Evaluation of diagnostic tests for infectious diseases: general principles

Banoo, Shabir; Bell, David; Bossuyt, Patrick M.; Herring, A. J.; Mabey, David; Poole, Freddie; Smith, P. G.; Sriram, N.; Wongsrichanalai, Chansuda; Linke, Ralf D.; O’Brien, Rick; Perkins, Mark D.; Cunningham, Jane; Matsoso, Precious; Nathanson, Carl Michael; Olliaro, Piero; Peeling, Rosanna W.; Ramsay, Andy

doi:10.1038/nrmicro1523

Cited by 249 publications

(72 citation statements)

References 11 publications

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“…Use of guidelines such as the Standards for Reporting of Diagnostic Accuracy (STARD) [79] and the tool for quality assessment of diagnostic accuracy studies (the QUADAS tool) [80] may lead to improvements in the quality of future studies. Guidelines specifically for the evaluation of diagnostic tests for infectious diseases have recently been published [81]. …”

Section: Discussionmentioning

confidence: 99%

Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review

et al. 2007

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BackgroundThe global tuberculosis epidemic results in nearly 2 million deaths and 9 million new cases of the disease a year. The vast majority of tuberculosis patients live in developing countries, where the diagnosis of tuberculosis relies on the identification of acid-fast bacilli on unprocessed sputum smears using conventional light microscopy. Microscopy has high specificity in tuberculosis-endemic countries, but modest sensitivity which varies among laboratories (range 20% to 80%). Moreover, the sensitivity is poor for paucibacillary disease (e.g., pediatric and HIV-associated tuberculosis). Thus, the development of rapid and accurate new diagnostic tools is imperative. Immune-based tests are potentially suitable for use in low-income countries as some test formats can be performed at the point of care without laboratory equipment. Currently, dozens of distinct commercial antibody detection tests are sold in developing countries. The question is “do they work?”Methods and FindingsWe conducted a systematic review to assess the accuracy of commercial antibody detection tests for the diagnosis of pulmonary tuberculosis. Studies from all countries using culture and/or microscopy smear for confirmation of pulmonary tuberculosis were eligible. Studies with fewer than 50 participants (25 patients and 25 control participants) were excluded. In a comprehensive search, we identified 68 studies. The results demonstrate that (1) overall, commercial tests vary widely in performance; (2) sensitivity is higher in smear-positive than smear-negative samples; (3) in studies of smear-positive patients, Anda-TB IgG by enzyme-linked immunosorbent assay shows limited sensitivity (range 63% to 85%) and inconsistent specificity (range 73% to 100%); (4) specificity is higher in healthy volunteers than in patients in whom tuberculosis disease is initially suspected and subsequently ruled out; and (5) there are insufficient data to determine the accuracy of most commercial tests in smear microscopy–negative patients, as well as their performance in children or persons with HIV infection.ConclusionsNone of the commercial tests evaluated perform well enough to replace sputum smear microscopy. Thus, these tests have little or no role in the diagnosis of pulmonary tuberculosis. Lack of methodological rigor in these studies was identified as a concern. It will be important to review the basic science literature evaluating serological tests for the diagnosis of pulmonary tuberculosis to determine whether useful antigens have been described but their potential has not been fully exploited. Activities leading to the discovery of new antigens with immunodiagnostic potential need to be intensified.

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Section: Discussionmentioning

confidence: 99%

Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review

et al. 2007

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“…The specificity in these studies was 100%, and a minimum sample size of 38 noninfected controls was estimated with a level of confidence of 95%:

\begin{matrix} T1 \\ n = z^{2} \cdot p \cdot \frac{(1 - p)}{x^{2}}, \end{matrix}

where p is the sensitivity or specificity and x 2 is the confidence interval (95%) [17]. …”

Section: Methodsmentioning

confidence: 99%

Development and Validation of a PCR-ELISA for the Diagnosis of Symptomatic and Asymptomatic Infection byLeishmania (Leishmania) infantum

Medeiros

Gomes

Oliveira

et al. 2017

Journal of Tropical Medicine

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A kDNA PCR enzyme-linked immunosorbent assay (kDNA PCR-ELISA) for the diagnosis of human visceral leishmaniasis (HVL) was developed. The detection limit of the reaction, precision measurements, and cut-off of the kDNA PCR-ELISA were defined in a proof-of-concept phase. A reference strain of Leishmania (Leishmania) infantum and a bank of 14 peripheral blood samples from immunocompetent patients with VL were characterized using techniques considered gold standards, and 11 blood samples obtained from healthy individuals of an endemic area were also assessed. Phase II evaluation determined the performance of the assay in peripheral blood samples from 105 patients with VL (adults and children), 25 patients with Leishmania/HIV coinfection, 40 healthy individuals, and 33 asymptomatic individuals living in endemic areas. The kDNA PCR-ELISA exhibited satisfactory precision, with a detection limit of 0.07 fg of DNA from L. (L.) infantum and 1 parasite/mL blood. The overall sensitivity of the assay for all groups studied was 100% (95% confidence interval [CI]: 97.1–100%), and the specificity was 95% (95% CI: 83.5–98.6%). The kDNA PCR-ELISA was shown to be a useful tool for VL symptomatic and asymptomatic individuals diagnosis and its use in endemic countries may help monitor control interventions.

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“…It has been recommended that the accuracy of rapid HIV tests should be evaluated by the actual test user and in the appropriate clinical settings. 22 As there has been limited reporting on the accuracy of HIV rapid tests in rural and resource-limited settings in South Africa, we sought to evaluate the accuracy and performance of HIV rapid test results and the time to report the HIV rapid test result to pregnant women in rural South Africa.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of antenatal rapid human immunodeficiency virus testing in rural South Africa

Mashamba-Thompson

Moodley

Sartorius

et al. 2018

South. Afr. j. HIV med.

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Introduction: South African guidelines recommend two rapid tests for diagnosing human immunodeficiency virus (HIV) using the serial HIV testing algorithm, but the accuracy and compliance to this algorithm is unknown in rural clinics. We evaluated the accuracy of HIV rapid testing and the time to receiving test results among pregnant women in rural KwaZulu-Natal (KZN).Method: We observed the accuracy of rapid HIV testing algorithms for 208 consenting antenatal patients accessing voluntary HIV testing services in nine rural primary healthcare (PHC) clinics in KZN. A PHC-based HIV counsellor obtained finger-prick whole blood from each participant to perform rapid testing using the Advanced Quality™ One Step anti-HIV (1&2) and/or ABON™ HIV 1/2/O Tri-Line HIV test. A research nurse obtained venous blood for an enzyme-linked immunosorbent assay (ELISA) HIV test, which is the gold standard diagnostic test. We recorded the time of receipt of HIV test results for each test.Results: Among 208 pregnant women with a mean age of 26 years, 72 women from nine rural PHC clinics were identified as HIV-positive by two rapid tests with an HIV-prevalence of 35% (95% Bayesian credibility intervals [BCI]: 28% – 41%). Of the 208 patients, 135 patients from six clinics were tested with the serial HIV testing algorithm. The estimated sensitivity and specificity for the 135 participants were 100% (95% confidence interval [CI]: 93% – 100%) and 99% (CI: 95% – 100%), respectively. The positive predictive value and negative predictive value were estimated at 98% (CI: 94% – 100%) and 95% (CI: 88% – 99%), respectively. All women received their HIV rapid test results within 20 min of testing. Test stock-out resulted in poor test availability at point-of-care, preventing performance of a second HIV test in three out of nine PHC clinics in rural KZN.Conclusion: Despite the poor compliance with national guidelines for HIV rapid testing services, HIV rapid test results provided to pregnant women in rural PHC clinics in KZN were generally accurate and timely. Test stock-out was shown to be one of the barriers to test availability in rural PHC clinics, resulting in poor compliance with guidelines. We recommend a compulsory confirmation HIV rapid test for all HIV-negative test results obtained from pregnant patients in rural and resource-limited settings.

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Evaluation of diagnostic tests for infectious diseases: general principles

Cited by 249 publications

References 11 publications

Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review

Commercial Serological Antibody Detection Tests for the Diagnosis of Pulmonary Tuberculosis: A Systematic Review

Development and Validation of a PCR-ELISA for the Diagnosis of Symptomatic and Asymptomatic Infection byLeishmania (Leishmania) infantum

Evaluation of antenatal rapid human immunodeficiency virus testing in rural South Africa

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