ORCID Profile
0000-0003-4222-3176
Current Organisations
Queensland Department of Justice and Attorney-General
,
Cepheid
,
UNSW Graduate Research School
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Publisher: Elsevier BV
Date: 05-2019
DOI: 10.1016/J.CMI.2018.08.001
Abstract: Papua New Guinea has among the highest prevalences of sexually transmissible infections (STIs) globally with no services able to accurately test for anorectal Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections. Here we prospectively evaluated the diagnostic performance of a molecular CT/NG assay used at the point-of-care (POC) with the aim of enhancing anorectal STI screening and same-day treatment. Men who have sex with men, transgender women and female sex workers taking part in Papua New Guinea's first large-scale biobehavioural study were enrolled and asked to provide a self-collected anorectal swab for POC GeneXpert CT/NG testing. Same-day treatment was offered if positive. A convenience s le of 396 unique and randomly selected s les were transported to Australia for comparison using the Cobas 4800 CT/NG test (Roche Molecular Diagnostics, Pleasanton, CA, USA). A total of 326 s les provided valid results by Cobas whereas 70 s les provided invalid results suggesting inhibition. The positive, negative and overall percentage agreements of GeneXpert CT/NG for the detection of C. trachomatis were 96.7% (95% CI 92.3%-98.9%), 95.5% (95% CI 91.3%-98.0%) and 96.0% (95% CI 93.3%-97.8%), and for N. gonorrhoeae were 93.0% (95% CI 86.1%-97.1%), 100.0% (95% CI 98.3%-100.0%) and 97.8% (95% CI 95.6%-99.1%), respectively. The overall rate of agreement between the GeneXpert and Cobas CT/NG assays was high with 96.0% for C. trachomatis and 97.8% for N. gonorrhoeae. Results from this study data suggest that the GeneXpert CT/NG assay is suitable for testing self-collected anorectal specimens at the POC and that same-day treatment was feasible.
Publisher: F1000 Research Ltd
Date: 20-11-2019
DOI: 10.12688/WELLCOMEOPENRES.15173.2
Abstract: Background: Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods : The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery completed weeks of gestation as determined by ultrasound) and/or low birth weight ( g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032 .
Publisher: F1000 Research Ltd
Date: 22-03-2019
DOI: 10.12688/WELLCOMEOPENRES.15173.1
Abstract: Background: Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis and bacterial vaginosis have been associated with preterm birth and low birth weight, and are highly prevalent among pregnant women in many low- and middle-income settings. There is conflicting evidence on the potential benefits of screening and treating these infections in pregnancy. Newly available diagnostic technologies make it possible, for the first time, to conduct definitive field trials to fill this knowledge gap. The primary aim of this study is to evaluate whether antenatal point-of-care testing and immediate treatment of these curable sexually transmitted and genital infections (STIs) leads to reduction in preterm birth and low birth weight. Methods : The Women and Newborn Trial of Antenatal Interventions and Management (WANTAIM) is a cluster-randomised crossover trial in Papua New Guinea to compare point-of-care STI testing and immediate treatment with standard antenatal care (which includes the WHO-endorsed STI ‘syndromic’ management strategy based on clinical features alone without laboratory confirmation). The unit of randomisation is a primary health care facility and its catchment communities. The primary outcome is a composite measure of two events: the proportion of women and their newborns in each trial arm, who experience either preterm birth (delivery completed weeks of gestation as determined by ultrasound) and/or low birth weight ( g measured within 72 hours of birth). The trial will also evaluate neonatal outcomes, as well as the cost-effectiveness, acceptability and health system requirements of this strategy, compared with standard care. Conclusions: WANTAIM is the first randomised trial to evaluate the effectiveness, cost-effectiveness, acceptability and health system requirements of point-of-care STI testing and treatment to improve birth outcomes in high-burden settings. If the intervention is proven to have an impact, the trial will hasten access to these technologies and could improve maternal and neonatal health in high-burden settings worldwide. Registration: ISRCTN37134032 .
Publisher: BMJ
Date: 28-04-2015
Publisher: BMJ
Date: 10-05-2018
DOI: 10.1136/SEXTRANS-2017-053443
Abstract: A new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid lification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741) At 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated. Clinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8) NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0). In this first study reporting routine point-of-care use of GeneXpert CT/NG by primary care clinicians, we found excellent concordance with conventional NAATs. The use of the GeneXpert CT/NG at the point of care could potentially transform management and control of these infections in many endemic settings, including low/middle-income countries.
Publisher: BMJ
Date: 13-12-2014
DOI: 10.1136/SEXTRANS-2013-051246
Abstract: To evaluate the clinical performance of two chlamydia point-of-care (POC) tests compared with a gold standard nucleic acid lification testing (NAAT). Tests evaluated were the Chlamydia Rapid Test (CRT), Diagnostics for the Real World and the ACON Chlamydia Rapid Test Device, ACON Laboratories (ACON). Overall 226 men and 225 women in Port Vila, Vanuatu, participated in this prospective study in 2010. NAAT and POC testing was performed on s les of male urine and female vaginal swabs for 156 men and 223 women (CRT), and 133 men and 75 women (ACON). The sensitivity and specificity of the CRT in men were 41.4% (95% CI 23.5% to 61.1%) and 89.0% (95% CI 82.2% to 93.8%), respectively, and in women 74.2% (95% CI 61.5% to 84.5%) and 95.7% (95% CI 91.3% to 98.2%), respectively for ACON, they were 43.8% (95% CI 19.8% to 70.1%) and 98.3% (95% CI 93.9% to 99.8%) in men, and in women 66.7% (95% CI 22.3% to 95.7%) and 91.3% (95% CI 82.0% to 96.7%), respectively. Both tests were (absolutely) insensitive at organism loads less than 1000 (log=3) per mL or per swab the CRT sensitivity was significantly lower at loads less than, compared with those greater than, 100 000 (log=5) per mL or per swab. The performance of both CRT and ACON is well below the levels stated by the manufacturers. The evaluated tests are unlikely to be helpful in clinical settings due to the high proportion of false-negatives that will go untreated and false-positives that will result in overtreatment and potential adverse social consequences.
Publisher: American Society for Microbiology
Date: 07-2016
DOI: 10.1128/JCM.00529-16
Abstract: The World Health Organization has recommended that testing for high-risk human papillomavirus (HPV) (hrHPV) infection be incorporated into cervical screening programs in all settings worldwide. In many high-burden, low-income countries, it will not be feasible to achieve high cervical screening coverage using hrHPV assays that require clinician-collected s les. We conducted the first evaluation of self-collected vaginal specimens compared with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. Women aged 30 to 54 years attending two well-woman clinics in Papua New Guinea were invited to participate and provided self-collected vaginal and clinician-collected cervical cytobrush specimens. Both specimen types were tested at the point of care by using the Xpert HPV test. Women were given their cervical test result the same day. Those with a positive hrHPV test and positive examination upon visual inspection of the cervix with acetic acid were offered same-day cervical cryotherapy. A total of 1,005 women were enrolled, with 124 (12.3% 95% confidence interval [CI], 10.3%, 14.4%) being positive for any hrHPV infection. There was a 99.4% overall percent agreement (OPA) between vaginal and cervical tests for HPV-16 (95% CI, 98.9%, 99.9%), a 98.5% OPA for HPV-18/45 (95% CI, 97.7%, 99.3%), a 94.4% OPA for other hrHPV infections (95% CI, 92.9%, 95.9%), and a 93.4% OPA for all hrHPV types combined (95% CI, 91.8%, 95.0%). Self-collected vaginal specimens had excellent agreement with clinician-collected cervical specimens for the detection of hrHPV infection using the Xpert HPV test. This approach provides for the first time an opportunity to incorporate point-of-care hrHPV testing into clinical cervical screening algorithms in high-burden, low-income settings.
Publisher: JMIR Publications Inc.
Date: 13-06-2018
Abstract: emale sex workers (FSW), men who have sex with men (MSM), and transgender women (TGW) are at high risk of acquiring HIV in many settings, such as Papua New Guinea (PNG). An understanding of the approximate size of these populations can inform resource allocation for HIV services for FSW, MSM, and TGW. n objective of this multi-site survey was to conduct updated population size estimations (PSE) of FSW and MSM/TGW. espondent-driven s ling (RDS) biobehavioral surveys of FSW and MSM/TGW were conducted in 3 major cities—(1) Port Moresby, (2) Lae, and (3) Mount Hagen—between June 2016 and December 2017. Eligibility criteria for FSW included: (1) ≥12 years of age, (2) born female, (3) could speak English or Tok Pisin (PNG Pidgin), and (4) had sold or exchanged sex with a man in the past six months. Eligibility for MSM/TGW included: (1) ≥12 years of age, (2) born male, (3) could speak English, or Tok Pisin, and (4) had engaged in oral or anal sex with another person born male in the past six months. PSE methods included unique object multiplier, service multiplier, and successive s ling-population size estimation (SS-PSE) using imputed visibility. Weighted data analyses were conducted using RDS-Analyst and Microsoft Excel. le sizes for FSW and MSM/TGW in Port Moresby, Lae, and Mount Hagen included: (1) 673 and 400, (2) 709 and 352, and (3) 709 and 111 respectively. Keychains were used for the unique object multiplier method and were distributed 1 week before the start of each RDS survey. HIV service testing data were only available in Port Moresby and Mount Hagen and SS-PSE estimates were calculated for all cities. Due to limited service provider data and uncertain prior size estimation knowledge, unique object multiplier weighted estimations were chosen for estimates. In Port Moresby, we estimate that there are 16,053 (95% CI 8232-23,874) FSW and 7487 (95% CI 3975-11,000) MSM/TGW, approximately 9.5% and 3.8% of the female and male populations respectively. In Lae, we estimate that there are 6105 (95% CI 4459-7752) FSW and 4669 (95% CI 3068-6271) MSM/TGW, approximately 14.4% and 10.1% of the female and male populations respectively. In Mount Hagen, we estimate that there are 2646 (95% CI 1655-3638) FSW and 1095 (95% CI 913-1151) MSM/TGW using service multiplier and successive s ling, respectively. This is approximately 17.1% and 6.3% of the female and male populations respectively. s the HIV epidemic in PNG rapidly evolves among key populations, PSE should be repeated to produce current estimates for timely comparison and future trend analysis.
Publisher: Springer Science and Business Media LLC
Date: 16-05-2014
DOI: 10.1007/S10461-014-0791-2
Abstract: There is insufficient data on sexually transmitted infections (STI) and related behaviours among key populations, including female sex workers (FSW), in the Pacific region. Using respondent driven s ling, we conducted an integrated bio-behavioural survey with FSW in Vanuatu (aged ≥18 years) to investigate risk behaviours associations with Chlamydia trachomatis (CT). Weighted population estimates and correlates of CT infection were calculated. Among 149 FSW, prevalence of CT was 36 % (95 % CI 26-48 %). Few FSW reported consistent condom use with recent transactional sex partners (TSP) (8 % 95 % CI 2-13 %). CT infection was positively associated with increasing number of TSP (adjusted odds ratio [AOR] 1.1 95 % CI 1.0-1.2) and group sex (AOR 2.9 95 % CI 1.1-8.2). CT was negatively associated with increasing age of first sex (AOR 0.6 95 % CI 0.5-0.9) and previous STI treatment (AOR 0.1 95 % CI 0.0-0.4). A comprehensive public health strategy for prevention and treatment of STI among FSW, incorporating community empowerment strategies, FSW-targeted health services and periodic presumptive treatment, is urgently needed in Vanuatu.
Publisher: Springer Science and Business Media LLC
Date: 20-02-2019
Publisher: Cold Spring Harbor Laboratory
Date: 23-05-2020
DOI: 10.1101/2020.05.22.109983
Abstract: There is a pressing need for detailed knowledge of the range of pathogens, extent of co-infection and clinical impact of reproductive tract infections (RTIs) among pregnant women. Here, we report on RTIs ( Mycoplasma genitalium, Chlamydia trachomatis , Neisseria gonorrhoeae , Trichomonas vaginalis , Treponema pallidum subspecies pallidum, bacterial vaginosis and vulvovaginal candidiasis) and other sexual and reproductive health indicators among 699 pregnant women in Papua New Guinea (PNG). We found widespread M. genitalium infection (12.5% of women), the first time this pathogen has been reported in PNG, with no evidence of macrolide resistance. Most pregnant women (76.2%) had at least one RTI, most of which are treatable. Excluding syphilis, sexually-transmitted infections were detected in 37.8% women. Syndromic management of infections is greatly inadequate and there was remarkably little use of contraception 98.4% report never having used barrier contraception. This work has implications for improving maternal and child health in PNG. This first report of Mycoplasma genitalium in Papua New Guinea finds a high burden (12.5%) among 699 pregnant women. Additionally, more than one in two women were positive for a treatable reproductive tract infection associated with poor health outcomes.
Publisher: Springer Science and Business Media LLC
Date: 22-05-2019
Publisher: Cold Spring Harbor Laboratory
Date: 22-03-2020
DOI: 10.1101/2020.03.18.998104
Abstract: The Xpert HPV Test (Cepheid, Sunnyvale, CA) is used at point-of-care for cervical screening in a number of low-and middle-income countries (LMIC). It is validated for use with ThinPrep-PreservCyt (Hologic, Marlborough, MA) transport medium which has a high methanol content and is therefore classified as a dangerous good for shipping making cost, transportation and use challenging within LMIC. Therefore, we compared the performance of ThinPrep against four non-volatile commercially available media for HPV point-of-care testing. Ten-fold serial dilutions were prepared using three HPV cell lines each positive for 16, 18 or 31 and with each suspended in five different media types. The media types consisted of Phosphate Buffered Saline (Thermo Fischer Scientific, Waltham, MA, USA), Sigma Virocult (Medical Wire & Equipment, Wiltshire, England), MSwab (Copan, Brescia BS, Italy) Xpert Transport Media (Cepheid, Sunnyvale, USA) and ThinPrep-PreservCyt (Hologic Inc., Marlborough, MA). A total of 105 HPV Xpert tests were conducted in a laboratory setting, with 7 ten-fold dilutions of each of the 3 HPV genotypes tested in all 5 media types. The lowest HPV ten-fold dilution detected for any media, or cell line was the fifth dilution. Mswab was the only media to detect HPV to the 5 th dilution across all three cell types. Mswab transport media may be a suitable alternative to ThinPrep for Xpert HPV point of care testing and increase HPV detection. A field-based, head to head comparison of both media types using the Xpert HPV assay is warranted to confirm these laboratory-based findings.
Publisher: Springer Science and Business Media LLC
Date: 06-06-2016
Publisher: JMIR Publications Inc.
Date: 21-03-2019
DOI: 10.2196/11285
Publisher: BMJ
Date: 10-06-2019
DOI: 10.1136/SEXTRANS-2019-053961
Abstract: To characterise the Joint United Nations Programme on HIV/AIDS 90-90-90 cascade among female sex workers (FSW) and men who have sex with men (MSM)/transgender women (TGW) in Port Moresby, Papua New Guinea (PNG). We conducted respondent-driven s ling surveys among FSW and MSM/TGW in Port Moresby, PNG from June to October 2016. All participants spoke English or Tok Pisin and were aged years. FSW had to be born female and sell/exchange sex with a male in the past 6 months. MSM/TGW had to be born male and have oral/anal sex with another male-born person in the past 6 months. Participants were interviewed and offered rapid HIV diagnostic and viral load testing. HIV viral suppression (VS) was defined as copies/mL. We recruited 674 FSW and 400 MSM/TGW HIV prevalence was 15.2% (95% CI 11.7 to 18.8) and 8.5% (95% CI 5.0 to 11.9), respectively. Among FSW living with HIV, 39.0% (95% CI 26.6 to 51.4) self-reported having been diagnosed of them 79.6% (95% CI 62.7 to 96.5) self-reported being on antiretroviral therapy (ART), and 54.1% (95% CI 31.8 to 76.4) achieved VS. Among MSM/TGW living with HIV, 24.4% (95% CI 4.7 to 44.1) self-reported having been diagnosed of them 43.9% (95% CI 33.6 to 54.8) self-reported being on ART, and 86.1% (95% CI 71.1 to 93.9) achieved VS. ART use among those aware of their HIV status is encouraging. However, the generally low awareness of infection status among FSW and MSM/TGW with HIV and the low VS among FSW on ART indicate an urgent need for innovative strategies to increase testing uptake and ART adherence among these populations. Monitoring drug resistance may be warranted.
Publisher: JMIR Publications Inc.
Date: 09-2023
DOI: 10.2196/46701
Publisher: JMIR Publications Inc.
Date: 22-02-2023
Abstract: olecular point-of-care (POC) testing for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) has been available in regional and remote primary health services in Australia as part of a decentralised POC testing program for STIs since 2016 and SARS-CoV2 from 2020. As there was no suitable existing connectivity infrastructure to capture and deliver POC test results to a range of end users, a new system needed to be established. o design, implement, and optimise a connectivity system to meet clinical management, analytical quality management, and public health surveillance needs. e utilised commercially available e-messaging technology coupled with adapted proprietary software to integrate decentralised molecular POC testing platforms (GeneXpert). This connectivity infrastructure was designed to overcome key barriers to implementation, integration, and monitoring of these large multi-jurisdictional decentralised infectious disease POC testing networks. Test results messages were tailored to meet end-user needs and system requirements. Using centrally captured deidentified program data, we evaluated time to receipt of test result by test type and completeness of accompanying demographic data. rom January 2016 to April 2020, we operationalised the system at 31 health services across 4 jurisdictions and integrated with 5 different patient management systems (PMS) to support the real-time delivery of 29,356 CT/NG and TV test results to designated recipients (PMS, local clinical and central program databases). In 2019, 12,105 CT/NG and TV results were delivered, and the median time to receipt of result was 3.2 (IQR 2.2-4.6) hours, inclusive of test runtime. From May 2020 to August 2022, we optimised the system to support rapid scale up of SARS-CoV2 testing (105 services 6 jurisdictions 71,823 tests) and additional STI testing (16,232 tests), including the introduction of electronic disease specific notifications to jurisdictional departments of health, and alerts for connectivity disruption and positive results. In 2022, 19,355 results were delivered, with an overall median transmission time of 2.3 hours (IQR 1.4-3.1): 2.2 hours for SARS-CoV-2 (n=16,066) 3.0 hours for CT/NG (n=1,843) and 2.6 hours for TV (n=1,446). Demographic data (age, sex and ethnicity) were complete for 99% of test results in 2022. his innovative connectivity system designed to meet end-user needs has proven to be sustainable, flexible and scalable. It represents the first such system in Australia, established independent of traditional pathology providers, capable of supporting decentralised infectious diseases POC testing across a network of geographically dispersed remote primary health services. The system has been optimised to deliver real-time test results to a range of end users and has proven critical for clinical, public health, and quality management requirements and data analysis. The system has significantly supported the equitable access to rapid diagnostics for infectious diseases across Australia and its design is suitable for onboarding other POC tests and testing platforms in the future. >
Publisher: CSIRO Publishing
Date: 2020
DOI: 10.1071/SH19028
Abstract: Background The aim of this study was to compare the performance of pooled self-collected urogenital, pharyngeal and anorectal specimens to that of in idual specimen results for the molecular detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) near the point of care (POC) for diagnostic sensitivity. Methods: Clients (mostly men who have sex with men) attending an urban community testing service and three sex-on-premises venues in Brisbane, Australia, were offered CT and NG testing by trained lay providers. Participants provided three self-collected specimens (urine, pharyngeal and rectal) for testing by GeneXpert (Cepheid, Sunnyvale, CA, USA). If any of the in idual specimens from a participant were positive, all three specimens were pooled and retested. Results: Of the 388 participants who provided three in idual anatomical specimens, 76 (19.6%) were found to be positive for CT and/or NG at one or more sites. The pooling approach failed to detect five CT rectal and four NG pharyngeal infections. The overall performance (sensitivity) of the pooling approach compared with in idual specimen testing and Cohen’s κ were 90.0% and 0.86 respectively for CT and 89.7% and 0.89 respectively for NG. Conclusions: Reduced sensitivity was observed when using pooled specimens for the detection of CT and NG using GeneXpert near the POC, similar to results reported in laboratory-based CT and NG pooling studies. These data suggest specimen pooling is feasible near to the POC, potentially saving time and costs when screening at-risk populations for CT and NG. Our data also suggest a reduction in pooled urine could improve overall test sensitivity.
Publisher: BMJ
Date: 23-12-2015
DOI: 10.1136/SEXTRANS-2015-052384
Abstract: Global concerns regarding the prevalence, asymptomatic nature and burden of disease associated with Trichomonas vaginalis (TV) continue. The lack of a portable molecular point-of-care assay to detect this infectious disease has meant that many remote or low-resource settings still need to rely on delayed results from central laboratories and/or syndromic management as treatment strategies. We evaluated the new GeneXpert (Gx) TV nucleic acid lification test (NAAT) compared with an in-house laboratory NAAT to determine whether it would be suitable for use at the point of care. In a state-based laboratory and using their in-house NAAT, we selected the first 60 urine s les that were positive and the first 60 that were negative (n=120) in the study period for Gx TV testing in order to reduce collection delays and avoid the freezing of s les. Positive percentage agreement between the Gx TV and NAAT was 95.0% (95% CI 86.1% to 99.0%), negative percentage agreement was 100.0% (95% CI 93.5% to 100.0%) and overall percentage agreement was 97.4% (95% CI 92.5% to 99.5%). Three discordant results were detected with each being close to the cycle threshold of detection using the in-house NAAT assay. Findings suggest the Gx TV assay is easy to use and has suitable overall agreement for sexually transmissible infection (STI) testing at the point of care. It may be used in combination with the Gx CT/NG assay to test for all three STIs simultaneously using this portable and modular-based NAAT platform.
Publisher: Elsevier BV
Date: 02-2021
Publisher: Elsevier BV
Date: 11-2020
Publisher: Elsevier BV
Date: 04-2019
DOI: 10.1016/J.CMI.2018.05.025
Abstract: To compare the performance of self-collected vaginal (V) specimens with clinician-collected cervical (C) specimens for detection of high-risk human papillomavirus (hrHPV) and cervical disease using the Cepheid Xpert HPV, Roche Cobas 4800 HPV and Hologic Aptima HPV assays. Women aged 30-59 years (n = 1005) were recruited at two clinics in Papua New Guinea, and they provided specimens for testing at point-of-care using the Xpert HPV Test, and for subsequent testing using the Cobas HPV (n = 981) and Aptima HPV (n = 983) assays. Liquid-based cytology was performed on C specimens to predict underlying high-grade squamous intraepithelial lesions (HSIL). V specimen results of each assay were evaluated against a constructed reference standard and for detection of HSIL or worse. There was substantial (κ >0.6) agreement in hrHPV detection between V and C specimens across all three assays. The sensitivity, specificity, and positive and negative predictive values of Xpert HPV using self-collected V specimens for the detection of HPV type 16 according to the constructed reference standard were 92.1%, 93.1%, 63.6% and 98.9%, respectively compared with 90.4%, 94.3%, 67.8% and 98.7% for Cobas 4800 HPV and 63.2%, 97.2%, 75.0% and 95.3% for Aptima HPV. Similar results were observed for all hrHPV types (combined) and for HPV types 18/45, on all three assays. The detection of any hrHPV using self-collected specimens had high sensitivity (86%-92%), specificity (87%-94%) and negative predictive value (>98%) on all assays for HSIL positivity. Xpert HPV, using self-collected vaginal specimens, has sufficient accuracy for use in point-of-care 'test-and-treat' cervical screening strategies in high-burden, low-resource settings.
Location: Australia
Location: United Kingdom of Great Britain and Northern Ireland
No related grants have been discovered for Steven G Badman.