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.

High-Risk Human Papillomavirus Detection in Urine Samples From a Referral Population With Cervical Biopsy-Proven High-Grade Lesions.

Unlabelled: The aim of the study was to evaluate the performance of the HPV-HR test to detect high-risk human papillomavirus (HPV) in urine samples in comparison with a commercial molecular HPV test.

Materials And Methods: This is a prospective study, in which 350 patients diagnosed previously with cervical intraepithelial neoplasia (CIN) grade 2 or higher were enrolled. Urine and cervical specimens were collected.

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.

Performance and Diagnostic Accuracy of a Urine-Based Human Papillomavirus Assay in a Referral Population.

Human papillomavirus (HPV) testing from clinician-collected cervical and self-collected cervico-vaginal samples is more sensitive for detecting CIN2/CIN3 than cytology-based screening, stimulating interest in HPV testing from urine. The objective was to determine the performance of the Trovagene HPV test for the detection of CIN2 from urine and PreservCyt cervical samples. Women referred for colposcopy at St Mary's Hospital (London, United Kingdom), following abnormal cytology, were recruited to this diagnostic accuracy study by convenience sampling (September 2011 to April 2013).

Human papillomavirus oncogenic mRNA testing for cervical cancer screening: baseline and longitudinal results from the CLEAR study.

Objectives: This study determined the longitudinal clinical performance of a high-risk human papillomavirus (HR-HPV) E6/E7 RNA assay (Aptima HPV [AHPV]; Hologic, San Diego, CA) compared with an HR-HPV DNA assay (Hybrid Capture 2 [HC2]; Qiagen, Gaithersburg, MD) as an adjunctive method for cervical cancer screening.

Methods: Women 30 years or older with a negative result for intraepithelial lesions or malignancy cytology (n = 10,860) positive by AHPV and/or HC2 assays and randomly selected women negative by both assays were referred to colposcopy at baseline. Women without baseline cervical intraepithelial neoplasia (CIN) grade 2 or higher (CIN2+) continued into the 3-year follow-up.

The reliability of high-risk human papillomavirus detection by Aptima HPV assay in women with ASC-US cytology.

Background: The Aptima HPV assay (AHPV) for high-risk human papillomavirus (hrHPV), and the Aptima HPV 16 18/45 Genotype assay (AHPV GT) for HPV16 and for HPV18 and/or HPV45 (HPV18/45) genotypes are approved for cervical cancer screening by the U.S. Food and Drug Administration.

Comparison of human papillomavirus detection by Aptima HPV and cobas HPV tests in a population of women referred for colposcopy following detection of atypical squamous cells of undetermined significance by Pap cytology.

Few studies have compared the cobas HPV test to the Aptima HPV assay (AHPV) and the Aptima HPV 16 18/45 genotype assay (AHPV GT) for high-risk human papillomavirus (hrHPV) detection, clinical performance in detecting cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+) diagnoses, and risk stratification by partial HPV genotyping. The cobas HPV test is a DNA test that separately and concurrently detects HPV16, HPV18, and a pool of 12 other hrHPV types. AHPV is an RNA test for a pool of 14 hrHPV genotypes, and AHPV GT is an RNA test run on AHPV-positive results to detect HPV16 separately from HPV18 and HPV45, which are detected together.

Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer: results from the CLEAR HPV study.

Objectives: The Aptima human papillomavirus (HPV) 16 18/45 Genotype (GT) assay (AHPV-GT) is a qualitative E6/ E7 oncogene messenger RNA test that detects HPV 16 and a pool of HPV 18 and 45. The CLEAR (Clinical Evaluation of APTIMA mRNA) study was the pivotal, prospective, multicenter US clinical study to validate the Aptima HPV (AHPV) assays.

Methods: In this analysis, we evaluated the clinical performance of AHPV and AHPV-GT assays for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2 +) and grade 3 (CIN3) or adenocarcinoma in situ in 912 women with atypical squamous cells of undetermined significance (ASC-US) Papanicolaou result.

Evaluation of a new APTIMA specimen collection and transportation kit for high-risk human papillomavirus E6/E7 messenger RNA in cervical and vaginal samples.

Background: An APTIMA specimen collection and transportation (SCT) kit was developed by Hologic/Gen-Probe.

Objectives: To compare cervical SCT samples to PreservCyt and SurePath samples and self-collected vaginal samples to physician-collected vaginal and cervical SCT samples. To determine ease and comfort of self-collection with the kit.

APTIMA HPV assay performance in women with atypical squamous cells of undetermined significance cytology results.

Objective: The objective of the study was to determine the sensitivity and specificity of the APTIMA human papillomavirus (AHPV) assay for high-grade cervical intraepithelial neoplasia (CIN) in women 21 years old and older with atypical squamous cells of undetermined significance (ASC-US) cytology.

Study Design: Women 21 years old and older with ASC-US cytology had colposcopy/biopsy and molecular human papillomavirus testing. Performance of the AHPV and Hybrid Capture 2 assays was compared with a clinical diagnosis of CIN grade 2, CIN grade 3, or adenocarcinoma in situ (CIN2 or greater).

Clinical performance of the APTIMA HPV Assay for the detection of high-risk HPV and high-grade cervical lesions.

Background: Human papillomavirus (HPV) DNA testing is widely used in conjunction with Papanicolaou (Pap) testing in cervical cancer screening programs to improve the detection of high-grade lesions. While HPV DNA test sensitivity is good, an improvement in specificity is desired. Detection of HPV mRNA may improve specificity.

Efficiency of the APTIMA HPV Assay for detection of HPV RNA and DNA targets.

Background: The APTIMA HPV Assay (AHPV) is designed to detect HPV E6/E7 mRNA from 14 high-risk types in Cytyc PreservCyt liquid-based cytology specimens.

Objectives: To compare AHPV analytical sensitivity for RNA and DNA; to compare the sensitivity of AHPV and Hybrid Capture 2 (HC2) assays for HPV DNA detection; to compare assay performance with and without sample denaturation; to compare assay results with cytology.

Study Design: Analytical sensitivity of AHPV for detecting E6/E7 RNA was assessed by spiking samples with various quantities of HPV 16 E6/E7 in vitro RNA transcript or HPV 16-positive SiHa cells.

Analytical characterization of the APTIMA HPV Assay.

Background: Human papillomavirus (HPV) testing has improved the sensitivity for the detection of cervical pre-cancer and cancer as compared to Pap testing. Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA HPV Assay however, detects HPV E6/E7 mRNA from 14 high-risk types of HPV: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68.

Detection of HIV-1 in alternative specimen types using the APTIMA HIV-1 RNA Qualitative Assay.

Peripheral blood mononuclear cells (PBMCs), saliva, seminal plasma, and dried blood spots were evaluated as specimen types for the APTIMA HIV-1 RNA Qualitative Assay (APTIMA HIV-1 Assay), which employs a target capture step to recover HIV-1-specific sequences from complex specimen types. Analytical sensitivity studies were carried out using samples that were either diluted or eluted with a buffered detergent and spiked with different concentrations of HIV-1 ranging from 1 to 10,000 copies/mL. PBMC samples spiked with HIV-1 had comparable analytical sensitivity to HIV-1 spiked plasma with a 95% limit of detection of 13.

Incidence of transaminitis among HIV-infected patients with occult hepatitis B.

Background: The clinical significance of occult hepatitis B virus (HBV) infection, defined as the presence of HBV DNA in individuals with HBV core antibodies (anti-HBc) in the absence of HBV surface antigen (HBsAg), is unclear in HIV-infected patients. This information is needed to determine the importance of detecting and treating occult HBV in this population.

Objective: To determine if HIV-infected patients with occult HBV infection have an increased incidence of transaminitis.

The course of hepatitis C viraemia in transfusion recipients prior to availability of antiviral therapy.

Knowing the likely distribution of intervals from hepatitis C infection to first RNA-negativity is important in deciding about therapeutic intervention. Prospectively collected sera and data from the Transfusion-transmitted Viruses Study (1974-1980) provide specific dates of infection and pattern of alanine aminotransferase (ALT) elevations. We examined frequency, timing and correlates of spontaneous resolution for 94 acutely infected transfusion recipients followed for a median of 9.

A cross-sectional study of a prototype carcinogenic human papillomavirus E6/E7 messenger RNA assay for detection of cervical precancer and cancer.

Purpose: To evaluate carcinogenic human papillomavirus (HPV) mRNA for E6 and E7 mRNA detection on clinical specimens to identify women with cervical precancer and cancer.

Experimental Design: We evaluated a prototype assay that collectively detects oncogenes E6/E7 mRNA for 14 carcinogenic HPV genotypes on a sample of liquid cytology specimens (n=531), masked to clinical data and to the presence of HPV genotypes detected by PGMY09/11 L1 consensus primer PCR assay.

Results: We found an increasing likelihood of testing positive for carcinogenic HPV E6/E7 mRNA with increasing severity of cytology (P(Trend) < 0.

Prevalence, risk factors, and outcomes for occult hepatitis B virus infection among HIV-infected patients.

Background: Occult hepatitis B virus (HBV) is defined by the presence of HBV DNA in individuals with HBV core antibodies (anti-HBc) but without HBV surface antigen (HBsAg). The prevalence of occult HBV in HIV-infected patients remains controversial, and the risk factors and clinical significance are unknown.

Objectives: To determine the prevalence, risk factors, and clinical significance of occult HBV among HIV-infected patients.

Evaluation of a new molecular assay for detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and hepatitis B virus DNA.

Background: Rapid, sensitive, specific, and cost-effective screening of donated blood to prevent transmission of infectious agents remains challenging. In recent years, incorporation of nucleic acid testing for HIV-1 and HCV RNA improved blood safety by reducing the window period between infection and serologic detection. For HBV infection, this window period with most serologic assays is 50-60 days.

Viral and host factors in early hepatitis C virus infection.

Since 1980, the Transfusion-transmitted Viruses Study (TTVS) (1974-1980) has continued to maintain its computerized database and stored sera to enable ongoing study of new transfusion events since the 1970s. Most recently, we have used this resource to study parameters of acute hepatitis C virus (HCV) infection among 94 donor-recipient pairs in which there was transmission. In addition, frequent recipient observations permitted further characterization of the early phase of the infection's course.

Sensitivity of second-generation enzyme immunoassay for detection of hepatitis C virus infection among oncology patients.

Background: The second-generation hepatitis C virus (HCV) enzyme immunoassay (EIA 2), an antibody-detection test, has high sensitivity and is one of the recommended screening tests for detecting HCV infection in the United States. However, its sensitivity among oncology patients is unknown.

Objective: Assess the EIA 2 sensitivity among a group of oncology patients at a Nebraska clinic where an HCV outbreak occurred during 2000-2001 using nucleic acid testing (NAT) and recombinant immunoblot assay (RIBA) as the gold standards.

Highly sensitive multiplex assay for detection of human immunodeficiency virus type 1 and hepatitis C virus RNA.

Various nucleic acid assays have been developed and implemented for diagnostics and therapeutic monitoring of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) infections. The high-throughput, semiautomated assays described here were developed to provide a method suitable for screening plasma specimens for the presence of HIV-1 and HCV RNAs. Three assays were developed: a multiplex HIV-1/HCV assay for simultaneous detection of HIV-1 and HCV, and discriminatory assays for specific detection of HIV-1 and HCV.

Significant closure of the human immunodeficiency virus type 1 and hepatitis C virus preseroconversion detection windows with a transcription-mediated-amplification-driven assay.

While the present generation of serology-based assays has significantly decreased the number of human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) infections acquired by transfusion, the possibility of infected donations escaping detection still exists. The average seronegative viremic window duration during which immunological assays are unable to detect the virus is estimated to be between 16 and 22 days for HIV-1 and approximately 70 days for HCV. Significant reduction of detection window duration was demonstrated using a nucleic acid amplification assay, the Procleix HIV-1/HCV Assay, which utilizes transcription-mediated amplification technology to simultaneously detect HIV-1 and HCV RNAs.