Limitations of Accelerated Stability Model Based on the Arrhenius Equation for Shelf Life Estimation of In Vitro Diagnostic Products.

Abstract:

BACKGROUND:An accelerated stability model based on the Arrhenius Equation can be used to estimate stability of diagnostic reagents. Here we review 3 examples in which the model does not accurately predict the stability of diagnostic reagents. METHODS:We prepared several pilot lots of quality controls materials containing fructosamine, BNP, and HbA1c in human whole blood and serum matrices and performed accelerated stability studies at increased temperatures (5 °C to 35 °C) and real-time stability studies at the recommended storage temperature (-10 °C to -20 °C) for several analytes in quality control materials. RESULTS:We observed that the stability predictions obtained from the accelerated stability studies were longer in 2 instances and much shorter in another than those observed from the real-time stability studies. CONCLUSIONS:Due to discrepancies between the stability results from accelerated stability studies and those from the real-time stability studies, we stress the need for caution when reagent manufacturers use the Arrhenius model and recommend that the technical groups and committees assigned to revise CLSI and ISO stability documents highlight the limitations of the accelerated stability model and include more guidance and direction on how and when to use the accelerated stability model.

journal_name

Clin Chem

journal_title

Clinical chemistry

authors

Ebrahim A,DeVore K,Fischer T

doi

10.1093/clinchem/hvaa282

subject

Has Abstract

pub_date

2020-12-04 00:00:00

eissn

0009-9147

issn

1530-8561

pii

6024428

pub_type

杂志文章
  • Minimal disease detection and confirmation in hematologic malignancies: combining cell sorting with clonality profiling.

    abstract:BACKGROUND:In this study we demonstrate the technical application of flow cytometry and cell sorting combined with gene-rearrangement clonality profiling to detect and confirm minimal disease in 2 leukemia and 2 lymphoma cases. METHODS:Specimens with low percentages (0.05%-5%) of abnormal lymphoid populations were ide...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2005.061259

    authors: Zehentner BK,Fritschle W,Stelzer T,Ghirardelli KM,Hunter K,Wentzel C,Bennington R,Hansen CL,Myerson D,Kalnoski M,Wells DA,Loken MR

    更新日期:2006-03-01 00:00:00

  • DNA enzyme immunoassay: general method for detecting products of polymerase chain reaction.

    abstract::We developed a new colorimetric method, DNA enzyme immunoassay (DEIA), for detecting specific hybrids of complementary nucleic acids and applied it to the detection of hepatitis B virus (HBV) DNA amplified from serum samples by means of the polymerase chain reaction (PCR) technique. The method is based on the ability ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Mantero G,Zonaro A,Albertini A,Bertolo P,Primi D

    更新日期:1991-03-01 00:00:00

  • Response-surface-optimized, zinc-enhanced assay for serum alkaline phosphatase.

    abstract::An optimized assay for alkaline phosphatase (EC 3.1.3.1) is reported. A discrete analyzer, the DuPont Automatic Clinical Analyzer (aca), was used for this study. The assay is based on results of response-surface experimental co-optimization techniques, and response is enhanced over the present aca assay. A key feature...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Thompson JC,Hodges CT,Dobler GL,Williamson JA Jr

    更新日期:1981-07-01 00:00:00

  • Homogeneous amplification and mutation scanning of the p53 gene using fluorescent melting curves.

    abstract:BACKGROUND:In malignancy, gene mutations frequently occur in tumor suppressor genes such as p53 and are sporadically located. We describe a homogeneous method for amplification and mutation scanning, and apply the method to the p53 gene. METHODS:Using a series of overlapping fluorescein-labeled oligonucleotides comple...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Millward H,Samowitz W,Wittwer CT,Bernard PS

    更新日期:2002-08-01 00:00:00

  • Expression of prostate-specific antigen and prostate-specific membrane antigen transcripts in blood cells: implications for the detection of hematogenous prostate cells and standardization.

    abstract::Circulating prostate cells can be detected in cancer patients by using reverse transcriptase-PCR (RT-PCR) assay for prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSM) mRNA. A quality-control study involving a conventional RT-PCR assay was performed and, surprisingly, detected both transcripts...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Gala JL,Heusterspreute M,Loric S,Hanon F,Tombal B,Van Cangh P,De Nayer P,Philippe M

    更新日期:1998-03-01 00:00:00

  • IgG heavy-chain subclass typing of myeloma paraproteins by isoelectric focusing immunoblot analysis.

    abstract::The objective of this study was to develop a clinical laboratory method for subclass typing of human immunoglobulin G (IgG) paraproteins. Serum proteins were isoelectrically focused (IEF) in a mini-gel and passively blotted by capillary diffusion onto untreated nitrocellulose. Unreacted sites on the nitrocellulose wer...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Fasullo FJ Jr,Fritsche HA Jr,Liu FJ,Hamilton RG

    更新日期:1989-03-01 00:00:00

  • Acetate intolerance and an inhibitor of acetate utilization in hemodialysis patients.

    abstract::Diminished ability to utilize acetate (acetate intolerance) developed in a male patient on chronic hemodialysis after five years of maintenance dialysis. His ability to utilize lactate was also subnormal. We studied acetate metabolism in vitro by isolating lymphocytes from the patient's blood before dialysis and measu...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Egan JD,Wells IC

    更新日期:1979-03-01 00:00:00

  • Lipoprotein lipids in women with androgen excess: independent associations with increased insulin and androgen.

    abstract::Concentrations of triglycerides are increased and concentrations of high-density lipoprotein (HDL) cholesterol are low in women with hyperandrogenism. These alterations could be related to excessive androgen or estrogen, to hyperinsulinism, or to a combination of these abnormalities. We examined their independent infl...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Wild RA,Applebaum-Bowden D,Demers LM,Bartholomew M,Landis JR,Hazzard WR,Santen RJ

    更新日期:1990-02-01 00:00:00

  • Evaluation of nicked human chorionic gonadotropin content in clinical specimens by a specific immunometric assay.

    abstract::We report the development and characterization of an IRMA for the direct measurement of nicked human chorionic gonadotropin (hCGn) in blood and urine. hCGn derived from a reference preparation of hCG used as an immunogen elicits monoclonal antibodies (mAbs) with enhanced recognition of human luteinizing hormone epitop...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Kovalevskaya G,Birken S,Kakuma T,Schlatterer J,O'Connor JF

    更新日期:1999-01-01 00:00:00

  • Intra- and interindividual biological variation of five analytes used in assessing thyroid function: implications for necessary standards of performance and the interpretation of results.

    abstract::Intra- and interindividual components of biological variation have been determined for total thyroxin (TT4), free thyroxin (FT4), total triiodothyronine (TT3), free triiodothyronine (FT3), and thyrotropin (TSH). Calculated analytical goals (CV, %) for the precision required for optimal patient care are: TT4 less than ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Browning MC,Ford RP,Callaghan SJ,Fraser CG

    更新日期:1986-06-01 00:00:00

  • Analytical performance of EMIT cyclosporine assay evaluated.

    abstract::We evaluated the EMIT Cyclosporine Assay (Syva Co., Palo Alto, CA), using the Cobas-Mira analyzer to assess the precision, accuracy, and analytical recovery from whole-blood samples supplemented with cyclosporine. We also performed comparative analysis of whole-blood samples containing cyclosporine from liver and kidn...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Dasgupta A,Saldana S,Desai M

    更新日期:1991-12-01 00:00:00

  • Diagnosis of acute myocardial infarction from two measurements of creatine kinase isoenzyme MB with use of nonparametric probability estimation.

    abstract::By using bivariate probability estimation for the diagnosis of acute myocardial infarction (AMI) we show how to overcome the difficulties encountered for patients whose clinical presentation is atypical and those encountered when multiple isoenzyme determinations are treated by univariate methods. We use the values fo...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Bernstein LH,Good IJ,Holtzman GI,Deaton ML,Babb J

    更新日期:1989-03-01 00:00:00

  • Use of precision profiles to evaluate precision of the automated leukocyte differential.

    abstract::The commonly used methods of assessing the precision of the automated leukocyte differential have certain drawbacks that affect the validity and comparability of results. In the present report, we introduce a procedure based on building precision profiles from a large number of within-run imprecision experiments. The ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Hübl W,Tlustos L,Bayer PM

    更新日期:1996-07-01 00:00:00

  • Cardiac troponin-I is not expressed in fetal and healthy or diseased adult human skeletal muscle tissue.

    abstract::Cardiac troponin-I (cTnI) is not found in sera of patients with skeletal muscle disease in the absence of myocardial injury. It is not known, however, whether trace amounts of cTnI are expressed in regenerating human skeletal muscle, as has been observed with creatine kinase MB. Using immunohistochemical and biochemic...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Bodor GS,Porterfield D,Voss EM,Smith S,Apple FS

    更新日期:1995-12-01 00:00:00

  • Incidental Detection of Maternal Neoplasia in Noninvasive Prenatal Testing.

    abstract:BACKGROUND:Noninvasive prenatal testing (NIPT) uses cell-free DNA (cfDNA) as an analyte to detect copy-number alterations in the fetal genome. Because maternal and fetal cfDNA contributions are comingled, changes in the maternal genome can manifest as abnormal NIPT results. Circulating tumor DNA (ctDNA) present in case...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2017.277517

    authors: Dharajiya NG,Grosu DS,Farkas DH,McCullough RM,Almasri E,Sun Y,Kim SK,Jensen TJ,Saldivar JS,Topol EJ,van den Boom D,Ehrich M

    更新日期:2018-02-01 00:00:00

  • Arylesterase in serum: elaboration and clinical application of a fixed-incubation method.

    abstract::A sensitive, specific, and simple method for determining serum or urine arylesterase (EC 3.1.1.2) is described. The enzyme acts on phenyl acetate to release phenol, which produces a stable indophenol dye with 4-aminoantipyrine and potassium ferricyanide. Arylesterase, a thiol enzyme, is reactivated by 2-mercaptoethano...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Lorentz K,Flatter B,Augustin E

    更新日期:1979-10-01 00:00:00

  • Challenges in the diagnosis of the antiphospholipid syndrome.

    abstract:BACKGROUND:The antiphospholipid syndrome (APS) is an important cause of acquired thromboembolic complications and pregnancy morbidity. Its diagnosis is based on clinical and laboratory criteria, defined by strict guidelines. The original clinical and laboratory criteria for the identification of APS patients were publi...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:10.1373/clinchem.2009.133678

    authors: Devreese K,Hoylaerts MF

    更新日期:2010-06-01 00:00:00

  • N-acetyl-beta-glucosaminidase isoenzymes in serum and urine of patients with diabetes mellitus.

    abstract::The isoenzyme pattern of N-acetyl-beta-glucosaminidase (NAG) in serum and urine was studied in two groups of patients with diabetes mellitus and in 30 control subjects. Total NAG activity was significantly (P less than 0.001) increased in the serum and urine of the 20 diabetics with vascular complications, but was ins...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Severini G,Aliberti LM,Di Girolamo M

    更新日期:1988-12-01 00:00:00

  • Hyperhomocysteinemia and myocardial expression of brain natriuretic peptide in rats.

    abstract:BACKGROUND:Hyperhomocysteinemia (HHcy) has been linked to impaired left ventricular function and clinical class in patients with chronic heart failure. We hypothesized that HHcy stimulates myocardial brain natriuretic peptide (BNP) expression and induces adverse left ventricular remodeling. METHODS:We randomized 50 ra...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2006.077859

    authors: Herrmann M,Taban-Shoma O,Hübner U,Pexa A,Kilter H,Umanskaya N,Straub RH,Böhm M,Herrmann W

    更新日期:2007-04-01 00:00:00

  • Clinical evaluation of a radiometric assay specific for creatine kinase isoenzyme MB.

    abstract::A new radiometric assay specific for creatine kinase isoenzyme MB was evaluated with respect to its precision and agreement with a conventional electrophoretic CK-MB assay for the diagnosis of myocardial infarction. The reference interval we find for serum CK-MB in healthy subjects is 0--30 micrograms/L. The coefficie...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Kwong TC,Rothbard RL,Biddle TL

    更新日期:1981-06-01 00:00:00

  • Determinants of plasma methylmalonic acid in a large population: implications for assessment of vitamin B12 status.

    abstract:BACKGROUND:Methylmalonic acid (MMA) in plasma or serum is widely used for assessment of vitamin B(12) status. However, data are sparse regarding factors, besides renal function, that may influence MMA concentrations. We searched for important determinants of plasma MMA in the general population. METHODS:In 6946 middle...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2009.128678

    authors: Vogiatzoglou A,Oulhaj A,Smith AD,Nurk E,Drevon CA,Ueland PM,Vollset SE,Tell GS,Refsum H

    更新日期:2009-12-01 00:00:00

  • Measurement of glycosylated hemoglobin on cellulose acetate membranes by mobile affinity electrophoresis.

    abstract::In this method for separating glycosylated from nonglycosylated hemoglobin in blood by electrophoresis on cellulose acetate membranes, we exploit the affinity of low-molecular-mass dextran sulfate for the nonglycosylated fraction, which increases the mobility of the latter relative to that of glycosylated hemoglobin. ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Ambler J,Janik B,Walker G

    更新日期:1983-02-01 00:00:00

  • A parallel revolution: payment for new in vitro diagnostic technologies.

    abstract::To secure a successful product in today's era of cost containment, manufacturers and developers of new in vitro diagnostic technologies must consider payment issues--coverage and reimbursement by healthcare insurers--as critical market forces that must be addressed in the business plan. Similar to the regulatory hurdl...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Ivor LP

    更新日期:1996-09-01 00:00:00

  • Comparison of enzyme immunoassay and gas chromatography for determination of carbamazepine and ethosuximide in human serum.

    abstract::Patients' sera were analyzed for carbamazepine and ethosuximide by enzyme immunoassay (x) and gas chromatography (y), and the results were compared. The correlation coefficients were: for carbamazepine, x vs. y 0.94 (n = 93); for ethosuximide, x vs. y 0.99 (n = 30). These results suggest that the two methods could be ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Sun L,Szafir I

    更新日期:1977-09-01 00:00:00

  • Multiplex tetra-primer amplification refractory mutation system PCR to detect 6 common germline mutations of the MUTYH gene associated with polyposis and colorectal cancer.

    abstract:BACKGROUND:We describe a simple tetra-primer amplification refractory mutation system PCR (T-ARMS-PCR) for detecting MUTYH mutations, which are associated with colorectal adenomas and colorectal cancer. METHODS:We designed specific T-ARMS-PCR assays for 6 mutations (Y165C, G382D, 1395_7delGGA, Y90X, 1103delC, and R231...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2005.060137

    authors: Piccioli P,Serra M,Gismondi V,Pedemonte S,Loiacono F,Lastraioli S,Bertario L,De Angioletti M,Varesco L,Notaro R

    更新日期:2006-04-01 00:00:00

  • Automated enhanced latex agglutination assay for rheumatoid factors in serum.

    abstract::This improved assay of rheumatoid factors in serum, described here for use with the Baker "Encore" centrifugal analyzer, is efficient, with 250-sample throughput per hour; reproducible, with between-batch CV = 5% and within-batch CV = 2% (mid-assay range); and results correlate well (r = 0.9) with those by other metho...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Winkles JW,Lunec J,Gray L

    更新日期:1989-02-01 00:00:00

  • Comparison between immunoturbidimetry, size-exclusion chromatography, and LC-MS to quantify urinary albumin.

    abstract:BACKGROUND:The accurate and precise measurement of urinary albumin is critical, since even minor increases are diagnostically sensitive indicators of renal disease, cardiovascular events, and risk for death. To gain insights into potential measurement biases, we systematically compared urine albumin measurements perfor...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:10.1373/clinchem.2008.107508

    authors: Shaikh A,Seegmiller JC,Borland TM,Burns BE,Ladwig PM,Singh RJ,Kumar R,Larson TS,Lieske JC

    更新日期:2008-09-01 00:00:00

  • Determination of tamoxifen and four metabolites in serum by low-dispersion liquid chromatography.

    abstract::In this assay of tamoxifen and four metabolites in human serum, the serum samples are deproteinized with an equal volume of acetonitrile, then injected into a small (0.21 X 2 cm) precolumn packed with 5-micron-diameter octadecylsilane (ODS) particles. The samples are concentrated on-column by equilibrating the column ...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Lien EA,Ueland PM,Solheim E,Kvinnsland S

    更新日期:1987-09-01 00:00:00

  • Effect of plasma triglyceride concentrations on the accuracy of immunoturbidimetric assays of apolipoprotein B.

    abstract::We have studied the influence of triglyceride-rich particles on the analytical bias of apolipoprotein B measurements by various immunoturbidimetric methods. Three commercially available methods grossly overestimate apolipoprotein B in samples with even moderately above-normal triglyceride concentrations. This effect i...

    journal_title:Clinical chemistry

    pub_type: 杂志文章

    doi:

    authors: Walmsley TA,Grant S,George PM

    更新日期:1991-05-01 00:00:00

  • Preanalytic and analytic sources of variations in C-reactive protein measurement: implications for cardiovascular disease risk assessment.

    abstract:BACKGROUND:C-reactive protein (CRP) is a widely recognized indicator of inflammation and is known to play an important role in atherogenesis. Recent prospective studies have demonstrated that increased CRP concentrations within the reference interval are a strong predictor of myocardial infarction, stroke, sudden cardi...

    journal_title:Clinical chemistry

    pub_type: 杂志文章,评审

    doi:10.1373/49.8.1258

    authors: Ledue TB,Rifai N

    更新日期:2003-08-01 00:00:00