Fool's gold: Why imperfect reference tests are undermining the evaluation of novel diagnostics: A reevaluation of 5 diagnostic tests for leptospirosis

Clinical Infectious Diseases

Volumn 55, Issue 3, 2012, Pages 322-331

  Limmathurotsakul, Direk ^a   Turner, Elizabeth L ^e   Wuthiekanun, Vanaporn ^a   Thaipadungpanit, Janjira ^a   Suputtamongkol, Yupin ^c   Chierakul, Wirongrong ^a,b   Smythe, Lee D ^d   Day, Nicholas P J ^a,f   Cooper, Ben ^a   Peacock, Sharon J ^a,b,g  

^a MAHIDOL UNIVERSITY   (Thailand)

^b Faculty of Tropical Medicine   (Thailand)

^c MAHIDOL UNIVERSITY   (Thailand)

^d QUEENSLAND HEALTH   (Australia)

^e LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^f UNIVERSITY OF OXFORD   (United Kingdom)

^g UNIVERSITY OF CAMBRIDGE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AGGLUTINATION TEST; ARTICLE; BACTERIUM CULTURE; BACTERIUM DETECTION; BLOOD CULTURE; CLINICAL EVALUATION; DIAGNOSTIC ACCURACY; HUMAN; IMMUNOFLUORESCENCE TEST; INTERMETHOD COMPARISON; LATERAL FLOW TEST; LEPTOSPIRA; LEPTOSPIROSIS; META ANALYSIS; MICROSCOPIC AGGLUTINATION TEST; NONHUMAN; POINT OF CARE TESTING; POLYMERASE CHAIN REACTION; PREDICTIVE VALUE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); SENSITIVITY AND SPECIFICITY; SERODIAGNOSIS; SEROLOGY; THAILAND;

ADOLESCENT; ADULT; DIAGNOSTIC ERRORS; DIAGNOSTIC TESTS, ROUTINE; HUMANS; LEPTOSPIRA; LEPTOSPIROSIS; MICROSCOPY; MODELS, STATISTICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFERENCE STANDARDS; YOUNG ADULT;

EID: 84863965893     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cis403     Document Type: Article

References (30)

1. Suttinont C, Losuwanaluk K, Niwatayakul K, et al. Causes of acute, undifferentiated, febrile illness in rural Thailand: results of a prospective observational study. Ann Trop Med Parasitol 2006; 100:363-70.
2. Thaipadungpanit J, Chierakul W, Wuthiekanun V, et al. Diagnostic accuracy of real-time PCR assays targeting 16S rRNA and lipl32 genes for human leptospirosis in Thailand: a case-control study. PLoS One 2011; 6:e16236.
3. Wuthiekanun V, Chierakul W, Limmathurotsakul D, et al. Optimization of culture of Leptospira from humans with leptospirosis. J Clin Microbiol 2007; 45:1363-5.
4. Phimda K, Hoontrakul S, Suttinont C, et al. Doxycycline versus azithromycin for treatment of leptospirosis and scrub typhus. Antimicrob Agents Chemother 2007; 51:3259-63.
5. Wuthiekanun V, Sirisukkarn N, Daengsupa P, et al. Clinical diagnosis and geographic distribution of leptospirosis, Thailand. Emerg Infect Dis 2007; 13:124-6.
6. World Health Organization (WHO). Report of the first meeting of leptospirosis burden epidemiology reference group. Geneva: WHO, 2010;1-34.
7. Speybroeck N, Praet N, Claes F, et al. True versus apparent malaria infection prevalence: the contribution of a Bayesian approach. PLoS One 2011; 6:e16705.
8. Limmathurotsakul D, Jamsen K, Arayawichanont A, et al. Defining the true sensitivity of culture for the diagnosis of melioidosis using Bayesian latent class models. PLoS One 2010; 5:e12485.
9. Deeks JJ. Systematic reviews in health care: systematic reviews of evaluations of diagnostic and screening tests. BMJ 2001; 323:157-62.
10. Leeflang MM, Deeks JJ, Gatsonis C, Bossuyt PM. Systematic reviews of diagnostic test accuracy. Ann Intern Med 2008; 149:889-97.
11. Smits HL, Eapen CK, Sugathan S, et al. Lateral-flow assay for rapid serodiagnosis of human leptospirosis. Clin Diagn Lab Immunol 2001; 8:166-9.
12. Appassakij H, Silpapojakul K, Wansit R, Woodtayakorn J. Evaluation of the immunofluorescent antibody test for the diagnosis of human leptospirosis. Am J Trop Med Hyg 1995; 52:340-3.
13. Zhou XM, Mcclish DK, Obuchowski NA. Methods for correcting imperfect standard bias. In: Statistical methods in diagnostic medicine. 1st ed. New York: Wiley-Interscience, 2002:40.
14. Joseph L, Gyorkos TW, Coupal L. Bayesian estimation of disease prevalence and the parameters of diagnostic tests in the absence of a gold standard. Am J Epidemiol 1995; 141:263-72.
15. Dendukuri N, Joseph L. Bayesian approaches to modeling the conditional dependence between multiple diagnostic tests. Biometrics 2001; 57:158-67.
16. Lunn D, Spiegelhalter D, Thomas A, Best N. The BUGS project: evolution, critique and future directions. Stat Med 2009; 28: 3049-67.
17. Chu H, Chen S, Louis TA. Random effects models in a meta-analysis of the accuracy of two diagnostic tests without a gold standard. J Am Stat Assoc 2009; 104:512-23.
18. Spiegelhalter D, Abrams K, Myles J. Bayesian approaches to clinical trials and health-care evaluation. West Sussex, United Kingdom: Wiley, 2004.
19. Suputtamongkol Y, Niwattayakul K, Suttinont C, et al. An open, randomized, controlled trial of penicillin, doxycycline, and cefotaxime for patients with severe leptospirosis. Clin Infect Dis 2004; 39:1417-24.
20. Moore CE, Sengduangphachanh A, Thaojaikong T, et al. Enhanced determination of Streptococcus pneumoniae serotypes associated with invasive disease in Laos by using a real-time polymerase chain reaction serotyping assay with cerebrospinal fluid. Am J Trop Med Hyg 2010; 83:451-7.
21. Faine S. Guidelines for the control of leptospirosis. Geneva: WHO offset publication no 67. 1982.
22. Cumberland P, Everard CO, Levett PN. Assessment of the efficacy of an IgM-ELISA and microscopic agglutination test (MAT) in the diagnosis of acute leptospirosis. Am J Trop Med Hyg 1999; 61:731-4.
23. Ahmed A, Engelberts MF, Boer KR, Ahmed N, Hartskeerl RA. Development and validation of a real-time PCR for detection of pathogenic Leptospira species in clinical materials. PLoS One 2009; 4:e7093.
24. Banoo S, Bell D, Bossuyt P, et al. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol 2006; 4:S20-32.
25. Bernatsky S, Lix L, Hanly JG, et al. Surveillance of systemic autoimmune rheumatic diseases using administrative data. Rheumatol Int 2011; 31:549-54.
26. Wagenaar JF, Falke TH, Nam NV, et al. Rapid serological assays for leptospirosis are of limited value in southern Vietnam. Ann Trop Med Parasitol 2004; 98:843-50.
27. Sehgal SC, Vijayachari P, Sugunan AP, Umapathi T. Field application of Lepto lateral flow for rapid diagnosis of leptospirosis. J Med Microbiol 2003; 52:897-901.
28. Smits HL, Chee HD, Eapen CK, et al. Latex based, rapid and easy assay for human leptospirosis in a single test format. Trop Med Int Health 2001; 6:114-8.
29. Obregon AM, Fernandez C, Rodriguez I, Balbis Y, Martinez B, Rodriguez J. Latex agglutination system for the rapid diagnosis of leptospirosis in Cuba. Rev Panam Salud Publica 2004; 16:259-65.
30. Bajani MD, Ashford DA, Bragg SL, et al. Evaluation of four commercially available rapid serologic tests for diagnosis of leptospirosis. J Clin Microbiol 2003; 41:803-9.