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A systematic review of test accuracy studies evaluating molecular micro-satellite instability testing for the detection of individuals with lynch syndrome.

ABSTRACT: A systematic review was conducted to assess the diagnostic test accuracy of polymerase chain reaction (PCR)-based microsatellite instability (MSI) testing for identifying Lynch syndrome in patients with colorectal cancer (CRC). Unlike previous reviews, this was based on assessing MSI testing against best practice for the reference standard, and included CRC populations that were unselected, age-limited or high-risk for Lynch syndrome.Single- and two-gate diagnostic test accuracy studies, or similar, were identified, assessed for inclusion, data extracted and quality appraised by two reviewers according to a pre-specified protocol. Sensitivity of MSI testing was estimated for all included studies. Specificity, likelihood ratios and predictive values were estimated for studies that were not based on high-risk samples. Narrative synthesis was conducted.Nine study samples were included. When MSI-Low results were considered to be negative, sensitivity estimates ranged from 67% (95% CI 47, 83) to 100% (95% CI 94, 100). Three studies contributed to estimates of both sensitivity and specificity, with specificity ranging from 61% (95% CI 57, 65), to 93% (95% CI 89, 95). Good sensitivity was achieved at the expense of specificity. When MSI-L was considered to be positive (effectively lowering the threshold for a positive index test result) sensitivity increased and specificity decreased. Between-study heterogeneity in both the MSI and reference standard testing, combined with the low number of studies contributing to both sensitivity and specificity estimates, precluded pooling by meta-analysis.MSI testing is an effective screening test for Lynch syndrome. However, there is significant uncertainty surrounding what balance of sensitivity and specificity will be achieved in clinical practice and how this relates to specific characteristics of the test (such as the panel of markers used or the thresholds used to denote a positive test).

SUBMITTER: Coelho H

PROVIDER: S-EPMC5723028 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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A systematic review of test accuracy studies evaluating molecular micro-satellite instability testing for the detection of individuals with lynch syndrome.

Coelho Helen H Jones-Hughes Tracey T Snowsill Tristan T Briscoe Simon S Huxley Nicola N Frayling Ian M IM Hyde Chris C

BMC cancer 20171208 1

<h4>Background</h4>A systematic review was conducted to assess the diagnostic test accuracy of polymerase chain reaction (PCR)-based microsatellite instability (MSI) testing for identifying Lynch syndrome in patients with colorectal cancer (CRC). Unlike previous reviews, this was based on assessing MSI testing against best practice for the reference standard, and included CRC populations that were unselected, age-limited or high-risk for Lynch syndrome.<h4>Methods</h4>Single- and two-gate diagno ...[more]

PMID: 29221446

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Project description:ObjectivesTo review evaluations of the diagnostic accuracy of coronavirus disease 2019 (COVID-19) rapid antigen tests (RATs) approved by the Therapeutic Goods Administration (TGA) for self-testing by ambulatory people in Australia; to compare these estimates with values reported by test manufacturers.Study designSystematic review of publications in any language that reported cross-sectional, case-control, or cohort studies in which the participants were ambulatory people in the community or health care workers in hospitals in whom severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was suspected, and the results of testing self-collected biological samples with a TGA-approved COVID-19 RAT were compared with those of reverse transcription-polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Estimates of diagnostic accuracy (sensitivity, specificity) were checked and compared with manufacturer estimates published on the TGA website.Data sourcesPublications (to 1 September 2022) identified in the Cochrane COVID-19 Study Register and the World Health Organization COVID-19 research database. Information on manufacturer diagnostic accuracy evaluations was obtained from the TGA website.Data synthesisTwelve publications that reported a total of eighteen evaluations of eight RATs approved by the TGA for self-testing (manufacturers: All Test, Roche, Flowflex, MP Biomedicals, Clungene, Panbio, V-Chek, Whistling) were identified. Five studies were undertaken in the Netherlands, two each in Germany and the United States, and one each in Denmark, Belgium, and Canada; test sample collection was unsupervised in twelve studies, and supervised by health care workers or researchers in six. Estimated sensitivity with unsupervised sample collection ranged from 20.9% (MP Biomedicals) to 74.3% (Roche), and with supervised collection from 7.7% (V-Chek) to 84.4% (Panbio); the estimates were between 8.2 and 88 percentage points lower than the values reported by the manufacturers. Test specificity was high for all RATs (97.9-100%).ConclusionsThe risk of false negative results when using COVID-19 RATs for self-testing may be considerably higher than apparent in manufacturer reports on the TGA website, with implications for the reliability of these tests for ruling out infection.

Project description:Manual muscle testing (MMT) is a non-invasive assessment tool used by a variety of health care providers to evaluate neuromusculoskeletal integrity, and muscular strength in particular. In one form of MMT called muscle response testing (MRT), muscles are said to be tested, not to evaluate muscular strength, but neural control. One established, but insufficiently validated, application of MRT is to assess a patient's response to semantic stimuli (e.g. spoken lies) during a therapy session. Our primary aim was to estimate the accuracy of MRT to distinguish false from true spoken statements, in randomised and blinded experiments. A secondary aim was to compare MRT accuracy to the accuracy when practitioners used only their intuition to differentiate false from true spoken statements.Two prospective studies of diagnostic test accuracy using MRT to detect lies are presented. A true positive MRT test was one that resulted in a subjective weakening of the muscle following a lie, and a true negative was one that did not result in a subjective weakening of the muscle following a truth. Experiment 2 replicated Experiment 1 using a simplified methodology. In Experiment 1, 48 practitioners were paired with 48 MRT-naïve test patients, forming unique practitioner-test patient pairs. Practitioners were enrolled with any amount of MRT experience. In Experiment 2, 20 unique pairs were enrolled, with test patients being a mix of MRT-naïve and not-MRT-naïve. The primary index test was MRT. A secondary index test was also enacted in which the practitioners made intuitive guesses ("intuition"), without using MRT. The actual verity of the spoken statement was compared to the outcome of both index tests (MRT and Intuition) and their mean overall fractions correct were calculated and reported as mean accuracies.In Experiment 1, MRT accuracy, 0.659 (95% CI 0.623 - 0.695), was found to be significantly different (p?<?0.01) from intuition accuracy, 0.474 (95% CI 0.449 - 0.500), and also from the likelihood of chance (0.500; p?<?0.01). Experiment 2 replicated the findings of Experiment 1. Testing for various factors that may have influenced MRT accuracy failed to detect any correlations.MRT has repeatedly demonstrated significant accuracy for distinguishing lies from truths, compared to both intuition and chance. The primary limitation of this study is its lack of generalisability to other applications of MRT and to MMT.The Australian New Zealand Clinical Trials Registry (ANZCTR; www.anzctr.org.au ; ID # ACTRN12609000455268 , and US-based ClinicalTrials.gov (ID # NCT01066312 ).

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A systematic review of test accuracy studies evaluating molecular micro-satellite instability testing for the detection of individuals with lynch syndrome.

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A systematic review of test accuracy studies evaluating molecular micro-satellite instability testing for the detection of individuals with lynch syndrome.

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