HPV genotype-specific distribution and attributable risk in cervical intraepithelial neoplasia in a referral population with a history of LSIL.

Background And Objective: CINtec PLUS and cobas HPV tests (Roche) were previously ascertained for triaging an LSIL referral population [1]. As part of this study, genotype-specific distribution and attributable risk of high-risk (HR)-HPV in cervical intraepithelial neoplasia (CIN) were determined.

Methods: Archived cervical specimens in ThinPrep PreservCyt (Hologic Inc) from the LSIL referral population (n= 533) were genotyped using the Anyplex II HPV HR test (Anyplex, Seegene Inc).

Comparison of CINtec PLUS cytology and cobas HPV test for triaging Canadian patients with LSIL cytology referred to colposcopy: A two-year prospective study.

Objectives & Methods: CINtec PLUS and cobas HPV tests were compared for triaging patients referred to colposcopy with a history of LSIL cytology in a 2-year prospective study. Cervical specimens were tested once at enrollment, and test positivity rates determined. Test performance was ascertained with cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and CIN3 or worse (CIN3+) serving as clinical endpoints.

Multicenter Comparison of Nucleic Acid Amplification Tests for the Diagnosis of Rectal and Oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae Infections.

Research using nucleic acid amplification tests (NAATs) have repeatedly found rectal and oropharyngeal infections with Chlamydia trachomatis and Neisseria gonorrhoeae to be common and potentially more difficult to treat than genital infections. Unfortunately, public health and patient care efforts have been hampered by the lack of FDA-cleared NAATs with claims for anorectal or oropharyngeal samples. At the time of the initiation of this study, no commercially available assays had these claims.

Comparison of Alinity m HPV and cobas HPV assays on cervical specimens in diverse storage media.

Objective: To assess the concordance of high-risk HPV (HR-HPV) testing with the Alinity assay on cervical samples collected with diverse collection/storage protocols (ThinPrep, SurePath, Cervicollect) and to assess inter-assay concordance of HR-HPV testing of cervical cell specimens with Alinity m HR HPV assay (Alinity) vs cobas® 4800 HPV assay (cobas).

Methods: Specimens were obtained from 560 women attending a Women's Health clinic. Two specimens were obtained from each woman with combinations of two of the three collection devices and aliquots were tested by the two assays.

Workflow and Throughput of Commercial Assays to Detect Mycoplasma genitalium and Macrolide Resistance-Mediating Mutations.

Aptima Mycoplasma genitalium (MG) required the shortest and STD6 the longest time to detect MG in clinical samples. ResistancePlus MG detected MG and macrolide resistance-mediating mutations simultaneously. Times were influenced by specimen numbers.

Comparison of Assays for the Diagnosis of Mycoplasma genitalium and Macrolide Resistance Mutations in Self-Collected Vaginal Swabs and Urine.

Background: The objective was to compare commercial assays on clinical specimens for Mycoplasma genitalium (MG) detection and macrolide resistance mutation (MRM) frequency.

Methods: Three self-collected vaginal swabs (VS) and a first-void urine (FVU) from 300 consented women were tested by Aptima MG (AMG), ResistancePlus MG (RPMG) and Seeplex STD6 ACE (STD6) for detection of MG. Aptima MG and STD6 MG positives were tested for MRM using MG 23S rRNA polymerase chain reaction with Sanger sequencing (23SMGSS) compared with MRM determination in the RPMG assay.

CINtec PLUS and cobas HPV testing for triaging Canadian women referred to colposcopy with a history of low-grade squamous intraepithelial lesion: Baseline findings.

Objective And Methods: CINtec PLUS and cobas HPV tests were assessed for triaging women referred to colposcopy with a history of LSIL cytology. Both tests were performed at baseline using ThinPrep cervical specimens and biopsy confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) served as the clinical endpoint.

Results: In all ages, (19-76 years, n = 600), 44.

Performance of AmpFire HPV assay on neck cervical lymph node aspirate and oropharyngeal samples.

Early determination of high-risk human papillomaviruses causing oropharyngeal squamous cell carcinomas (OPSCC) may influence treatment. The objectives were to evaluate the performance of a new rapid isothermal nucleic acid amplification point of care HPV test (AmpFire HPV) on fine needle neck aspirates (FNA) of cervical lymph nodes and oropharyngeal swabs and saliva (OPS) which had been previously tested by the cobas HPV assay. The comparison was performed on 56 FNA and 81 OPS.

Mycoplasma genitalium, Chlamydia trachomatis, and Neisseria gonorrhoeae Detected With Aptima Assays Performed on Self-Obtained Vaginal Swabs and Urine Collected at Home and in a Clinic.

Self-obtained vaginal swabs, first-void urine and pooled specimens were collected at home and in a clinic. Percent prevalence and collection site concordance was 30.3 and 100 for Mycoplasma genitalium (74.

Alternate Nucleic Acid Targets Can Be Used To Create a Composite Standard To Evaluate Clinical Performance of Nucleic Acid Amplification Tests.

Evaluating the clinical performance of a new nucleic acid amplification test (NAAT) for , B. Kirkconnell, B. Weinbaum, K.

Treatment of first-void urine with Aptima Transfer Solution increases detection of high-risk HPV E6/E7 mRNA.

Because of its non-invasive nature urine testing may enable increased screening for HPV in women who avoid cervical sampling. Comparisons have shown fewer HPV positives in urine. The objectives were to compare first-void urine (FVU) treated with proteinase K (PK) to untreated FVU and cervical samples collected from women attending a colposcopy clinic using an Aptima HPV mRNA assay, and comparing the HPV rates to cytology and pathology results.

Comparative performance of human papillomavirus messenger RNA versus DNA screening tests at baseline and 48 months in the HPV FOCAL trial.

Background: HPV FOCAL is a randomized trial comparing high-risk HPV [Hybrid Capture 2 (HC2)] vs. liquid-based cytology (LBC) for primary cervical screening.

Objective: The present study objective was to compare Aptima HPV (AHPV) and HC2 assay performance at the intervention arm baseline and 48 mo.

Trichomonas vaginalis Prevalence and Correlates in Women and Men Attending STI Clinics in Western Canada.

Trichomonas vaginalis prevalence (2.8%) in female sexually transmitted infection clinic attendees was within the prevalence of chlamydia (5.8%) and gonorrhea (1.

Detection of cervical precancerous lesions with Aptima HPV assays using SurePath preservative fluid specimens.

SurePath specimens from women referred to colposcopy were treated with Aptima Transfer Solution (ATS) before testing in Aptima HPV (AHPV) and Aptima HPV 16, 18/45 (AHPV-GT) assays. Untreated SurePath specimens were tested with the cobas HPV test. PreservCyt specimens were assessed for cytology and tested with AHPV.

Urinary Meatal Swabbing Detects More Men Infected With Mycoplasma genitalium and Four Other Sexually Transmitted Infections Than First Catch Urine.

Urinary meatal swabs compared with urine showed higher infection rates for Mycoplasma genitalium (15.3% vs 12.6%, P = 0.

Prevalence and antibiotic resistance of among STI clinic attendees in Western Canada: a cross-sectional analysis.

Objectives: To determine the prevalence and correlates of (MG) infection among men and women, determine the prevalence of gene mutations conferring resistance and compare test performance of female specimen types.

Methods: A cross-sectional study was conducted on specimens collected for gonorrhoea (NG, ) and chlamydia (CT, ) among male and female Alberta STI clinic attendees using the transcription-mediated amplification-research use only test. Positive specimens were sequenced for 23SrRNA, and genes.

Mycoplasma genitalium Antibiotic Resistance-Mediating Mutations in Canadian Women With or Without Chlamydia Trachomatis Infection.

Testing remnant Aptima specimens from women infected with Chlamydia trachomatis detected 13.4% (53/396) with Mycoplasma genitalium compared with 5.4% (22/406) in matched C.

Comparison of cobas 4800, m2000, Viper XTR, and Infinity 80 Automated Instruments When Processing Urine Specimens for the Diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae.

Objectives: North American and European advisory groups recommend testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) with nucleic acid amplification tests. Testing is often performed on automated instruments. The objectives of this study were to process urines for the diagnosis of CT and NG and to examine workflow procedures and outcomes.

Aptima HPV Assay versus Hybrid Capture 2 HPV test for primary cervical cancer screening in the HPV FOCAL trial.

Background: Cervical cancer screening programs are switching from Pap screening to high-risk HPV testing.

Objectives: To compare the Aptima HPV Assay (AHPV) with the Hybrid Capture 2 High-Risk HPV DNA Test (HC2) for primary cervical screening.

Study Design: HPV FOCAL is a randomized trial comparing HC2 to liquid-based cytology (LBC) for screening women aged 25-65.

Comparison of Workflow, Maintenance, and Consumables in the GeneXpert Infinity 80 and Panther Instruments While Testing for Chlamydia trachomatis and Neisseria gonorrhoeae.

Background: The 2015 Sexually Transmitted Diseases Treatment Guidelines from the Centers for Disease Control and Prevention recommend testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests, and prompt treatment of infected persons on site under direct observation. Faster time to results may enable treatment and management outcomes.

Methods: Workflow parameters for processing 1, 10, 48, 96, and 192 tests were determined in the GeneXpert Infinity 80 (Cepheid) and Panther (Hologic) instruments.