Evaluation of a New Multiplex Real-Time Polymerase Chain Reaction Assay for the Detection of Human Papillomavirus Infections in a Referral Population

Jentschke, Matthias; Soergel, Philipp; Lange, Victoria; Kocjan, Boštjan J.; Doerk, Thilo; Luyten, Alexander; Petry, Karl Ulrich; Poljak, Mario; Hillemanns, Peter

doi:10.1097/igc.0b013e31825529b7

Cited by 11 publications

(4 citation statements)

References 28 publications

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“…From this material, both cytological and hrHPV-testing were performed and used for reference in our study. All samples were tested with the Abbott RealTime High Risk HPV Test (Abbott GmbH & Co. KG, Wiesbaden, Germany), an automated, qualitative multiplex PCR assay for the detection of 14 hr-HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) and simultaneous differentiation of HPV 16 and HPV 18, as previously described [ 18 ]. An example of the amplifications curves can be found in the Supplemental Material .…”

Section: Methodsmentioning

confidence: 99%

CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection

Ertik

Kampers

Hülse

et al. 2021

IJERPH

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High-risk human papillomavirus (hr-HPV) infection of the cervicovaginal tract is known to be the major cause of cervical cancer. Similar to various other countries, Germany introduced an organized combined screening including cytology and HPV testing in 2020. The participation rate was around 70% in the past. Self-testing for hr-HPV infections could be an option to increase the participation rate. Two dry vaginal self-sampling devices and a device for the self-collection of first-void urine were evaluated in combination with a PCR-based hr-HPV test regarding their clinical performance (sensitivity for high-grade cervical intraepithelial neoplasia, CIN 2+). A cervical smear taken by a clinician during colposcopy was used as reference. This open prospective multicenter trial recruited patients referred to the two participating colposcopy clinics (Hannover Medical School and IZD Hannover, Germany) with abnormal results from cervical cancer screening from 05/2020 to 11/2020. All patients received three CE-certified self-sampling devices (FLOQSwabs, COPAN, Italy; Evalyn Brush, Rovers Medical Devices, the Netherlands; Colli-Pee FV-5000, Novosanis, Wijnegem, Belgium) with instructions to read and apply at home in a pre-specified alternating order without medical assistance. HPV testing was performed after adequate preservation and DNA extraction. Histological results from colposcopy or cervical excisional surgery after self-sampling were used as the gold-standard. The data of 65 patients were analyzed. All invasive cancer cases and over 90% of the CIN 3 lesions were found to be hr-HPV positive with all three self-collection devices. All devices were considered easy to use without any difficulties following the written instructions. Hr-HPV testing of self-collected first-void urine and dry vaginal self-samples showed a high sensitivity for CIN 3+ comparable to that of a clinician-taken smear. Self-sampling was well accepted as it is convenient and easy to use.

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Section: Methodsmentioning

confidence: 99%

CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection

Ertik

Kampers

Hülse

et al. 2021

IJERPH

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“…In addition for populations at high risk for HIV infection, it also provides a method to decrease the window between infection and seroconversion, which is a relatively short period when viral loads are highest and transmission (infection of others) is most likely. Other applications could apply to the detection of anti-HPV (subtype 16 and 18) antibodies [29, 30] and HPV subtype-specific DNA [31–33] in oral fluid as a potential indicator for oral cancer. Also, the prospect of a higher complexity device that can combine the detection of antibodies against helmintic Schistosoma species, pathogen-derived NA targets and specific glycosylated-proteinaceous antigens can be explored [34–36].…”

Section: Discussionmentioning

confidence: 99%

Development of a Generic Microfluidic Device for Simultaneous Detection of Antibodies and Nucleic Acids in Oral Fluids

Chen

Abrams

Geva

et al. 2013

BioMed Research International

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A prototype dual-path microfluidic device (Rheonix CARD) capable of performing simultaneously screening (antigen or antibody) and confirmatory (nucleic acid) detection of pathogens is described. The device fully integrates sample processing, antigen or antibody detection, and nucleic acid amplification and detection, demonstrating rapid and inexpensive “sample-to-result” diagnosis with performance comparable to benchtop analysis. For the chip design, a modular approach was followed allowing the optimization of individual steps in the sample processing process. This modular design provides great versatility accommodating different disease targets independently of the production method. In the detection module, a lateral flow (LF) protocol utilizing upconverting phosphor (UCP) reporters was employed. The nucleic acid (NA) module incorporates a generic microtube containing dry reagents. Lateral flow strips and PCR primers determine the target or disease that is diagnosed. Diagnosis of HIV infection was used as a model to investigate the simultaneous detection of both human antibodies against the virus and viral RNA. The serological result is available in less than 30 min, and the confirmation by RNA amplification takes another 60 min. This approach combines a core serological portable diagnostic with a nucleic acid-based confirmatory test.

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“…RealTime is a qualitative multiplex test based on real-time PCR used for the detection of 14 hr-HPV genotypes (16, 18, [20]). …”

Section: Hpv Test Methodsmentioning

confidence: 99%

The Value of Partial HPV Genotyping After Conization of Cervical Dysplasias

Friebe

Klapdor

Hillemanns

et al. 2017

Geburtshilfe Frauenheilkd

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Introduction In this retrospective study partial genotyping of human papilloma viruses (HPV) using the Abbott RealTime HighRisk HPV Test (RealTime) was compared with simple HPV detection (Qiagen Hybrid Capture 2 Test; hc2) for recurrence prediction at the first follow-up examination after conization of cervical intraepithelial neoplasia (CIN). Methods 144 women who had undergone conization for CIN between January 2007 and December 2013 were included. HPV status was determined preoperatively and at first follow-up using hc2 in 103 women and RealTime in 41 women. Recurrent or persistent CIN was assumed when CIN2+ was confirmed histologically or on comparable cytology findings. Results Of the 144 women with complete data 12 (8.3%) had a recurrence after conization. HPV persistence at follow-up correlated significantly with recurrence (hc2: p = 0.003; RealTime: p = 0.003) and both sensitivity and specificity were high (hc2 = 100 and 78.4% respectively; RealTime = 75.0 and 83.9%). Whereas isolated HPV testing had a relatively low positive predictive value for recurrence (hc2 16%; RealTime 54.5%), this rose to 80% with HPV 16 detection at follow-up. Conclusion At follow-up after conization of CIN the combination of high risk HPV detection and partial genotyping of HPV 16 constitutes excellent diagnostic criteria for recurrence/persistence of CIN.

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Evaluation of a New Multiplex Real-Time Polymerase Chain Reaction Assay for the Detection of Human Papillomavirus Infections in a Referral Population

Cited by 11 publications

References 28 publications

CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection

CoCoss-Trial: Concurrent Comparison of Self-Sampling Devices for HPV-Detection

Development of a Generic Microfluidic Device for Simultaneous Detection of Antibodies and Nucleic Acids in Oral Fluids

The Value of Partial HPV Genotyping After Conization of Cervical Dysplasias

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