A laboratory-based evaluation of four rapid point-of-care tests for syphilis

PLoS ONE

Volumn 9, Issue 3, 2014, Pages

  Causer, Louise M ^a   Kaldor, John M ^a   Fairley, Christopher K ^b   Donovan, Basil ^a   Karapanagiotidis, Theo ^c   Leslie, David E ^c   Robertson, Peter W ^d   McNulty, Anna M ^e   Anderson, David ^f   Wand, Handan ^a   Conway, Damian P ^a   Denham, Ian ^g   Ryan, Claire ^f   Guy, Rebecca J ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c VICTORIAN INFECTIOUS DISEASES REFERENCE LABORATORY   (Australia)

^d PRINCE OF WALES HOSPITAL   (Australia)

^e Sydney Sexual Health Centre   (Australia)

^f BURNET INSTITUTE   (Australia)

^g MELBOURNE SEXUAL HEALTH CENTRE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; AGED; ANTIBODY TITER; ARTICLE; AUSTRALIA; CONTROLLED STUDY; DISEASE CONTROL; FEMALE; FLUORESCENT TREPONEMA ANTIBODY TEST; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; IMMUNOASSAY; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; POINT OF CARE TESTING; SENSITIVITY AND SPECIFICITY; SEROLOGY; SYPHILIS; TASK PERFORMANCE; VERY ELDERLY; ADOLESCENT; DIAGNOSTIC KIT; EVALUATION STUDY; HOSPITAL INFORMATION SYSTEM; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MIDDLE AGED; MIXED INFECTION; PROCEDURES; RISK FACTOR; STANDARDS; SYPHILIS SEROLOGY; YOUNG ADULT;

DIAGNOSTIC KIT;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; AUSTRALIA; COINFECTION; FEMALE; HIV SEROPOSITIVITY; HUMANS; MALE; MIDDLE AGED; POINT-OF-CARE SYSTEMS; REAGENT KITS, DIAGNOSTIC; RISK FACTORS; SENSITIVITY AND SPECIFICITY; SYPHILIS; SYPHILIS SERODIAGNOSIS; YOUNG ADULT;

EID: 84897484571     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0091504     Document Type: Article

References (40)

1. Donovan B, Dayan L (2010) Syphilis. In: Warrell DA, Cox TM, Firth JD, editors. Oxford textbook of medicine. Oxford: Oxford University Press. pp. 885-896.
2. Watson-Jones D, Gumodoka B, Weiss H, Changalucha J, Todd J, et al. (2002) Syphilis in pregnancy in Tanzania. II. The effectiveness of antenatal syphilis screening and single-dose benzathine penicillin treatment for the prevention of adverse pregnancy outcomes. J Infect Dis 186: 948-957.
3. Buchacz K, Patel P, Taylor M, Kerndt PR, Byers RH, et al. (2004) Syphilis increases HIV viral load and decreases CD4 cell counts in HIV-infected patients with new syphilis infections. AIDS 18: 2075-2079. (Pubitemid 39463361)
4. Wasserheit JN (1992) Epidemiological synergy. Interrelationships between human immunodeficiency virus infection and other sexually transmitted diseases. Sexually Transmitted Diseases 19: 61-77.
5. Centers for Disease Control and Prevention (2010) Sexually Transmitted Diseases Treatment Guidelines, 2010. MMWR 59: 1-109.
6. Sexual Health Society of Victoria (2008) National Management Guidelines for Sexually Transmissible Infections, 7th Edition. 7th ed. Victoria, Australia: Sexual Health Society of Victoria. pp. 1-142.
7. STIs in Gay Men Action Group (STIGMA) (2010) Sexually transmitted infection testing guidelines for men who have sex with men. Available: http://stigma.net.au/resources/STIGMA-MSM-Testing-Guidelines-2010.pdf. Accessed 2013 June 4.
8. Peeling RW, Holmes KK, Mabey D, Ronald A (2006) Rapid tests for sexually transmitted infections (STIs): the way forward. Sex Transm Infect 82 Suppl 5: v1-6. (Pubitemid 46293817)
9. Vickerman P, Peeling RW, Terris-Prestholt F, Changalucha J, Mabey D, et al. (2006) Modelling the cost-effectiveness of introducing rapid syphilis tests into an antenatal syphilis screening programme in Mwanza, Tanzania. Sex Transm Infect 82 Suppl 5: v38-43. (Pubitemid 46293825)
10. World Health Organisation (2007) The Global Elimination of Syphilis: Rationale and Strategy for Action. Geneva, Switzerland: WHO.
11. Mabey DC, Sollis KA, Kelly HA, Benzaken AS, Bitarakwate E, et al. (2012) Point-of-care tests to strengthen health systems and save newborn lives: the case of syphilis. PLoS Med 9: e1001233.
12. Mabey D, Peeling RW, Ballard R, Benzaken AS, Galban E, et al. (2006) Prospective, multi-centre clinic-based evaluation of four rapid diagnostic tests for syphilis. Sex Transm Infect 82 Suppl 5: v13-16. (Pubitemid 46293819)
13. Siedner M, Zapitz V, Ishida M, De La Roca R, Klausner JD (2004) Performance of rapid syphilis tests in venous and fingerstick whole blood specimens. Sexually Transmitted Diseases 31: 557-560. (Pubitemid 39122139)
14. Herring A, Ballard R, Mabey D, Peeling RW (2006) Evaluation of rapid diagnostic tests: syphilis. Nat Rev Microbiol 4: S33-40. (Pubitemid 44773208)
15. Tucker JD, Bu J, Brown LB, Yin YP, Chen XS, et al. (2010) Accelerating worldwide syphilis screening through rapid testing: a systematic review. Lancet Infect Dis 10: 381-386.
16. Jafari Y, Peeling RW, Shivkumar S, Claessens C, Joseph L, et al. (2013) Are Treponema pallidum Specific Rapid and Point-of-Care Tests for Syphilis Accurate Enough for Screening in Resource Limited Settings? Evidence from a Meta-Analysis. PLoS One 8: e54695.
17. Blandford JM, Gift TL, Vasaikar S, Mwesigwa-Kayongo D, Dlali P, et al. (2007) Cost-effectiveness of on-site antenatal screening to prevent congenital syphilis in rural eastern Cape Province, Republic of South Africa. Sexually Transmitted Diseases 34: S61-66. (Pubitemid 47012322)
18. Rydzak CE, Goldie SJ (2008) Cost-effectiveness of rapid point-of-care prenatal syphilis screening in sub-Saharan Africa. Sexually Transmitted Diseases 35: 775-784.
19. Bronzan RN, Mwesigwa-Kayongo DC, Narkunas D, Schmid GP, Neilsen GA, et al. (2007) On-site rapid antenatal syphilis screening with an immunochromatographic strip improves case detection and treatment in rural South African clinics. Sexually Transmitted Diseases 34: S55-60. (Pubitemid 47012321)
20. Read PJ, Donovan B (2012) Clinical aspects of adult syphilis. Intern Med J 42: 614-620.
21. Jin F, Prestage GP, Zablotska I, Rawstorne P, Kippax SC, et al. (2007) High rates of sexually transmitted infections in HIV positive homosexual men: data from two community based cohorts. Sex Transm Infect 83: 397-399. (Pubitemid 47242490)
22. Cole M, Perry K (2004) Ten Syphilis EIAs. Medicines and Healthcare products Regulatory Agency (MHRA), NHS, UK: p 1-47.
23. Burgess C, Perry K, Newham J, Kitchen A (2008) Evaluation of Abbott Architect Syphilis TP Assay Product Code 8D06. NHS Blood and Transport, Health Protection Agency, UK: p 1-11.
24. Hunter MG, Robertson PW, Post JJ (2013) Significance of isolated reactive treponemal chemiluminescence immunoassay results. J Infect Dis 207: 1416-1423.
25. Lowry R (2012) VassarStats: Website for Statistical Computation. Available: http://vassarstats.net/clin1.html. Accessed 2012 August 10.
26. Mamoojee Y, Tan G, Gittins S, Sarfo S, Stephenson L, et al. (2012) Diagnosis of treponemal co-infection in HIV-infected West Africans. Trop Med Int Health 17: 1521-1526.
27. Lien TX, Tien NT, Chanpong GF, Cuc CT, Yen VT, et al. (2000) Evaluation of rapid diagnostic tests for the detection of human immunodeficiency virus types 1 and 2, hepatitis B surface antigen, and syphilis in Ho Chi Minh City, Vietnam. Am J Trop Med Hyg 62: 301-309. (Pubitemid 30257594)
28. Herring AJ, Ballard RC, Pope V, Adegbola RA, Changalucha J, et al. (2006) A multi-centre evaluation of nine rapid, point-of-care syphilis tests using archived sera. Sex Transm Infect 82 Suppl 5: v7-12.
29. Montoya PJ, Lukehart SA, Brentlinger PE, Blanco AJ, Floriano F, et al. (2006) Comparison of the diagnostic accuracy of a rapid immunochromatographic test and the rapid plasma reagin test for antenatal syphilis screening in Mozambique. Bull World Health Organ 84: 97-104. (Pubitemid 43275767)
30. Tinajeros F, Grossman D, Richmond K, Steele M, Garcia SG, et al. (2006) Diagnostic accuracy of a point-of-care syphilis test when used among pregnant women in Bolivia. Sex Transm Infect 82 Suppl 5: v17-21. (Pubitemid 46293820)
31. West B, Walraven G, Morison L, Brouwers J, Bailey R (2002) Performance of the rapid plasma reagin and the rapid syphilis screening tests in the diagnosis of syphilis in field conditions in rural Africa. Sex Transm Infect 78: 282-285.
32. Hernandez-Trejo M, Hernandez-Prado B, Uribe-Salas F, Juarez-Figueroa L, Conde-Gonzalez CJ (2006) [Maternal and congenital syphilis in two Mexican hospitals: evaluation of a rapid diagnostic test]. Rev Invest Clin 58: 119-125.
33. Nessa K, Alam A, Chawdhury FA, Huq M, Nahar S, et al (2008) Field evaluation of simple rapid tests in the diagnosis of syphilis. Int J STD AIDS 19: 316-320. (Pubitemid 351748272)
34. Yin YP, Chen XS, Wei WH, Gong KL, Cao WL, et al. (2013) A Dual Point-of-Care Test Shows Good Performance in Simultaneously Detecting Nontreponemal and Treponemal Antibodies in Patients With Syphilis: A Multisite Evaluation Study in China. Clin Infect Dis 56: 659-665.
35. Diaz T, Almeida MG, Georg I, Maia SC, De Souza RV, et al. (2004) Evaluation of the Determine Rapid Syphilis TP assay using sera. Clin Diagn Lab Immunol 11: 98-101. (Pubitemid 38090659)
36. Lynn WA, Lightman S (2004) Syphilis and HIV: a dangerous combination. Lancet Infect Dis 4: 456-466. (Pubitemid 38844130)
37. Guy RJ, Leslie DE, Simpson K, Hatch B, Leydon J, et al. (2005) Sustained increase in infectious syphilis notifications in Victoria. Med J Aust 183: 218. (Pubitemid 41150335)
38. Jin F, Prestage GP, Kippax SC, Pell CM, Donovan BJ, et al. (2005) Epidemic syphilis among homosexually active men in Sydney. Med J Aust 183: 179-183. (Pubitemid 41150322)
39. Peterman TA, Heffelfinger JD, Swint EB, Groseclose SL (2005) The changing epidemiology of syphilis. Sexually Transmitted Diseases 32: S4-10.
40. Castro AR, Esfandiari J, Kumar S, Ashton M, Kikkert SE, et al. (2010) Novel point-of-care test for simultaneous detection of nontreponemal and treponemal antibodies in patients with syphilis. J Clin Microbiol 48: 4615-4619.