A Head-to-Head Analytical Comparison of Cobas 4800 HPV, PapilloCheck HPV Screening, and LMNX Genotyping Kit HPV GP for Detection of Human Papillomavirus DNA in Cervical and Cervicovaginal Swabs

Jaworek, Hana; Koudeláková, Vladimíra; Drábek, Jir̆ı́; Vrbková, Jana; Zbořilová, B; Oborná, I; Březinová, Jana; Marek, R; Huml, K; Vanek, Peter; Hajdúch, Marián

doi:10.1016/j.jmoldx.2018.07.004

Cited by 11 publications

(12 citation statements)

References 33 publications

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“…Cervical swabs and semen samples were tested for HPV DNA using the cobas ® 4800 HPV Test (Roche Diagnostics GmBH, Mannheim, Germany) according to the manufacturer’s recommendations for cervical sample management [ 17 ]. After analysis, DNA extracted using cobas × 480 was used for HPV DNA detection and genotyping using the PapilloCheck ® HPV-Screening kit (Greiner Bio-One, Frickenhausen, Germany) [ 18 ] as described previously [ 19 ]. DNA from penile swabs was isolated using the QIAamp ® DNA detection by Micro kit (Qiagen, Hilden, Germany) and then tested for HPV PapilloCheck ® HPV-Screening kit [ 18 ].…”

Section: Methodsmentioning

confidence: 99%

Impact of human papillomavirus infection on semen parameters and reproductive outcomes

Jaworek

Koudeláková

Oborná³

et al. 2021

Reprod Biol Endocrinol

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Background Human papillomavirus (HPV) has been shown to adversely affect human reproduction. We aimed to evaluate the prevalence of human papillomavirus (HPV) infection in men and its correlation with semen parameters and reproductive outcomes. Methods Semen samples and penile swabs were collected from potential sperm donors (SD, n = 97) and male partners of infertile couples (IM, n = 328). The presence of HPV DNA in semen samples and penile swabs was analyzed. Associations between hrHPV positive status and fertility outcomes as well as socio-behavioral and health characteristics were evaluated using the R software package. Results High-risk HPV (hrHPV) genotypes were detected in 28.9% of SD and 35.1% of IM (P = 0.312). Penile swabs were more frequently positive for hrHPV genotypes than semen samples in both IM (32.3% vs. 11.9%, P < 0.001) and SD (26.8% vs. 6.2%, P = 0.006). Men with hrHPV positive semen samples had lower semen volume (median volume 2.5 ml vs. 3 ml, P = 0.009), sperm concentration (median concentration 16 × 106/ml vs. 31 × 106/ml, P = 0.009) and total sperm count (median count 46 × 106 vs. 82 × 106, P = 0.009) than men with hrHPV negative samples. No association was identified between penile hrHPV status and semen parameters. Conclusions Our findings indicate that penile HPV infection is common in both potential sperm donors and men from infertile couples. Although HPV positivity is higher in penile swabs, only HPV infection in semen samples affects sperm parameters. However, there was no association between hrHPV positivity in semen and fertility outcomes including abortion rate.

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Section: Methodsmentioning

confidence: 99%

Impact of human papillomavirus infection on semen parameters and reproductive outcomes

Jaworek

Koudeláková

Oborná³

et al. 2021

Reprod Biol Endocrinol

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“…The sensitivity slightly improved when analysis was restricted to 14 HR types (72%) or HPV16/18 only (81%). While the NS platform was able to detect a number of HPV types in epidemiological samples with No-PCR, its sensitivity was not comparable to other methods that incorporate target or signal amplification [9,26]. This suggested that sensitivity of the NS platform could be improved with the addition of PCR.…”

Section: Discussionmentioning

confidence: 92%

“…Supported by the Z-test results, we conclude that performance of HPV CodeSets is highly specific and reproducible regardless of the differences in PCR cycle number and diversity of samples (different anatomical sites, varying collection media and fixatives, varying extraction methods). In addition, PCR-15 is the preferred protocol for further validation studies since the products from PCR-15 could be hybridized directly, eliminating errors during dilution, and fewer amplification cycles have the advantage of reducing amplification bias in type detection [26]. The mean numbers of HPV types detected per sample by PCR-15 (5.3), LA (5.8) and TypeSeq (6.3) were similar, further supporting the comparability of the PCR-15 assay.…”

Section: Discussionmentioning

confidence: 99%

NanoString Technology for Human Papillomavirus Typing

Rajeevan

Patel

et al. 2021

Viruses

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High-throughput HPV typing assays with increased automation, faster turnaround and type-specific digital readout would facilitate studies monitoring the impact of HPV vaccination. We evaluated the NanoString nCounter® platform for detection and digital readout of 48 HPV types in a single reaction. NanoString (NS) used proprietary software to design CodeSets: type-specific probe pairs targeting 48 HPV types and the globin gene. We tested residual DNA extracts from epidemiologic specimens and defined samples (HPV plasmids at 10 to 104 copies/reaction) directly (No-PCR) as well as after L1 consensus PCR of 45 (PCR-45) or 15 cycles (PCR-15). Assay and interpretation followed NS recommendations. We evaluated analytic performance by comparing NanoString results for types included in prior assays: Roche Linear Array (LA) or HPV TypeSeq assay. No-PCR results on 40 samples showed good type-specific agreement with LA (k = 0.621) but sensitivity was 65% with lower limit of detection (LOD) at 104 plasmid copies. PCR-45 results showed almost perfect type-specific agreement with LA (k = 0.862), 82% sensitivity and LOD at 10 copies. PCR-15 results on 75 samples showed substantial type-specific agreement with LA (k = 0.796, 92% sensitivity) and TypeSeq (k = 0.777, 87% sensitivity), and LOD at 10 copies of plasmids. This proof-of-principle study demonstrates the efficacy of the NS platform with HPV CodeSet for type-specific detection using a low number of PCR cycles (PCR-15). Studies are in progress to evaluate assay reproducibility and analytic validation with a larger number of samples.

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“…After analysis, DNA extracted using a cobas x 480 instrument was subjected to HPV DNA detection and genotyping using PapilloCheck® HPV-Screening (Greiner Bio-One, Frickenhausen, Germany) [13]. In 40 samples where cobas® 4800 HPV Test and PapilloCheck® HPV-Screening were not concordant, LMNX Genotyping Kit HPV GP (Diassay, Rijswijk, The Netherlands) [14] was used for confirmation as described previously [12].…”

Section: Methodsmentioning

confidence: 99%

Prevalence of human papillomavirus infection in oocyte donors and women treated for infertility: An observational laboratory-based study

Jaworek

Zbořilová²,

Koudeláková

et al. 2019

European Journal of Obstetrics & Gynecology and Reproductiv

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Objective The aims of this study were to determine the prevalence of human papillomavirus (HPV) infection in women treated for infertility and oocyte donors, and to investigate the possible influence of HPV infection on reproductive outcomes. Study design In this observational laboratory-based study, cervical swabs were collected from oocyte donors (n = 207), and women treated for infertility (n = 945) and analysed for the presence of high-risk HPV (hrHPV) genotypes using the cobas® 4800 HPV Test and PapilloCheck® HPV-Screening. Associations between hrHPV positive status and fertility outcome or socio-behavioral and health characteristics were evaluated using R statistical software. Results HrHPV prevalence was significantly higher in oocyte donors than in women treated for infertility (28.0% vs . 16.1%, P < 0.001). Women who became pregnant spontaneously (19.6%) and women not treated with in vitro fertilization (IVF, 18.1%) were more frequently hrHPV positive than women treated with IVF (12.7%, P = 0.077). Despite the high prevalence of hrHPV in both oocyte donors and infertile women, no associations between hrHPV positive status and pregnancy or abortion rates were found in IVF treated women or in oocyte recipients. Moreover, no associations between hrHPV positive status and abortion rates were found in spontaneously pregnant women. Conclusion Despite the high prevalence of hrHPV in both oocyte donors and infertile women, HPV infection did not influence the outcomes of assisted reproductive technology.

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A Head-to-Head Analytical Comparison of Cobas 4800 HPV, PapilloCheck HPV Screening, and LMNX Genotyping Kit HPV GP for Detection of Human Papillomavirus DNA in Cervical and Cervicovaginal Swabs

Cited by 11 publications

References 33 publications

Impact of human papillomavirus infection on semen parameters and reproductive outcomes

Impact of human papillomavirus infection on semen parameters and reproductive outcomes

NanoString Technology for Human Papillomavirus Typing

Prevalence of human papillomavirus infection in oocyte donors and women treated for infertility: An observational laboratory-based study

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