcare, The Hague, The Netherlands). Abnormal urinalysis was defined as a positive result for nitrite and leukocytes [17 (link)]. If an abnormal urinalysis was found the remaining urine was divided into three separate test tubes, one for urine culture and two for eNose analysis. All samples for eNose diagnostics were marked, directly frozen, and stored at −20 °C until further handling.

Visser E.H., Berkhout D.J., Singh J., Vermeulen A., Ashtiani N., de Boer N.K., van Wijk J.A., de Meij T.G, & Bökenkamp A. (2020). Smell—Adding a New Dimension to Urinalysis. Biosensors, 10(5), 48.

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Exercise-Induced Urine Analysis

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Urine samples were collected after exercise and with the use of a urinary dipstick (Clinitek Status® analyzer, Siemens Healthcare diagnostics Inc., Tarrytown, New York) tested for the presence of erythrocytes, haemoglobin and/or myoglobin.

Terink R., ten Haaf D., Bongers C.W., Balvers M.G., Witkamp R.F., Mensink M., Eijsvogels T.M., Gunnewiek J.M, & Hopman M.T. (2018). Changes in iron metabolism during prolonged repeated walking exercise in middle-aged men and women. European Journal of Applied Physiology, 118(11), 2349-2357.

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Urine Biomarker Measurement Protocol

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For uNGAL testing, we collected up to 2 mL of urine via urethral catheterization into a centrifuge tube. The urine was refrigerated immediately at 4°C. Within 12 hours of collection, the urine was centrifuged at 1000 revolutions per minute and the supernatant stored at −80.0°C. A minimum of 0.1 mL of urine was required for uNGAL processing. At the end of patient enrollment, we determined uNGAL concentration by enzyme-linked immunosorbent assays in a research laboratory. uNGAL was expressed in ng/mL using a standardized commercial platform for total human NGAL (BioPorto KIT 036). The lab technicians performing uNGAL testing were blinded to all clinical and laboratory data (e.g. UA and culture results).
The UAs and Gram’s stains were performed as per standard hospital laboratory procedure. Standard laboratory UA for nitrite and LE was completed using the automated urine analyzer Iris iChem100 (Beckman Coulter Diagnostics) on uncentrifuged urine. Point of care (POC) dipstick was performed using the Siemens CLINITEK Status^®+ Analyzer. When both standard laboratory UA and POC dipstick were performed for the same patient, we used the standard laboratory UA in our analysis. Gram’s stain was prepared by an automated system using uncentrifuged urine and was read manually.

Lubell T.R., Barasch J.M., Xu K., Ieni M., Cabrera K.I, & Dayan P.S. (2017). Urinary Neutrophil Gelatinase–Associated Lipocalin for the Diagnosis of Urinary Tract Infections. Pediatrics, 140(6), e20171090.

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Urine VDBP Quantification and Analysis

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Urine VDBP was measured using a commercially available ELISA (R&D Systems). Intra- and interassay coefficient of variations were 5.9% and 6.2%, respectively. Data were analyzed raw and normalized to urine creatinine. Urine creatinine measurements were made using a modified Jaffe reaction, and microalbumin (MALB) was measured by immunoturbidimetry, both on a Dimension Xpand plus HM Clinical Analyzer (Siemens). Coefficients of variability for the creatinine measurements were 2.4% (intra) and 4.2% (total), and 2.9% (intra) and 5.9% (inter) for MALB. Urinalysis by dipstick (Multistix 10 SG, Siemens) was performed as part of a routine clinical care and read on a Clinitek+ Status Analyzer (Siemens).

Bennett M.R., Pordal A., Haffner C., Pleasant L., Ma Q, & Devarajan P. (2016). Urinary Vitamin D-Binding Protein as a Biomarker of Steroid-Resistant Nephrotic Syndrome. Biomarker Insights, 11, 1-6.

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Comprehensive Clinical and Laboratory Analyses

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All samples were analysed in the MRC/UVRI Uganda Unit’s CDLS laboratories. The Clinical chemistry analyser, COBAS Integra 400 plus (Roche Diagnostics) was used to measure fasting serum lipids and blood glucose, and renal and liver function test parameters. Full blood counts were measured using the Coulter AcT5 Diff CP Analyser (Beckman Coulter, USA). CD4 cell counts were measured using either the FACSCount or FACSCalibur machine (Becton–Dickinson, USA). Plasma HIV-1 RNA was quantified using the COBAS Ampliprep/Taqman V2.0 HIV-1 viral load assay (Roche Molecular Diagnostics [RMD], NJ, USA) with a lower detection limit of 20 copies/ml. For urine strip testing, we used the Siemens Multistix 10SG and read with Clinitek Status Analyzer (Siemens Healthcare Diagnostics). For ARV drug resistance, PCR and sequencing reactions were conducted and the sequences submitted to the Stanford University HIV Drug Resistance database. The surveillance drug resistance mutations were identified using the 2009 WHO list for surveillance of transmitted drug resistances [36 (link)], using the Stanford calibrated population resistance analysis tool version 5.0 beta [37 (link)]. Sequences with genetic mixtures of wild-type and mutant sequences at amino acid sites that code for SDRMs were considered to be drug-resistant.

Mayanja B.N., Kasamba I., Levin J., Namakoola I., Kazooba P., Were J., Kaleebu P, & Munderi P. (2017). COHORT PROFILE: The Complications of Long-Term Antiretroviral Therapy study in Uganda (CoLTART), a prospective clinical cohort. AIDS Research and Therapy, 14, 26.

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Urine Culture Protocol for UTI Diagnosis

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Electronic medical records were reviewed for pertinent demographic, clinical, and laboratory data, including urine dipstick and urine culture results. Fever was considered present when reported by the patient or caregiver or when a temperature ≥ 38°C was documented in the ED/UC. Dipstick urinalyses were performed either in the ED or UC laboratory using the CLINITEK Status^®+ Analyzer (Siemens, Tarrytown, NY, USA) or in the hospital chemistry laboratory using the iChem^® Velocity™ instrument (Iris Diagnostics, Chatsworth, CA, USA). Urine was plated by clinical microbiology laboratory staff using calibrated loops and cultured on 5% sheep blood and MacConkey agar biplates and incubated at 35˚C in ambient atmosphere. A positive urine culture result consisted of ≥ 50 000 colony forming units (CFU) per mL of a single uropathogen (21 (link),23 (link)). Urine cultures were considered negative if they yielded < 50 000 CFU/mL, mixed bacteria, or likely contaminants such as Lactobacillus species, coagulase-negative staphylococci, or Corynebacterium species (23 (link)).

Watson J.R., Hains D.S., Cohen D.M., Spencer J.D., Kline J.M., Yin H, & Schwaderer A.L. (2016). Evaluation of Novel Urinary Tract Infection Biomarkers in Children. Pediatric research, 79(6), 934-939.

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Delayed Urine NGAL Testing Protocol

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POC UA was performed immediately after urine collection using the Siemens CLINITEK Status+ analyzer in the pediatric ED. Urine was then immediately refrigerated at 4°C. Within 24 h of collection, the urine was transported to a laboratory where the POC uNGAL dipstick was performed; the remainder was centrifuged at 1000 rpm for 15 min; and the supernatant was aliquoted, frozen at −80°C, and batched for later processing for quantitative uNGAL and urine creatinine (UCr). There were no freeze/thaw cycles prior to biomarker analysis. Data support that uNGAL testing can be delayed with samples processed and stored in this manner for up to 5 years without protein degradation.^{28 (link),29 (link)} We measured uNGAL quantitatively by ELISA and semiquantitatively in ng/mL using investigational commercial platforms, BioPorto KIT 036 and BioPorto rapid assay device, respectively (BioPorto). For dipstick, semiquantitative uNGAL testing, a color chart differentiated uNGAL levels at intervals of <25, 25–50, 50–100, 100–150, 150–300, 300–600, and >600 ng/mL. uCr was measured by the Integra 400 Plus automated analyzer (Roche Diagnostics). The laboratory technicians performing uNGAL and uCr testing were blinded to clinical data and culture results.

Lubell T.R., Barasch J.M., King B., Ochs J.B., Fan W., Duong J., Chitre M, & Dayan P.S. (2021). Urinary tract infections in children: Testing a novel, noninvasive, point-of-care diagnostic marker. Academic emergency medicine : official journal of the Society for Academic Emergency Medicine, 29(3), 326-333.

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Histological Analysis of Renal Lesions

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Kidneys from IFN-α administered Pep^+/+ (n = 5) and Pep^−/− (n = 3) mice were fixed in 10% neutral buffer formalin, processed, and embedded in paraffin for sectioning. ∼3-µm sections were de-paraffinized and stained with hematoxylin and eosin or Periodic acid-Schiff (PAS). Renal lesions were scored on arbitrary severity scales from 0 to 3 for each of the features: glomerulopathy, interstitial nephritis, and arteritis. Proteinuria was evaluated in urine collected weekly. Urine protein levels were scored with Multistix 10 SG (Siemens) dipsticks on a Clinitek Status Analyzer (Siemens). Protein levels are scored as 1 (30 mg/dl), 2 (100 mg/dl), or 3 (>300 mg/dl).

Holmes D.A., Suto E., Lee W.P., Ou Q., Gong Q., Smith H.R., Caplazi P, & Chan A.C. (2015). Autoimmunity-associated protein tyrosine phosphatase PEP negatively regulates IFN-α receptor signaling. The Journal of Experimental Medicine, 212(7), 1081-1093.

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Comprehensive Urine Analysis Protocol

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Urine samples were collected during the outpatient biopsy procedure visit or during inpatient hospitalization. We performed urine dipstick analysis using Clinitek Status analyzer (Siemens Healthcare Diagnostics Inc., Tarrytown, NY) which reported specific gravity, pH, protein, ketone, blood, and leukocyte levels on an ordinal scale. We also performed urine sediment microscopy (Laxco LMC4BF, Fisher Scientific) and took representative pictures at 10x and 40× magnification, which were analyzed and reported by a trained nephrologist (DGM) on an ordinal scale including RBCs, RBC casts, dysmorphic RBCs, WBCs, WBC casts, RTE cells, RTE casts, and granular casts. Urine samples were collected at a median (IQR) of 2.1 (−2.2, 4.0) before the biopsy and stored at −80 °C prior to biomarker analysis. After a single controlled thaw, we measured urine albumin and creatinine measurements using Randox RX Daytona machine and the other urine biomarkers using manufacturer-validated panels using the Mesoscale Discovery platform. We normalized urine albumin and other biomarkers to urine creatinine to account for urine concentration differences. The personnel performing urine dipstick, urine sediment microscopy and measuring biomarkers were blinded to the case status. A complete list of all tests evaluated in this study are presented in Table S2.

Tran A.C., Melchinger H., Weinstein J., Shaw M., Kent C., Perazella M.A., Wilson F.P., Parikh C.R, & Moledina D.G. (2022). Urine testing to differentiate glomerular from tubulointerstitial diseases on kidney biopsy. Practical Laboratory Medicine, 30, e00271.

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