Automated detection of the G20210A prothrombin mutation using the LCx® microparticle enzyme immunoassay

Gilchrist, Annalyn; Solomon, Natalie; Erickson, Dwight; Sikand, Anita; Bauer, Kenneth A.; Kruskall, Margot S.; Kocher, Olivier

doi:10.1016/s0009-8981(01)00655-6

Cited by 3 publications

(2 citation statements)

References 18 publications

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“…Studies varied greatly in the extent to which they described the population from which the participants came; only 17 studies adequately reported the setting or population from which the blood samples were obtained [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27]. Most described the experimental test adequately; 60 to 70% of the studies gave a detailed description of their reference methods.…”

Section: Resultsmentioning

confidence: 99%

“…The concordance rates between the experimental methods and the reference standards for the detection of prothrombin G20210A were 100% in nearly all of the 23 studies, Table II. Three studies had some initial discordance comparing ELISA with direct sequencing or PCR-RFLP (0 to 2%), which upon repetition completely resolved [24,36,53]. Alsmadi et al and Pecheniuk et al reported concordance rates of 99.5 and 99%, respectively [16,49].…”

Section: Detection Of Prothrombin G20210amentioning

confidence: 99%

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Analytic validity of genetic tests to identify factor V Leiden and prothrombin G20210A

et al. 2010

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The objective of this study is to systematically review methods for detecting Factor V Leiden or prothrombin G20210A. English-language literature from MEDLINE 1 , EMBASE 1 , The Cochrane Library, the Cumulative Index to Nursing and Allied Health Literature, PsycInfo , 2000-December 2008. Studies assessed methods for detection of these mutations in at least 10 human blood samples and reported concordance, discordance, or reproducibility. Two investigators abstracted data on the sample selection criteria, test operators, DNA extraction, experimental test, reference standard, commercial instruments, concordance rates, explanation of any discordance, and whether discordance resolved after repetition. We assessed strength of the evidence using the GRADE criteria. We reviewed 7,777 titles and included 66 articles. The majority of the reviewed studies used PCR-RFLP or AS-PCR as the reference standard. The studies demonstrated that commercially available and precommercial tests have high analytic validity with all having greater than 99% concordance with the reference standard. With a few exceptions, discordance resolved with repetition of the test, suggesting operator or administrative errors were responsible for the discordant results. In the quality assurance studies, greater than 98% of laboratories demonstrated high, even perfect, accuracy when asked to diagnose a sample with a known mutation. The majority of errors came from a limited number of laboratories. Although not all methods may be accurate, there is high-grade evidence that genetic tests for the detection of FVL and prothrombin G20210A have excellent analytic validity. There is high-grade evidence that most, but not all, clinical laboratories test for FVL and prothrombin G20210A accurately. Am. J. Hematol. 85:264-270, 2010. V

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Section: Resultsmentioning

confidence: 99%

Section: Detection Of Prothrombin G20210amentioning

confidence: 99%

Analytic validity of genetic tests to identify factor V Leiden and prothrombin G20210A

et al. 2010

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Impact of hemostatic gene single point mutations in patients with non-diabetic coronary artery disease

et al. 2009

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Single point mutations in the genes coding for hemostatic factors were shown to be major inherited predisposing factors for venous thromboembolism. However, their contribution in the development of non-diabetic coronary artery disease [nDCAD] remains controversial. Angiographically demonstrated nDCAD patients (n = 86) and healthy controls (n = 90) were included in the study. Genotype analysis of hemostatic gene polymorphisms were assessed by using CVD strip assay, based on allele specific oligonucleotide probes. The carrier frequency of factor V (FV) H1299R, prothrombin G20210A, glycoprotein (Gp) IIIa L33P, plasminogen activator inhibitor-I (PAI-1) 4G/5G, 4G/4G, 5G/5G, methylenetetrahydrofolate reductase (MTHFR) A1298C and beta-fibrinogen -455 G > A were similar between patients and controls. In contrast, frequency of FV Leiden was significantly higher among patients (12.5%) than controls (5%, OR: 7.94; 95%CI: 1.9-49.6) and FXIII V34L was significantly lower among patients (23.7%) than controls (40%, OR: 0.24; 95%CI: 0.1-0.89). In addition, the frequency of the MTHFR C677T polymorphism was 32.5% among patients compared with 42.5% in controls, of which the T/T genotype was significantly lower among patients (5%) than controls (17.5%, OR: 0.06; 95%CI: 0.01-0.58). No difference was observed in prevalence of prothrombin G20210A, FV H1299R, Gp IIIa L33P, PAI-1 4G5G, MTHFR A1298C, beta fibrinogen 455 G > A mutations between patients and controls. However, lower frequency of FXIII Val34Leu and MTHFR C677T polymorphisms may decrease, while FV Leiden polymorphism may increase development of nDCAD.

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Capture and Detection of Biomolecules Using Dual Colloid Particles

Perrin¹

2003

Surfactant Science

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Automated detection of the G20210A prothrombin mutation using the LCx® microparticle enzyme immunoassay

Cited by 3 publications

References 18 publications

Analytic validity of genetic tests to identify factor V Leiden and prothrombin G20210A

Analytic validity of genetic tests to identify factor V Leiden and prothrombin G20210A

Impact of hemostatic gene single point mutations in patients with non-diabetic coronary artery disease

Capture and Detection of Biomolecules Using Dual Colloid Particles

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