Sexually Transmitted Infections
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Overcoming Barriers of Sexually Transmitted Infections
Chlamydia trachomatis (CT) is the 1st and Neisseria gonorrhoeae (NG) is the 2nd most commonly reported, notifiable disease in the United States. During 2014, a total of
1.4 million CT and 0.3 million NG infections were reported to the CDC from
all 50 states and the District of Columbia.1
CT Infections increased 2.8% overall as compared to 2013
The CDC has recommended annual screening for chlamydia among all women under the age of 25, for men who have sex with men and for men in high prevalence settings, such as correctional facilities.2 However, screening for CT and NG remains under-utilized with only approximately 50% of the recommended population getting testing.3
Vaginal and urine specimens for men are considered the optimal specimen types for CT and NG testing. These specimen types provide the patient with the opportunity to participate in their health care and reduce the requirement of a doctor or clinician for collection.
Your Lab's Molecular Practices
The CDC recommendations for the detection of chlamydia and gonorrhea are well-aligned with most laboratories' molecular practices. Improved assays and no requirement for confirmation will result in higher clinician confidence in Nucleic Acid Amplification Test (NAAT) generated results. Adoption of the recommended sample types for screening should improve clinic flow and adherence to the screening recommendations by making chlamydia/gonorrhea testing a routine part of reproductive and sexual healthcare.4
Dr. Barbara Van Der Pol
Associate Professor of Medicine,
Division of Infectious Diseases,
University of Alabama at Birmingham
Herpes Simplex Virus (HSV)
Herpes simplex virus (HSV) is among the most prevalent sexually transmitted infections. Most genital Herpes infections in the United States are caused by HSV-2; however, genital HSV-1 infections are increasing among college students and other populations. 1
The incidence of genital Herpes simplex continues to rise, increasing the testing burden on the laboratory. Cell culture and PCR are the preferred HSV tests for persons who seek medical treatment for genital ulcers or other mucocutaneous lesions. 2
Initial visits to physicians' offices in the US 1966–20131
A patient's prognosis and the type of counseling needed depend on the type of genital Herpes (HSV-1 or HSV-2) causing the infection; therefore, the clinical diagnosis of genital Herpes should be confirmed by type-specific laboratory testing.2
Nucleic Acid Amplification Tests such as PCR provide the high sensitivity and specificity required for STI testing with fully automated systems that deliver quick turnaround time.
1. Sexually Transmitted Disease Surveillance 2014, CDC Division of STD Prevention, November 2015
2. Sexually Transmitted Diseases Treatment Guidelines, MMWR, Recommendations and Reports / Vol. 64 / No. 3 June 5, 2015
3. The State of Health Care Quality 2015, HEDIS Measure of Care
4. Advance for Administrators of the Laboratory, April 2015, Vol 24, No. 4
Reducing the Burden of Testing for Sexually Transmitted Infections
cobas® CT/NG v2.0 Test
The cobas® CT/NG v2.0 Test supports CDC recommendations for a Nucleic Acid Amplification Test (NAAT) that is cleared by the Food and Drug Administration (FDA) for both asymptomatic and symptomatic populations. 1
High sensitivity and specificity is achieved via the Dual Primer/Probe Design:
- CT Target: Cryptic plasmid DNA, the CT genomic ompA gene DNA
- NG Target: DR9 A & B, no cross reactivity with commensal Neisseria or other bacterial species
- IC Target: Two individual IC plasmids provide consistent signal with high target input
Performance data for the cobas® CT/NG v2.0 Test can be found in Performance.
For the detection of these genital tract infections, optimal specimen types for NAATs are vaginal swabs from women and first catch urine from men. The cobas CT/NG v2.0 Test is cleared for the following specimen types:
Patient-Collected in a
- Female and male urine
cobas® HSV 1 and 2 Test
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated FDA-cleared test for the direct detection and differentiation of Herpes simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected external anogenital lesion specimens from symptomatic male and female patients. The cobas® HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
Anogenital lesion swab specimens for cobas® HSV 1 and 2 testing are collected with the MSwab Collection, Transport and Preservation Kit.
- Primary specimens are loaded directly on the cobas® 4800 System for testing; no manual pipetting required.
- Specimens collected with the MSwab kit are suitable for bacterial culture of gram positive aerobic and facultative anaerobic organisms, virus culture of HSV 1 and HSV 2, and nucleic acids detection of bacteria and viruses.*
- Mixed run capabilities: cobas® HSV 1 and 2 testing can be performed with the cobas® CDiff and cobas® MRSA tests on the cobas® 4800 system.
Only tests with AmpErase enzyme and the internal control
to minimize false positives and negative results
Layers of protection provide confidence in your results.
* Refer to the COPAN MSwab Collection, Transport and Preservation System Package Insert for culture processing instructions. To avoid crosscontamination, it is recommended that primary tubes be processed on the cobas 4800 system prior to removing aliquots for culture.
1. Recommendations for the Laboratory-Based Detection of Chlamydia trachomatis and Neisseria gonorrhoeae MMWR; Vol. 63/No. 2, March 14, 2014
cobas® CT/NG v2.0 Test
The cobas® CT/NG v2.0 Test is an automated, in vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in urogenital specimens. The test utilizes the Polymerase Chain Reaction (PCR) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in male and female urine, self-collected vaginal swab specimens (collected in a clinical setting), clinician-collected vaginal swab specimens, and endocervical swab specimens, all collected in cobas® PCR Media, and cervical specimens collected in PreservCyt® solution. This test is intended as an aid in the diagnosis of chlamydial and gonococcal disease in both symptomatic and asymptomatic individuals.
Specimens are collected with the cobas® PCR Female Swab kit, cobas® PCR Urine sample kit, or PreservCyt media and are loaded directly on the cobas ®4800 system.
The cobas® CT/NG v2.0 Test uses multiple detection channels on the cobas® z 480 Analyzer for the detection of CT, NG, with the Internal Control in one reaction.
Dual Probe Design
The CT primers and probes are designed to detect targets in both cryptic plasmid and MOMP genomic DNA. The design of the CT primers and probes enables the detection of all major serovars of CT and the Swedish CT Mutant (nvCT), strains that may harbor deletions in the cryptic plasmid, and strains that do not carry the cryptic plasmid.
The NG target region has 2 highly conserved sequence variations that enable the detection of a combination of both target variations with no-cross reactivity with commensal Neisseria or other bacterial species.
CT: Clinical Performance Compared with Patient Infected Status by Gender and Sample Type, and Symptom Status
NG: Clinical Performance Compared with Patient Infected Status by Gender, Sample Type, and Symptom Status
cobas® HSV 1 and 2 Test
The cobas® HSV 1 and 2 Test on the cobas® 4800 system is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection and differentiation of Herpes Simplex virus 1 and 2 (HSV-1 and HSV-2) DNA in clinician-collected, external anogenital lesion specimens from symptomatic male and female patients. The cobas ®HSV 1 and 2 Test is intended for use as an aid in diagnosis of anogenital HSV-1 and HSV-2 infections in symptomatic patients.
The cobas® HSV 1 and 2 Test uses multiple detection channels on the cobas® z 480 Analyzer for the detection of HSV 1, HSV 2, and the Internal Control in one reaction.
Dual Probe Design
The Master Mix reagent contains primer pairs and probes for five targets: the DNA polymerase region Band Thymidine Kinase region C of HSV-1; the Glycoprotein B 3' end region and Thymidine Kinase region C of HSV-2, and the Internal Control.
The clinical performance of the cobas® HSV 1 and 2 Test was established in the prospective, multi-site, investigation comparing to the combined results of culture and Sanger sequencing as the Reference Method using clinician-collected external anogenital lesion swab specimens from patients with possible HSV infection.
There were a total of 408 specimens from 205 female and 203 male subjects evaluated in the study. There were 243 HSV positive subjects by the Composite Reference method; 84 HSV-1 (51 female, 33 male) and 167 HSV-2 (85 female, 82 male) positive subjects, with 8 (2%) subjects positive for both HSV-1 and HSV-2.
1. cobas® CT/NG v2 Test package insert, 07127553001-04EN, Rev. 4.0
2. cobas® HSV 1 and 2 Test package insert, 06979378001-0lEN, Rev. 1.0
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Updated August 26, 2016