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MDL provides detection of Neisseria gonorrhoeae by RealTime PCR, one of the most powerful and sensitive gene
analysis techniques available.
Sensitivity and specificity up to 99%.
Test results are typically available within 24-48 hours.
This test has been validated for detection of N. gonorrhoeae
using the OneSwab, UroSwab (males and females), and
ThinPrep.
Epidemiology
Laboratory Diagnosis
Pathogenesis
Clinical Significance
Table 1: Comparison of Multiple Assay Systems for the Detection of Neisseria gonorrhoeae.
Test
Prevalence (%)
Sensitivity (%)
Specificity (%)
PPV (%)
NPV (%)
References
PCR
100
7.8
100
99.4
93.4
100
(17)
Amplicor
2238
5.2
96.3
98.7
80.2
99.8
(18)
Aptima Combo 2
1479
8.6
99.2
98.7
88.1
99.9
(19)
BD Probe Tec
1411
8.1
97.2
99.4
91.6
99.6
(20)
GEN-PROBE
(Pace 2)
1750
8.7
97.1
99.1
90.6
99.8
(21)
Culture
866
4.5
50.0
97.1
40.0
98.0
(22)
Screening
Treatment
Table 3: Current Recommendations from the CDC for adults, adolescents
& children >45 kg: urogenital, rectal infection with N. gonorrhoeae (16).
Recommended Regimens
Ceftriaxone 250 mg IM in a single dose PLUS
Azithromycin 1 g orally in a single dose
OR
Doxycycline 100 mg orally twice a day for 7 days
Alternative Regimens: If ceftriaxone is not an option
Cefixime 400 mg orally in a single dose PLUS
Azithromycin 1 g orally in a single dose
OR
Doxycycline 100 mg orally twice a day for 7 days
REFERENCES:
1. Miller WC, Ford CA, Morris M, et al. 2004. Prevalence of Chlamydia
Infections Among Young Adults in the United States. JAMA 291:22292236.
2. Monif GR, Baker DA. Infectious Diseases in Obstetrics and
Gynecology, Fifth Edition. New York, NY: The Parthenon Publishing
Group; 2004:222-233.
3. Mandell, GL, Bennett JE, Dolin R. Mandell, Douglas, and Bennetts
Principles and Practices of Infectious Diseases, Vol 2. Philadelphia:
Churchhill Livingstone; 2000:2242-2256.
4. Faro S, Soper DE. Infectious Diseases in Women. Philadelphia: W.B.
Saunders Company; 2001:435-450.
5. Girdner JL, Cullen AP, Salama TG, et al. (1998). ASM Meeting.
6. Donders GF, VanGerven V, de Wet HG, et al. 1996. Scan J Infect Dis.
28:559-562.
7. CDC. 2010. Sexually Transmitted Disease Guidelines. MMWR Vol. 59,
no. RR-12.
8. Girdner JL, Cullen AP, Salama TG, et al. 1998. ASM Meeting.
9. Vlaspolder F, Mustaers JA, Blog F, et al. 1993. J Clin Microbiol
31:107-110.
10. Cullen A, He L, Arthur P, et al. 1998. ASM Meeting.
11. Donders GF, VanGerven V, de Wet HG, et al. 1996. Scan J Infect Dis
28:559-562.
12. Johnson RE, Newhall WJ, Papp JR, et al. 2002. Screening
tests to detect Chlamydia trachomatis and Neisseria gonorrhoeae
infections--2002.
13. CDC. 2002. MMWR Recomm Rep 2002 18;51(RR-15):1-38.
14. van Doornum GJ, Schouls LM, Pijl A, et al. 2001. Comparison
between the LCx Probe System and the COBAS AMPLICOR System
for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
Infections in Patients Attending a Clinic for Treatment of Sexually
Transmitted Diseases in Amsterdam, The Netherlands. J Clin Microbiol
39(3):829-835.
15. Palmer HM, Mallinson H, Wood RL, Herring AJ. 2003. Evaluation of
the Specificities of Five DNA Amplification Methods for the Detection of
Neisseria gonorrheae. J Clin Microbiol 41(2):835-837.
16. CDC. 2010. Update to CDCs Sexually Transmitted Diseases Treatment
Guidelines, Oral Cephalosporins No Longer a Recommended
Treatment for Gonococcal Infection. MMWR 61(31):590-594.
17. Gaydos CA, et al. 2003. Performance of the APTIMA Combo 2 assay
for detection of Chlamydia trachomatis and Neisseria gonorrhoeae
in female urine and endocervical swab specimens. J Clin Microbiol
41(1):304-9.
18. Van Der Pol B, et al. 2001. Multicenter evaluation of the BDProbeTec
ET System for detection of Chlamydia trachomatis and Neisseria
gonorrhoeae in urine specimens, female endocervical swabs, and male
urethral swabs. J Clin Microbiol 39(3):1008-16.
19. Crotchfelt KA, et al. 1997. Detection of Neisseria gonorrhoeae and
Chlamydia trachomatis in genitourinary specimens from men and
women by a coamplification PCR assay. J Clin Microbiol 35(6):1536-40.
20. 510(k) Summary, http://www.fda.gov/cdrh/pdf/k974503. pdf. Device
name: Roche Amplicor CT/NG Test For Neisseria gonorrhoeae.
Accessed 06/2007.
21. Vlaspolder F, et al. 1993. Value of a DNA probe assay (Gen-Probe)
compared wh that of culture for diagnosis of gonococcal infection. J Clin
Microbiol 31(1):107-10.
22. Danders GG, et al. 1996. Rapid antigen tests for Neisseria gonorrhoeae
and Chlamydia trachomatis are not accurate for screening women with
disturbed vaginal lactobacillary flora. Scand J Infect Dis 28(6):559-62.