False-Positive hCG Assay Results Leading to Unnecessary Surgery and Chemotherapy and Needless Occurrences of Diabetes and Coma

Cole, Laurence A.; Rinne, Kirsi; Shahabi, Shohreh; Omrani, Aziza

doi:10.1093/clinchem/45.2.313

Cited by 80 publications

(22 citation statements)

References 4 publications

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“…False positive serum βhCG tests have been described in numerous reports; in many cases these have resulted in unnecessary, and even irreversible, medical procedures such as bilateral salpingo‐oophorectomy and hysterectomy [4,6–11]. Here we show that up to 30% of the IgA deficient sera analysed lead to a false positive pregnancy test.…”

Section: Discussionmentioning

confidence: 63%

“…These assays are also essential for the successful monitoring of treatment for gestational trophoblastic disease [2,3]. If the serum to be tested contains a heterophile antibody to the animal immune globulin, false positive results can be obtained [4–7]. While uncommon, false positive hCG tests can result in unnecessary medical care and in some cases, unnecessary medications and irreversible surgical procedures [4,6–11].…”

Section: Introductionmentioning

confidence: 99%

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Frequent false positive beta human chorionic gonadotropin tests in immunoglobulin A deficiency

Knight

Bingemann

Cole

et al. 2005

Clinical and Experimental Immunology

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Section: Discussionmentioning

confidence: 63%

Section: Introductionmentioning

confidence: 99%

Frequent false positive beta human chorionic gonadotropin tests in immunoglobulin A deficiency

Knight

Bingemann

Cole

et al. 2005

Clinical and Experimental Immunology

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“…Mass spectrometry has shown that many types of tubes shed polymeric materials into samples and these may interfere with some types of analysis such as protein profiling (10). These inappropriate results could lead to inappropriate therapeutic decisions with devasting consequences (11). On the contrary, facilitating the collection procedure by simplifying the process using the same collection tube for different analysis could reduce not only the time needed to obtain results but also the economic costs.…”

Section: Discussionmentioning

confidence: 99%

Different collection tubes in cardiac biomarkers detection

Daves

Trevisan

Cemin

2008

Clinical Laboratory Analysis

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The role played by different collection tubes is one of the more frequently forgotten parameters, which influences the quality of laboratory results.We aimed to determine whether there is a significant difference in assay of myoglobin, cardiac troponin I, and CK-MB depending on the presence of anticoagulant and gel separator in the collecting tubes.Blood samples were collected in 40 consecutive patients admitted for acute coronary syndrome. The samples were taken at the same moment in three different tubes (tubes without anticoagulant and with gel separator, heparin tubes with gel separator and heparin tubes without gelseparator;Venosafe, Terumo Europe, Leuven Belgium). Myoglobin, CK-MB and cardiac troponin I were measured with a double side (sandwich) chemiluminescent immuenzymatic assay (Access Myoglobin, Access CK-MB, Access AccuTnI).Cardiac troponin I was not influenced by the type of collection tube used. On the contrary, myoglobin and CK-MB showed a statistical difference depending on the test tube. In particular, there was a significant difference between tubes without anticoagulant and with gel separator and tubes with heparin and without gel.

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“…Interference by human anti-mouse antibody was confirmed as the source of the assay error; the woman had no cancer. This was not an isolated case; Rotmensch and Cole (21 ) and Cole et al (22 ) found that in 78 cases, there were 35 instances of false-positive errors with 12 cases of unnecessary cancer therapy. A survey (12 ) of performance complaints showed that previously unknown clinically important interference errors in diagnostic assays were the most frequent error source reported.…”

Section: Clinicians and Laboratory Errormentioning

confidence: 94%

Critique of the Guide to the Expression of Uncertainty in Measurement Method of Estimating and Reporting Uncertainty in Diagnostic Assays

Krouwer¹

2003

Clinical Chemistry

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Background:The Guide to the Expression of Uncertainty in Measurement (GUM) provides instructions for constructing uncertainty intervals for a measurement. This method is usually reserved for reference materials, but GUM has been recently proposed as a way to express uncertainty for commercial diagnostic assays. Methods: Using the official GUM standard and published applications of GUM to commercial diagnostic assays, I undertook an analysis to evaluate whether applying GUM to commercial diagnostic assays is warranted. Results: Certain important assays, such as troponin I, would not be candidates for GUM because troponin I is not a well-defined physical quantity. Unlike definitive methods, in which efforts are taken to detect and eliminate all systematic error sources, commercial assays often trade off features such as ease of use and cost with accuracy and allow systematic errors to be present as long as the overall accuracy meets the medical need goal. Laboratories are hindered in preparing GUM models because the knowledge required to specify some systematic errors is often available only to manufacturers. Some non-GUM methods to estimate uncertainty rely on observed data, which include both known and unknown sources of error. The occurrence of large, unknown errors for assays in routine use (e.g., outliers) is not unusual because diagnostic assays must be chemically specific in the presence of thousands of potentially interfering substances. There is no provision in GUM to deal with unexplained outliers, which may lead to uncertainty intervals that are not wide enough. Some clinicians assume that diagnostic assay results have little uncertainty. This situation may be made worse by including an uncertainty interval, which implies certification. Conclusions: Evaluations for accuracy (total analytical error) based on describing the distribution of result differences between commercial assays and reference methods indicate that some assays have a few results with large differences (e.g., outliers). This leads to a wide accuracy interval (total analytical error limits). It is unlikely that GUM would be able to predict these wide intervals, especially because there is little or no provision for outlier treatment in GUM. Presenting too narrow GUM uncertainty intervals to clinicians would be misleading. The modeling used by practitioners of the GUM method is potentially useful in improving quality, but commercial diagnostic assays are not ready for GUM uncertainty statements. © 2003 American Association for Clinical ChemistryAccuracy, the closeness in agreement between a test result and an accepted reference method, is a concept well known to clinical chemists. Inaccuracy, the lack of closeness in agreement (also called total analytical error), is caused by random and systematic errors. (3, 4 ). Kristiansen (5 ) described how GUM applies to diagnostic assays. Here I will describe problems with the GUM method with respect to its use for routine diagnostic assays. Kallner (6 ) and the NIST web site (7 ) provide excelle...

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False-Positive hCG Assay Results Leading to Unnecessary Surgery and Chemotherapy and Needless Occurrences of Diabetes and Coma

Cited by 80 publications

References 4 publications

Frequent false positive beta human chorionic gonadotropin tests in immunoglobulin A deficiency

Frequent false positive beta human chorionic gonadotropin tests in immunoglobulin A deficiency

Different collection tubes in cardiac biomarkers detection

Critique of the Guide to the Expression of Uncertainty in Measurement Method of Estimating and Reporting Uncertainty in Diagnostic Assays

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