Pitfalls of internet-accessible diagnostic tests: Inadequate performance of a CE-marked Chlamydia test for home use

Sexually Transmitted Infections

Volumn 85, Issue 3, 2009, Pages 187-189

  Michel, C E C ^a   Saison, F G ^b   Joshi, H ^a   Mahilum Tapay, L M ^c   Lee, H H ^a  

^a UNIVERSITY OF CAMBRIDGE   (United Kingdom)

^b Western Visayas Medical Center   (Philippines)

^c Diagnostics for the Real World Europe Ltd   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADULT; ARTICLE; CHLAMYDIA TEST; CHLAMYDIA TRACHOMATIS; CHLAMYDIASIS; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; FALSE POSITIVE RESULT; FEMALE; HOME DIAGNOSTIC TEST; HUMAN; INTERMETHOD COMPARISON; INTERNET; MAJOR CLINICAL STUDY; NUCLEIC ACID AMPLIFICATION; PREVALENCE; PRIORITY JOURNAL; VAGINA SMEAR;

ADULT; CHLAMYDIA INFECTIONS; CHLAMYDIA TRACHOMATIS; DIAGNOSTIC TESTS, ROUTINE; FALSE NEGATIVE REACTIONS; FALSE POSITIVE REACTIONS; FEMALE; HUMANS; INTERNET; NUCLEIC ACID AMPLIFICATION TECHNIQUES; PHILIPPINES; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY; VAGINAL SMEARS;

EID: 66449093132     PISSN: 13684973     EISSN: 14723263     Source Type: Journal    
DOI: 10.1136/sti.2008.035055     Document Type: Article

References (16)

1. Pate MS, Dixon PB, Hardy K, et al. Evaluation of the Biostar Chlamydia OIA Assay with specimens from women attending a sexually-transmitted disease clinic. J Clin Microbiol 1998;36:2183-2186 (Pubitemid 28324062)
2. Blanding J, Hirsch L, Stranton N, et al. Comparison of the Clearview Chlamydia, the PACE 2 Assay, and cell culture for the detection of Chlamydia trachomatis in cervical specimens in a low-prevalence population. J Clin Microbiol 1993;31:1622-1625 (Pubitemid 23164434)
3. Yin Y-P, Peeling RW, Chen X-S, et al. Clinic-based evaluation of Clearview Chlamydia MF for detection of Chlamydia trachomatis in vaginal and cervical specimens from women at high risk in China. Sex Transm Infect 2006;82:33-37 (Pubitemid 46293824)
4. Mahilum-Tapay LM, Laitila V, Wawrzyniak JJ, et al. New point of care Chlamydia Rapid Test - bridging the gap between diagnosis and treatment: performance evaluation study. BMJ 2007;335:1190-1194 (Pubitemid 350273302)
5. Zonda Incorporated. Technical Alert HandiLab-C. http://www.zondaincusa. com/ documents/ALERT!-Chlamydia-testing.pdf (accessed 21 Apr 2009).
6. Zonda Incorporated. Comparison of the HandiLab-C Chlamydia trachomatis rapid test device with PCR Chlamydia testing (Chly01-Hun). http://www. zondaincusa.com/ documents/Hungarian%20PCR-HandiLab2.pdf (accessed 21 Apr 2009).
7. MHRA. Notified bodies. http://www.mhra.gov.uk/howweregulate/devices/ notifiedbodies/index.htm (accessed 21 Apr 2009).
8. Moi H, Hartgill U, Handilab C. Chlamydia Hometest: doesn't deliver what it promises [abstract]. Int J STD AIDS 2007;18(1 Suppl):20-21
9. Politiken DK. Klamydiatest kaldes tilbage efter kritik - Tvivl om effekten af hjemmeklamydiatest får firmaet bag til at trække den midlertidigt tilbage. http://politiken.dk/indland/article174995.ece (accessed 21 Apr 2009).
10. Sexsygdom.dk. Kritik af gør-det-selv klamydiatest til kvinder-En ny gør-det-selv klamydiatest giver i flere tilfælde et falsk resultat. Ekspert på området efterlyser dokumentation for, at testen virker. http://www.sexogsamfund.dk/default.aspx?ID= 4003 (accessed 21 Apr 2009).
11. US Food and Drug Administration. 510(k) Substantial equivalence determination - Decision Summary, 510(k) No K080739, Type of Test: Nucleic Acid Amplification, Applicant: Abbott Molecular Inc., Proprietary and Established Names: Abbott RealTime CT/NG, Analalyte: Chlamydia trachomatis and Neisseria gonorrhoeae (accessed 21 Apr 2009).Accessed Apr 2009.
12. Schachter J, McCormack WM, Chernesky MA, et al. Vaginal swabs are appropriate specimens for diagnosis of genital tract infection with Chlamydia trachomatis. J Clin Microbiol 2003 August;41:3784-3789 (Pubitemid 36994716)
13. Michel CE, Sonnex C, Carne CA, et al. Chlamydia trachomatis load at matched anatomic sites: implications for screening strategies. J Clin Microbiol 2007;45:1395-1402 (Pubitemid 46762389)
14. Pickett MA, Everson JS, Pead PJ, et al. The plasmids of Chlamydia trachomatis and Chlamydophila pneumoniae (N16): accurate determination of copy number and theparadoxical effect of plasmid-curing agents. Microbiology 2005;151:893-903.
15. Saison FG, Mahilum-Tapay L, Michel C-EE, et al. Prevalence of Chlamydia trachomatis infection among low- and high-risk Filipino women and performance of Chlamydia rapid tests in resource-limited settings. J Clin Microbiol 2007;45:4011-4017 (Pubitemid 350274885)
16. Gaydos CA, Dwyer K, Barnes M, et al. Internet based screening for Chlamydia trachomatis to reach non-clinic populations with mailed self-administered vaginal swabs. Sex Transm Dis 2006;33:451-457 (Pubitemid 43964756)