Using a simulation model to assess risk of false negative point-of-care urinary human chorionic gonadotropin device results due to high-dose hook interference.

Abstract:

BACKGROUND:It is unclear if the point-of-care (POC) Clinitest hCG device is subject to high-dose hook interference from physiological concentrations of intact human chorionic gonadotropin (hCG), β-core fragment of hCG (hCGβcf), and hCG free β-subunit (hCGβ) found in urine during pregnancy. We used a simulation model to address this question and related our findings to our institution's pregnant population in order to assess risk for potential false-negative hCG results. METHODS:The expected distribution of days relative to ovulation during routine POC hCG testing was estimated from 182 patients. Clinitest-Clinitek Status hCG device susceptibility to high-dose hook interference from hCG variants and potential risk of false-negative results as it relates to this population were evaluated by testing increasing concentrations of hCG, hCGβcf, hCGβ as well as urine simulating physiological hCG, hCGβcf and hCGβ concentrations expected during early pregnancy (≤44 days post-ovulation). RESULTS:The Clinitest-Clinitek Status hCG device exhibited high-dose hook interference from hCGβcf alone, but not from hCG, hCGβ, or simulated physiological urinary concentrations of combined hCG, hCGβcf and hCGβ expected during early pregnancy. The majority of our patient population had urinary hCG testing conducted during early pregnancy. CONCLUSION:The Clinitest-Clinitek Status hCG device is unlikely to exhibit false-negative urinary hCG results due to high-dose hook interference for women in early healthy pregnancy, although additional studies are necessary to determine potential risk in other patient populations. Visual interpretation of POC urinary hCG device results is an important failure mode to consider in risk analyses for erroneous urinary hCG device results.

journal_name

Clin Biochem

journal_title

Clinical biochemistry

authors

Milhorn D,Korpi-Steiner N

doi

10.1016/j.clinbiochem.2014.11.004

subject

Has Abstract

pub_date

2015-02-01 00:00:00

pages

99-104

issue

3

eissn

0009-9120

issn

1873-2933

pii

S0009-9120(14)00746-2

journal_volume

48

pub_type

杂志文章
  • Should functional sensitivity of a new thyroid stimulating hormone immunoassay be monitored routinely? The ADVIA Centaur TSH3-UL assay experience.

    abstract:OBJECTIVES:We emphasize the importance of routine follow-up of subnormal TSH concentrations with QC materials. DESIGN AND METHODS:The functional sensitivity (FS) of the ADVIA Centaur system TSH assay was assessed. We report the values yielded for QC materials in two clinical laboratories. RESULTS:The FS was <0.02 mIU...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2012.04.017

    authors: Reix N,Massart C,Gasser F,Heurtault B,Agin A

    更新日期:2012-10-01 00:00:00

  • Argininosuccinate synthetase gene is silenced by CpG methylation in children with phenylketonuria.

    abstract:OBJECTIVES:The concentration of tyrosine and the ratio of branch-amino acid to the aromatic amino acid in phenylketonuria (PKU) patients are much lower than that of normal people, which reveal that PKU patients have amino acid metabolism disorder. The aim of the present study was to investigate the arginine level in bl...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2013.10.028

    authors: Li L,Jin C,Ye L,Shao G,Wang L,Lin M

    更新日期:2013-12-01 00:00:00

  • Determination of renal clearances of amylase/creatinine with chromogenic and enzymatic methods.

    abstract::Urinary amylase was estimated by chromogenic (amylochrome Roche) as well as enzymatic methods (SKI and Beckman: substrate starch and substrate maltotetraose respectively). Random and timed urines (24 hour collections) were analysed. Clearances of amylase gave different results dependent upon the amylase-test used and ...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/s0009-9120(79)80125-3

    authors: Hohenwallner W,Wimmer E,Sommer R

    更新日期:1979-12-01 00:00:00

  • Analytical interference of 4-hydroxy-3-methoxymethamphetamine with the measurement of plasma free normetanephrine by ultra-high pressure liquid chromatography-tandem mass spectrometry.

    abstract:OBJECTIVES:The diagnosis of pheochromocytoma relies on the measurement of plasma free metanephrines assay whose reliability has been considerably improved by ultra-high pressure liquid chromatography tandem mass spectrometry (UHPLC-MS/MS). Here we report an analytical interference occurring between 4-hydroxy-3-methoxym...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2014.04.003

    authors: Dunand M,Donzelli M,Rickli A,Hysek CM,Liechti ME,Grouzmann E

    更新日期:2014-08-01 00:00:00

  • Regulation of cytoplasmic pH in phagocytic cell function and dysfunction.

    abstract::To ensure effective antimicrobial or tumouricidal function, phagocytic cells must maintain their cytoplasmic pH (pHi) at a level conductive to optimal intracellular enzyme activity. The mechanisms by which neutrophils and macrophages regulate their cytoplasmic pH include bicarbonate-independent ion transport systems, ...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章,评审

    doi:10.1016/0009-9120(91)80014-t

    authors: Grinstein S,Swallow CJ,Rotstein OD

    更新日期:1991-06-01 00:00:00

  • Nonalcoholic steatohepatitis: recent advances from experimental models to clinical management.

    abstract::A condition defined as nonalcoholic fatty liver disease (NAFLD) is frequently found in humans. Deemed as a benign condition until recently, more emphasis is now put on the potential harmful evolution of the inflammatory form, that is, nonalcoholic steatohepatitis (NASH), toward end-stage liver disease. This review hig...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章,评审

    doi:10.1016/j.clinbiochem.2004.10.014

    authors: Portincasa P,Grattagliano I,Palmieri VO,Palasciano G

    更新日期:2005-03-01 00:00:00

  • Modifications to commercial oxalate oxidase based determination of urinary oxalate: a method suitable for routine clinical analysis.

    abstract::A commercially available assay (Sigma) for urinary oxalates based on the oxalate oxidase/peroxidase catalyzed reaction produced, in our hands, recoveries of added oxalate that varied from patient to patient. A modification of the assay is reported that involves the chromatographic separation of interfering substances,...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/0009-9120(90)80032-e

    authors: Mazzuchin A,Michelutti L,Falter H

    更新日期:1990-04-01 00:00:00

  • The production of creatine kinase isozyme BB in sera of a patient with prostatic carcinoma and in tumor homogenates.

    abstract::1. A CK(BB) fraction was observed in sera of a patient with prostatic carcinoma. The fraction accounted for 59% of the total enzyme activity. A metastatic tumor of a prostatic carcinoma was observed to contain solely the CK(BB) isozyme. An embryonal testicular carcinoma was observed to have a higher percentage of the ...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/s0009-9120(78)90641-0

    authors: Hoag G,Amies DR,Colquhoun BD

    更新日期:1978-04-01 00:00:00

  • A novel mutation on the transferrin gene abolishes one N-glycosylation site and alters the pattern of transferrin isoforms, mimicking that observed after excessive alcohol consumption.

    abstract:OBJECTIVES:In the process of obtaining a driver's license, a healthy 28year old man presented increased levels of disialo-transferrin (TF) (approx. 20%, ref. value<2) by HPLC analysis of TF isoforms (%CDT), while other markers of excessive alcohol consumption (PEth, MCV and γ-GT) were in the normal range. The objective...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2015.12.001

    authors: Grahn A,Bengtson P,Eklund E,Asin-Cayuela J

    更新日期:2016-04-01 00:00:00

  • Performance of flow cytometry to screen urine for bacteria and white blood cells prior to urine culture.

    abstract:BACKGROUND:The gold standard test for the diagnosis of urinary tract infection is bacterial culture. However, urine cultures are labor intensive and costly. Furthermore, since results take 1-2 days many patients are treated presumptively prior to culture results being known. METHODS:We evaluated the Sysmex UF-1000i fo...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2013.03.005

    authors: Giesen CD,Greeno AM,Thompson KA,Patel R,Jenkins SM,Lieske JC

    更新日期:2013-06-01 00:00:00

  • Association of glutathione-S-transferase gene polymorphism and lipoprotein subclasses in hemodialysis patients.

    abstract:OBJECTIVES:End-stage renal disease (ESRD) is characterized by profound dyslipidemia and enhanced oxidative stress. The patients also show evidence of exhausted and/or deficient anti-oxidative defense enzymes, one of them being glutathione-S-transferase (GST). This study investigates relationship between GST gene polymo...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2013.11.011

    authors: Vekic J,Zeljkovic A,Jelic-Ivanovic Z,Damjanovic T,Suvakov S,Matic M,Savic-Radojevic A,Simic T,Spasojevic-Kalimanovska V,Gojkovic T,Spasic S,Dimkovic N

    更新日期:2014-04-01 00:00:00

  • Glutathione S-transferases activity in patients with colorectal cancer.

    abstract:OBJECTIVES:The glutathione S-transferases (GSTs) play a critical role in protecting the colorectal mucosa. We investigated the efficacy of using the GSTs activity of plasma as a biomarker of risk for colorectal cancer. METHODS:GSTs activity was measured in the plasma of control individuals (n=39) and in the plasma, tu...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2005.04.004

    authors: Nomani H,Ghobadloo SM,Yaghmaei B,Rezvanie NA,Yaghmaei K

    更新日期:2005-07-01 00:00:00

  • The susceptibility of lipoprotein(a) to copper oxidation is correlated with the susceptibility of autologous low density lipoprotein to oxidation.

    abstract:OBJECTIVES:Lipoprotein(a) [Lp(a)] can be oxidized by copper in vitro in a way comparable to low-density lipoprotein (LDL). We sought to determine whether the susceptibility of Lp(a) to oxidation is correlated with the susceptibility of autologous heterogeneous LDL, with apolipoprotein(a) [apo(a)] molecular size, or wit...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/s0009-9120(02)00438-1

    authors: Nakajima K,Yamashita T,Kusuhara M,Yonemura A,Ito T,Higashi K,Ayaori M,Ohmori R,Nakamura H,Ohsuzu F

    更新日期:2003-03-01 00:00:00

  • Stratus CS cardiac troponin I method: performance characteristics including imprecision at low concentrations.

    abstract:OBJECTIVES:Define performance characteristics of the Stratus CS cardiac troponin I (cTnI) assay in routine practice. METHODS:Imprecision at low cTnI values was assessed according to NCCLS EP5-A. Linearity was assessed by regression analysis; the reference interval was determined in 345 healthy individuals. Minimum det...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2004.03.009

    authors: Christenson RH,Cervelli DR,Bauer RS,Gordon M

    更新日期:2004-08-01 00:00:00

  • Efficacy of simultaneous determination of bone alkaline phosphatase mass concentration in serum and urinary excretion of pyridinium cross-links for detection of bone metastases.

    abstract:OBJECTIVES:To examine the diagnostic validity of bone alkaline phosphatase (BAP) in serum (a marker of bone formation) and of urinary excretion of pyridinium cross-links (PYR) (a marker of bone resorption) for detection of bone metastases. DESIGN AND METHODS:Two heterogeneous immunoassays were employed for determinati...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/0009-9120(95)96621-a

    authors: Withold W,Georgescu G,Khakzad H,Vosberg H,Mueller-Gaertner HW,Reinauer H

    更新日期:1995-10-01 00:00:00

  • Correlation of endothelin 1 plasma levels with plasma antioxidant capacity in elderly patients treated for hypertension.

    abstract:UNLABELLED:Experimental studies confirmed that reactive oxygen species increase endothelin-1 (ET-1) synthesis, and modulate ET-1 signaling pathway resulting in vasoconstriction and vascular remodeling. The aim of this study was to evaluate the relationship between plasma ET-1 concentration and antioxidant status in pat...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2008.11.002

    authors: Skalska AB,Pietrzycka A,Stepniewski M

    更新日期:2009-03-01 00:00:00

  • Serum retinol binding protein 4 in patients with familial partial lipodystrophy.

    abstract:OBJECTIVE:To determine Retinol Binding Protein 4 (RBP4) levels in patients with Familial Partial Lipodystrophy (FPLD). METHODS:Ten patients with FPLD and a control group (9 patients) were selected to participate in the study. RESULTS:RBP4-log levels were lower in patients with FPLD in comparison to control group (1.5...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2009.03.006

    authors: Godoy-Matos AF,Moreira RO,MacDowell R,Bendet I,Mory PB,Moises RS

    更新日期:2009-07-01 00:00:00

  • Association of the MS4A2 gene promoter C-109T or the 7th exon E237G polymorphisms with asthma risk: a meta-analysis.

    abstract:BACKGROUND AND OBJECTIVE:A large number of studies have examined the association between the Membrane-spanning 4 domains, superfamily A, number 2 (MS4A2) gene C-109T (rs1441586) or E237G (rs569108) variants and asthma risk. However, the results are inconsistent and inconclusive. To derive a more precise estimation, a m...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章,meta分析

    doi:10.1016/j.clinbiochem.2014.01.022

    authors: Yang HJ,Zheng L,Zhang XF,Yang M,Huang X

    更新日期:2014-05-01 00:00:00

  • Evaluation of SARS-CoV-2 prototype serologic test in hospitalized patients.

    abstract:OBJECTIVES:Humoral immune response to SARS-CoV-2 infection has been reported in several patient cohorts with results that vary by method and population studied due to the lack of reliable commercial assays available as the pandemic initially spread. We sought to clinically assess commercial prototype SARS-CoV-2 IgG and...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2020.08.008

    authors: Wheeler SE,Shurin GV,Keetch C,Mitchell G,Kattel G,McBreen J,Shurin MR

    更新日期:2020-12-01 00:00:00

  • The clinical relevance of imatinib plasma trough concentrations in chronic myeloid leukemia. A Belgian study.

    abstract::This retrospective multicenter study in patients with chronic myeloid leukemia in chronic phase was undertaken to confirm the clinical relevance of imatinib plasma concentrations monitoring in daily practice. Forty-one patients, with 47 imatinib plasma measurements, were analyzed during treatment with imatinib given a...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章,多中心研究

    doi:10.1016/j.clinbiochem.2016.12.006

    authors: Van Obbergh F,Knoops L,Devos T,Beguin Y,Graux C,Benghiat F,Kargar-Samani K,Bauwens D,Efira A,Dubois C,Springael C,Montfort L,Connerotte T,Capron A,Delannoy A,Wallemacq P

    更新日期:2017-05-01 00:00:00

  • Activity and protein level of CuZnSOD and MnSOD in benign and malignant liver tumors.

    abstract:OBJECTIVES:Superoxide dismutase (SOD) is a key antioxidant enzyme, responsible for scavenging of superoxide anion - a precursor of all reactive oxygen species (ROS). ROS are implicated in many pathologies, particularly in tumor disease. The aim of our work was to evaluate SOD isoforms' activity and protein level change...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2007.09.014

    authors: Skrzycki M,Scibior D,Podsiad M,Czeczot H

    更新日期:2008-01-01 00:00:00

  • Cellular and secreted lipoprotein lipase revisited.

    abstract::Lipoprotein lipase (LPL) of adipose cells is present only in membrane compartments, mainly in the Golgi apparatus. LPL is a typical secretory protein which appears to be active as a homodimer. The process of LPL synthesis and maturation requires multiple steps. LPL is synthesized in the endoplasmic reticulum as an ina...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章,评审

    doi:10.1016/0009-9120(90)90034-r

    authors: Ailhaud G

    更新日期:1990-10-01 00:00:00

  • Comparison of plasma ammonia results from seven different automated platforms in use throughout Central Australia.

    abstract:INTRODUCTION:The clinical catchment area for the Metabolic service at the Women's and Children's Hospital in Adelaide, South Australia, covers nearly 2.5millionkm2. Care of children with metabolic disorders in these remote areas is assisted from Adelaide, and at times, using plasma ammonia results from laboratories up ...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2016.11.025

    authors: Markus C,Metz M

    更新日期:2017-04-01 00:00:00

  • Batch to batch imprecision in the affinity chromatography assay of glycated hemoglobin.

    abstract::An affinity chromatographic method (AC) was compared with ion exchange chromatography (IEC) for determination of glycated hemoglobin (gHb). In vitro, increasing glucose concentration produced no change on AC-determined gHb. gHb measurement by AC was highly correlated with mean blood glucose (r = 0.96). Mean values of ...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/s0009-9120(86)80010-8

    authors: Wettre S,von Schenck H

    更新日期:1986-12-01 00:00:00

  • Immunoassays with time-resolved fluorescence spectroscopy: principles and applications.

    abstract::This review deals with the application of time-resolved fluorescence spectroscopy in the field of immunoassay. The advantages of time-resolved fluorescence over conventional fluorometry are discussed and it is explained why the fluorescent lanthanide chelates, and especially the Eu3+ chelates, are the labels of choice...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章,评审

    doi:10.1016/0009-9120(88)90001-x

    authors: Diamandis EP

    更新日期:1988-06-01 00:00:00

  • Apolipoprotein B-100 kinetics and static plasma indices of triglyceride-rich lipoprotein metabolism in overweight men.

    abstract:OBJECTIVE:We examined the association of plasma apolipoprotein (apoB) B-48, remnant-like particle (RLP)-cholesterol and non-HDL cholesterol concentrations with apoB-100 kinetics in overweight-obese men. METHODS AND RESULTS:Very-low density lipoprotein (VLDL), intermediate-density lipoprotein (IDL) and low-density lipo...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2005.05.009

    authors: Chan DC,Watts GF,Ng TW,Uchida Y,Sakai N,Yamashita S,Barrett PH

    更新日期:2005-09-01 00:00:00

  • Quantification of pepsinogen C and prostaglandin D synthase in breast cyst fluid and their potential utility for cyst type classification.

    abstract:OBJECTIVE:To quantify pepsinogen C (PEPC) and prostaglandin D synthase (PGDS) in breast cyst fluid and examine if these two parameters can be used for breast cyst type classification. DESIGN AND METHODS:We quantified PEPC and PGDS in 92 and 50 breast cyst fluids, respectively, using previously established immunofluoro...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/s0009-9120(98)00079-4

    authors: Borchert GH,Melegos DN,Yu H,Giai M,Roagna R,Ponzone R,Sgro L,Diamandis EP

    更新日期:1999-02-01 00:00:00

  • Evaluation of plasma ammonia levels in patients with acute liver failure and chronic liver disease and its correlation with the severity of hepatic encephalopathy and clinical features of raised intracranial tension.

    abstract:OBJECTIVES:The present study was designed to (a) evaluate and compare plasma ammonia levels (PAL) in patients with acute liver failure (ALF) and chronic liver disease (CLD) with or without hepatic encephalopathy (HE); (b) correlate the severity of HE with PAL; and (c) correlate PAL with clinical features of raised intr...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2005.04.013

    authors: Kundra A,Jain A,Banga A,Bajaj G,Kar P

    更新日期:2005-08-01 00:00:00

  • Association of serum bilirubin levels with albuminuria in patients with essential hypertension.

    abstract:OBJECTIVES:This study was undertaken to evaluate the relationship between serum bilirubin concentrations and the degree of urinary albumin excretion in hypertensive patients. DESIGN AND METHODS:A total of 120 hypertensive subjects were enrolled, in which 80 (67%) with normoalbuminuria (albumin excretion rate [AER] of ...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2011.03.137

    authors: Huang SS,Huang PH,Chiang KH,Chen JW,Lin SJ

    更新日期:2011-07-01 00:00:00

  • Cardiac troponin T concentrations and patient-specific risk of myocardial infarction using the novel PALfx parameter.

    abstract:BACKGROUND:Myocardial infarction (MI) is more likely if the heart damage biomarker cardiac troponin T (cTnT) is elevated in a blood sample from a patient with chest pain. There is no conventional method to estimate the risk of MI at a specific cTnT concentration. The purpose of this study was to evaluate the performanc...

    journal_title:Clinical biochemistry

    pub_type: 杂志文章

    doi:10.1016/j.clinbiochem.2019.02.003

    authors: Ognissanti D,Bjurman C,Holzmann MJ,Theodorsson E,Petzold M,Cvijovic M,Hammarsten O

    更新日期:2019-04-01 00:00:00