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Sensitivity and Specificity

Clinical Research · NLM MeSH · updated 2026-10-29 · version 1

Citations verified against PubMedNot yet clinician-reviewed10 referencesApproximately 5 min read

Binary classification measures to assess test results.

Table of Contents

1. Definition2. Research landscape3. Reading the evidence4. Open-access studies5. Key reviews6. References7. About this article

Definition and research guide

This page combines a MeSH definition, publication statistics and selected research abstracts. It is a starting point for reading the literature, not a medical textbook or a systematic evidence review.

Content available: 4 complete abstracts (916 words), 10 references. Full article text is not stored or reproduced here; follow the PMID, DOI or PMC links to read the original sources and their access terms.

Definition

Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)

Definition: NLM Medical Subject Headings (MeSH) scope note (Public domain (U.S. National Library of Medicine); attribution requested). View the MeSH record.

Also known as: Specificity and Sensitivity; Sensitivity; Specificity.

Where it fits in the MeSH classification

Broader topics
Epidemiologic Research Design; Statistics as Topic; Mathematical Concepts
Narrower topics
Predictive Value of Tests; ROC Curve; Signal-To-Noise Ratio; Limit of Detection
See also
Diagnostic Techniques and Procedures

Research landscape

PubMed indexes 729,772 records tagged with the MeSH heading “Sensitivity and Specificity” (counts retrieved 2026-10-29). 145,372 of them (19.9%) were published from 2020 onward, and the busiest period so far is 2010-2019 with 287,133 records.

Reviews account for 53,733 records (7.4%) and meta-analyses for 10,190. Randomized controlled trials number 12,202 (1.7%) as a share of all records on the topic. Randomized trials make up only a small share of this literature, so much of what is known comes from laboratory, observational or descriptive work.

PubMed records by publication periodthrough 1999: 77,734 records; 2000-2009: 219,533 records; 2010-2019: 287,133 records; 2020 onward: 145,372 records77,734through 1999219,5332000-2009287,1332010-2019145,3722020 onward
Records in PubMed indexed with this heading, by publication period. Real counts from NCBI E-utilities; the final period covers only part of the current year. Volume reflects how much has been published, not how strong the evidence is.
Show the data
PeriodRecords
through 199977,734
2000-2009219,533
2010-2019287,133
2020 onward145,372
Share of records by publication typeReviews: 7.4 percent; Meta-analyses: 1.4 percent; Randomized controlled trials: 1.7 percentReviews7.4% (53,733)Meta-analyses1.4% (10,190)Randomized controlled trials1.7% (12,202)
Share of all PubMed records on this heading that carry each publication type. Types overlap with other records, so the shares do not sum to 100%.
Publication-type chart data
Publication types among 729,772 PubMed records
TypeRecordsShare
Reviews53,7337.4%
Meta-analyses10,1901.4%
Randomized controlled trials12,2021.7%

Method: PubMed query "Sensitivity and Specificity"[MeSH Terms] with publication-type and date filters, retrieved 2026-10-29.

Reading the evidence in clinical research

Research methods determine how much a result can be trusted. Randomized trials guard against confounding, systematic reviews and meta-analyses combine many studies, and observational designs are valuable but can show only association. Reporting standards, trial registration and pre-specified outcomes reduce bias. When reading about a method, ask what problem it is designed to solve and which problems it does not solve.

Evidence from open-access studies

These open-access studies come from PubMed’s best-match results for this heading (papers whose main topic it is), ranked here by citation count, with one recent addition. Each abstract is reproduced in full under its recorded open licence so that you can read the authors’ own words. They illustrate the literature; they are not a systematic summary of it. Citation counts measure attention, not reliability or clinical benefit.

Study comparison — selected abstracts, not a systematic review
Study / authorsYearSource label / designEurope PMC citationsLicence / source
Area under the ROC Curve has the most consistent evaluation for binary classification
Li J
2024Research article
Design not recorded in structured metadata
20cc by
PMID 39715186 · DOI · PMC11666033
Anti-integrin αvβ6 autoantibody in primary sclerosing cholangitis: a Japanese nationwide study
Yasuda M, Shiokawa M, Kuwada T, Nishikawa Y, Nakanishi R, Takimoto I, et al.
2025Research article
Design not recorded in structured metadata
15cc by
PMID 39549066 · DOI · PMC11717786
Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study
Sossen B, Székely R, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, et al.
2024Research article
Design not recorded in structured metadata
14cc by
PMID 39577975 · DOI · PMC11584317
Electromagnetic Noise Characterization and Suppression in Low-Field MRI Systems
Guallart-Naval T, Algarín JM, Alonso J
2026Research article
Design not recorded in structured metadata
5cc by
PMID 41546108 · DOI · PMC12962213

Area under the ROC Curve has the most consistent evaluation for binary classification [1]

Research article Li J · · 2024 · cited 20 times (Europe PMC)

Abstract reading summary — source excerpts
Opening excerpt
The proper use of model evaluation metrics is important for model evaluation and model selection in binary classification tasks.
Closing excerpt
The results have significant implications for model evaluation and model selection in binary classification tasks.
Interpretation limits
Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (183 words)

The proper use of model evaluation metrics is important for model evaluation and model selection in binary classification tasks. This study investigates how consistent different metrics are at evaluating models across data of different prevalence while the relationships between different variables and the sample size are kept constant. Analyzing 156 data scenarios, 18 model evaluation metrics and five commonly used machine learning models as well as a naive random guess model, I find that evaluation metrics that are less influenced by prevalence offer more consistent evaluation of individual models and more consistent ranking of a set of models. In particular, Area Under the ROC Curve (AUC) which takes all decision thresholds into account when evaluating models has the smallest variance in evaluating individual models and smallest variance in ranking of a set of models. A close threshold analysis using all possible thresholds for all metrics further supports the hypothesis that considering all decision thresholds helps reduce the variance in model evaluation with respect to prevalence change in data. The results have significant implications for model evaluation and model selection in binary classification tasks.

Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 39715186 · DOI · PMC11666033

Anti-integrin αvβ6 autoantibody in primary sclerosing cholangitis: a Japanese nationwide study [2]

Research article Yasuda M, Shiokawa M, Kuwada T, Nishikawa Y, Nakanishi R, Takimoto I, et al. · · 2025 · cited 15 times (Europe PMC)

Abstract reading summary — source excerpts
Opening excerpt
BackgroundAlthough specific biomarkers for primary sclerosing cholangitis (PSC) are required, no such biomarkers have been identified.
Closing excerpt
This study provides further evidence that anti-integrin αvβ6 autoantibodies are a useful biomarker for diagnosing PSC.
Interpretation limits
Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (147 words)

BackgroundAlthough specific biomarkers for primary sclerosing cholangitis (PSC) are required, no such biomarkers have been identified. We previously reported that patients with PSC had anti-integrin αvβ6 autoantibodies at only two hospitals. In this study, we aimed to validate the accuracy of the autoantibodies in diagnosing PSC using the newly developed Anti-integrin αvβ6 enzyme-linked immunosorbent assay (ELISA) Kit, which enables quantitation and comparison of antibodies among different facilities.MethodsOverall, 81 patients with PSC in a Japanese PSC registry recruited from 17 medical centers and hospitals, and 358 controls were enrolled. We retrospectively assessed anti-integrin αvβ6 autoantibodies using the Anti-integrin αvβ6 ELISA Kit and in-house ELISA.ResultsAnti-Integrin αvβ6 ELISA Kit and in-house ELISA exhibited a significant correlation (r = 0.97, P ConclusionsWe validated that anti-integrin αvβ6 autoantibodies have high sensitivity and specificity for diagnosing PSC. This study provides further evidence that anti-integrin αvβ6 autoantibodies are a useful biomarker for diagnosing PSC.

Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 39549066 · DOI · PMC11717786

Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study [3]

Research article Sossen B, Székely R, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, et al. · · 2024 · cited 14 times (Europe PMC)

Abstract reading summary — source excerpts
Opening excerpt
BackgroundDiagnostic delays for tuberculosis are common, with high resultant mortality.
Closing excerpt
FundingGlobal Health Innovative Technology Fund, KfW Development Bank, Commonwealth of Australia represented by the Department of Foreign Affairs and Trade, and the Netherlands Enterprise Agency.
Interpretation limits
Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (422 words)

BackgroundDiagnostic delays for tuberculosis are common, with high resultant mortality. Urine-Xpert Ultra (Cepheid) could improve time to diagnosis of tuberculosis disease and rifampicin resistance. We previously reported on lot-to-lot variation of the Fujifilm SILVAMP TB LAM. In this prespecified secondary analysis of the same cohort, we aimed to determine the diagnostic yield and accuracy of Urine-Xpert Ultra for tuberculosis in people with HIV, compared with an extended microbiological reference standard (eMRS) and composite reference standard (CRS) and also compared with Determine TB LAM Ag (AlereLAM, Abbott).MethodsIn this prospective, multicentre, diagnostic accuracy study, we recruited consecutive inpatients and outpatients (aged ≥18 years) with HIV from 13 hospitals and clinics in seven countries (Malawi, South Africa, Tanzania, Thailand, Uganda, Viet Nam, and Zambia). Patients with no isoniazid preventive therapy in the past 6 months and fewer than three doses of tuberculosis treatment in the past 60 days were included. Reference and index testing was performed in real time. The primary outcome of this secondary analysis was the diagnostic yield and accuracy of Urine-Xpert Ultra compared with the eMRS and CRS. Diagnostic accuracy was compared with AlereLAM and diagnostic yield was compared with both AlereLAM and Sputum-Xpert Ultra. This study was registered with ClinicalTrials.gov, NCT04089423, and is complete.FindingsBetween Dec 13, 2019, and Aug 5, 2021, 3528 potentially eligible individuals were screened and 1731 were enrolled, of whom 1602 (92·5%) were classifiable by the eMRS (median age 40 years [IQR 33-48], 838 [52·3%] of 1602 were female, 764 [47·7%] were male, 937 [58·5%] were outpatients, 665 [41·5%] were inpatients, median CD4 count was 374 cells per μL [IQR 138-630], and 254 [15·9%] had microbiologically confirmed tuberculosis). Against eMRS as reference, sensitivities of Urine-Xpert Ultra and AlereLAM were 32·7% (95% CI 27·2-38·7) and 30·7% (25·4-36·6) and specificities were 98·0% (97·1-98·6) and 90·4% (88·7-91·8), respectively. Against CRS as reference, sensitivities of Urine-Xpert Ultra and AlereLAM were 21·1% (95% CI 17·6-25·1), and 30·5% (26·4-34·9), and specificities were 99·1% (98·3-99·6) and 95·1% (93·5-96·3), respectively. The combination of Sputum-Xpert Ultra with AlereLAM or Urine-Xpert Ultra diagnosed 202 (77·1%) and 204 (77·9%) of 262 eMRS-positive participants, respectively, in incompletely overlapping groups; combining all three tests diagnosed 214 (81·7%) of 262 eMRS-positive participants INTERPRETATION: Urine-Xpert Ultra could offer promising clinical utility in addition to AlereLAM and Sputum-Xpert Ultra. In inpatient settings where both AlereLAM and Urine-Xpert Ultra are possible, both should be offered to support rapid diagnosis and treatment.FundingGlobal Health Innovative Technology Fund, KfW Development Bank, Commonwealth of Australia represented by the Department of Foreign Affairs and Trade, and the Netherlands Enterprise Agency.

Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 39577975 · DOI · PMC11584317

Electromagnetic Noise Characterization and Suppression in Low-Field MRI Systems [4]

Research article Guallart-Naval T, Algarín JM, Alonso J · · 2026 · cited 5 times (Europe PMC)

Abstract reading summary — source excerpts
Opening excerpt
PurposeOur goal is to develop and validate a practical protocol that guides users in identifying and suppressing electromagnetic noise in low-field MRI systems, enabling operation near the thermal noise limit.
Closing excerpt
The framework also provides actionable guidance for the integration of additional system components, such as gradient drivers and automatic tuning networks, without compromising signal-to-noise ratio (SNR).
Interpretation limits
Verbatim excerpts from the authors’ abstract; the closing excerpt may describe a finding, limitation or recommendation. Design, population, effect size and uncertainty have not been independently extracted or appraised. Read the complete abstract and linked paper before interpreting the findings.
Read complete abstract (164 words)

PurposeOur goal is to develop and validate a practical protocol that guides users in identifying and suppressing electromagnetic noise in low-field MRI systems, enabling operation near the thermal noise limit.MethodsWe present a systematic, stepwise methodology that includes diagnostic measurements, hardware isolation strategies, and good practices for cabling and shielding. Each step is validated with corresponding noise measurements under increasingly complex system configurations, both unloaded and with a human subject present.ResultsNoise levels were monitored through the incremental assembly of a low-field MRI system, revealing key sources of EMI and quantifying their impact. Final configurations achieved noise within 1.5 ×$$ \times $$ the theoretical thermal bound with a subject in the scanner. Image reconstructions illustrate the direct relationship between system noise and image quality.ConclusionThe proposed protocol enables low-field MRI systems to operate close to fundamental noise limits in realistic conditions. The framework also provides actionable guidance for the integration of additional system components, such as gradient drivers and automatic tuning networks, without compromising signal-to-noise ratio (SNR).

Abstract reproduced from the open-access article under the recorded cc by licence; © the authors. PMID 41546108 · DOI · PMC12962213

Key reviews and meta-analyses

The most cited review-type papers among PubMed’s best-match results for this heading, listed with bibliographic details only. Follow the links for the full text and access terms.

  • Research article Diagnostic accuracy of the Berlin questionnaire, STOP-BANG, STOP, and Epworth sleepiness scale in detecting obstructive sleep apnea: A bivariate meta-analysis [5]
    Chiu HY, Chen PY, Chuang LP, Chen NH, Tu YK, Hsieh YJ, et al. · Sleep Med Rev · 2017 · cited 432 times (Europe PMC)
  • Research article Receiver operating characteristics (ROCs) in recognition memory: a review [6]
    Yonelinas AP, Parks CM · Psychol Bull · 2007 · cited 265 times (Europe PMC)
  • Research article Repetition suppression and its contextual determinants in predictive coding [7]
    Auksztulewicz R, Friston K · Cortex · 2016 · cited 259 times (Europe PMC)
  • Research article Diagnostic accuracy measures [8]
    Eusebi P · Cerebrovasc Dis · 2013 · cited 208 times (Europe PMC)
  • Research article Idiosyncratic drug reactions: current understanding [9]
    Uetrecht J · Annu Rev Pharmacol Toxicol · 2007 · cited 198 times (Europe PMC)
  • Research article Filters: When, Why, and How (Not) to Use Them [10]
    de Cheveigné A, Nelken I · Neuron · 2019 · cited 164 times (Europe PMC)

References

  1. Li J. Area under the ROC Curve has the most consistent evaluation for binary classification. . 2024. PMID 39715186 · DOI · PMC11666033
  2. Yasuda M, Shiokawa M, Kuwada T, Nishikawa Y, Nakanishi R, Takimoto I, et al.. Anti-integrin αvβ6 autoantibody in primary sclerosing cholangitis: a Japanese nationwide study. . 2025. PMID 39549066 · DOI · PMC11717786
  3. Sossen B, Székely R, Mukoka M, Muyoyeta M, Nakabugo E, Hella J, et al.. Urine-Xpert Ultra for the diagnosis of tuberculosis in people living with HIV: a prospective, multicentre, diagnostic accuracy study. . 2024. PMID 39577975 · DOI · PMC11584317
  4. Guallart-Naval T, Algarín JM, Alonso J. Electromagnetic Noise Characterization and Suppression in Low-Field MRI Systems. . 2026. PMID 41546108 · DOI · PMC12962213
  5. Chiu HY, Chen PY, Chuang LP, Chen NH, Tu YK, Hsieh YJ, et al.. Diagnostic accuracy of the Berlin questionnaire, STOP-BANG, STOP, and Epworth sleepiness scale in detecting obstructive sleep apnea: A bivariate meta-analysis. Sleep Med Rev. 2017. PMID 27919588 · DOI
  6. Yonelinas AP, Parks CM. Receiver operating characteristics (ROCs) in recognition memory: a review. Psychol Bull. 2007. PMID 17723031 · DOI
  7. Auksztulewicz R, Friston K. Repetition suppression and its contextual determinants in predictive coding. Cortex. 2016. PMID 26861557 · DOI · PMC5405056
  8. Eusebi P. Diagnostic accuracy measures. Cerebrovasc Dis. 2013. PMID 24135733 · DOI
  9. Uetrecht J. Idiosyncratic drug reactions: current understanding. Annu Rev Pharmacol Toxicol. 2007. PMID 16879083 · DOI
  10. de Cheveigné A, Nelken I. Filters: When, Why, and How (Not) to Use Them. Neuron. 2019. PMID 30998899 · DOI

About this article

Sources
NLM Medical Subject Headings (definition, synonyms); NCBI PubMed (counts, identifiers); Europe PMC (open-access abstracts and citation counts).
Verification
Every reference was resolved against PubMed on 2026-10-31; title, year and DOI matched.
Review state
automated source verified; no human expert review has been recorded yet.
Version
1, last updated 2026-10-29.

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At a glance

729,772
PubMed records on this heading
20%
published since 2020
53,733
review articles
12,202
randomized trials
10
verified references below

Counts come from PubMed on 2026-10-29; they show how much has been written, not how strong the evidence is.

Related topics See all →

  • ROC CurveClinical Research
  • Cardiometabolic Risk FactorsClinical Research
  • Cluster AnalysisClinical Research
  • Confidence IntervalsClinical Research
  • Discriminant AnalysisClinical Research

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