scholarly journals Multicenter Evaluation of the Cepheid Xpert® HBV Viral Load Test

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 297
Author(s):  
Fabbio Marcuccilli ◽  
Stephane Chevaliez ◽  
Thomas Muller ◽  
Luna Colagrossi ◽  
Giulia Abbondanza ◽  
...  

Accurate measurement of the hepatitis B virus (HBV) DNA is important for the management of patients with chronic HBV infection. Here, the performance of the Xpert® HBV Viral Load test (Xpert HBV Viral Load) versus the Roche COBAS® Ampliprep/COBAS® TaqMan® system (CAP/CTM HBV) HBV test v2.0 was evaluated. From September 2017 to December 2017, a total of 876 prospectively collected or archived serum or EDTA plasma specimens from subjects chronically infected with HBV were tested using the Xpert HBV Viral Load and the CAP/CTM HBV v2.0 assays. Of the 876 specimens tested, 560 were within the quantitative range of both assays. The agreement between the two methods was 90.0%. No difference in plasma or serum samples was observed. Deming regression analysis showed a good correlation of the Xpert HBV Viral Load assay with the CAP/CTM HBV v2.0 assay. The Bland–Altman analysis showed a good agreement between the results of the Xpert HBV Viral Load assay and the CAP/CTM HBV assay, with a mean difference (±1.96 standard deviation) of 0.0091 ± 0.3852 Log IU/mL. Comparing the two assays, only nineteen specimens (2.1%) had a difference greater than 1.96 times the standard deviation. The Xpert® HBV Viral Load test is suitable for monitoring patients with HBV infection and is useful in diagnostic settings.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1008.2-1008
Author(s):  
L. Fang ◽  
Z. Lin ◽  
Z. Liao ◽  
O. Jin ◽  
Y. Pan ◽  
...  

Background:Targeted synthetic DMARDs (ts-DMARDs) are becoming more available and affordable in developing countries, where the prevalence of hepatitis B virus (HBV) infection is still an important public health issue. The safety of ts-DMARDs therapy in terms of the reactivation of hepatitis B virus (HBV) infection need more concern. Rare data from a prospective study focus on the use of ts-DMARDs in patients with concurrent rheumatoid arthritis (RA) and HBV infection were available by now.Objectives:To evaluate the influence of tofacitinib on reactivation of HBV infection in HBsAg carriers with RA.Methods:In this 52 weeks observation, HBsAg carriers with active RA (DAS28>5.1) despite failed combined treatment with MTX and other non-biological DMARDs were enrolled. Patients must have normal liver function prior to study. All patients received therapy with tofacitinib (5mg twice daily) and concomitant MTX (10-12.5mg/w). Entecavir was prescribed preventively for patients who had a baseline HBV load >2000 copy/ml (group 1), and Lamivudin for patients with HBV load ≤ 2000 copy/ml (group 2). Liver enzymes (AST/ALT) and HBV viral load were monitored every 4 weeks. Increased viral load and abnormal liver function were managed according to expert opinion.Results:Thirteen patients (10 female) were recruited. Nine patients had a baseline viral load >2000 copy/ml (group 1, with preventive Entecavir), and the other 4 patients had a viral load ≤ 2000 copy/ml (group 2, with preventive Lamivudin). Two patients from group 1 discontinued tofacitinib at week 12 due to ineffectiveness, and both continued taking Entecavir for another 3 months after the discontinuation of tofacitinib.No reactivation of hepatitis B was observed in patients from group 1. One patients (female, 54 years old) from group 2 underwent a mild increase of both ALT and AST (67 and 56 IU/L, respectively) at week 16. An elevated viral load (4.9e6 copies/ml, baseline 1.4e3) and a HBV YMDD mutant was also found. The tofacitinib treatment continued. After prescription of Adefovir (combined with the pre-existing Lamivudin), both liver enzyme and viral load decreased to normal range in 8 weeks and remained normal throughout the study.Conclusion:An aggressive Tofacitinib + MTX therapy may be a safe option for HBsAg carriers with cs-DMARDs refractory RA. More active and effective prophylaxis strategy may be recommended to reduce the risk of HBV reactivation during the treatment.References:[1]Chen YM, Huang WN, Wu YD, et al. Reactivation of hepatitis B virus infection in patients with rheumatoid arthritis receiving tofacitinib: a real-world study. Ann Rheum Dis 2018; 77:780-2.Disclosure of Interests: :None declared


2021 ◽  
Vol 289 ◽  
pp. 114057
Author(s):  
Gezahegn Mekonnen Woldemedihn ◽  
Corina Silvia Rueegg ◽  
Hailemichael Desalegn ◽  
Hanna Aberra ◽  
Nega Berhe ◽  
...  

2019 ◽  
Vol 121 ◽  
pp. 104202
Author(s):  
Priska Bwana ◽  
Joshua Ageng’o ◽  
Jeff Danda ◽  
Joseph Mbugua ◽  
Allan Handa ◽  
...  

2020 ◽  
Author(s):  
Peter Nsubuga ◽  
Simbarashe Mabaya ◽  
Tsitsi Apollo ◽  
Ngwarai Sithole ◽  
Brian Komtenza ◽  
...  

BACKGROUND Zimbabwe has a high burden of HIV, with an estimated 1.3 million people living with the virus and an HIV prevalence and incidence of 13.8% and 0.48%, respectively (2017 Spectrum estimates). In 2017, the Zimbabwe Ministry of Health and Child Care (MOHCC) developed and implemented a pilot of HIV case surveillance (CS) based on the 2017 World Health Organisation (WHO) Person-centred HIV patient monitoring (PM) and case surveillance guidelines. As the case surveillance guidelines were new, lessons learned from field implementation experiences were intended to inform the development of HIV case surveillance implementation guidance and tools. OBJECTIVE At the end of the pilot phase, the Ministry of Health and Child Care (MOHCC) commissioned an evaluation to inform further steps. METHODS Two districts, Umzingwane in Matabeleland South Province and Mutare in Manicaland Province were commissioned to run the CS pilot from August 2017 to December 2018. During this period, 1602 people living with HIV (PLHIV) newly diagnosed with HIV were reported in the CS system, while other HIV sentinel events, including ART initiation and first viral load test, were routinely reported. A mixed-methods cross-sectional study of stakeholders and health facility staff was used to assess the following CS system features: design and operations, performance, usefulness, sustainability and scalability. A total of 13 stakeholders responded to an online questionnaire, while 33 health facility respondents were interviewed in 11 health facilities in the two pilot districts. RESULTS The HIV CS system was adequately designed for Zimbabwe’s context, integrated within existing health information systems at the facility level. However, the training was minimal, and an opportunity to train the data entry clerks in data analysis was missed. The system performed well in terms of surveillance and informatics attributes. However, viral load test results return was a significant problem. The system was used at the health facility level to track the HIV positive clients in their catchment area; all facilities that were visited were aware of what is happening to their clients. Almost all respondents believed that the country can roll out the HIV CS system to all facilities with partner support. CONCLUSIONS The HIV CS system was found useful at the health facility level and should be rolled out in a phased manner, beginning with all facilities in Manicaland and Matabeleland South provinces. An electronic link needs to be made between the health facilities and the laboratory to reduce viral load test results delays. Lessons learned from the provincial roll out can be used for a nationwide scale-up.


2001 ◽  
Vol 125 (12) ◽  
pp. 1546-1554
Author(s):  
Diane P. Francis ◽  
K. Michael Peddecord ◽  
Louise K. Hofherr ◽  
J. Rex Astles ◽  
William O. Schalla

Abstract Context.— Human immunodeficiency virus (HIV) RNA testing (viral load testing) is increasingly important in the care of patients infected with HIV-1 to determine when to initiate, monitor, and change antiretroviral therapy. Patient viral load testing information is communicated to the clinician through the laboratory test report. Objectives.—To examine the format and information used in reporting viral load testing results and determine the clarity of the information provided in these reports. Design.—Patient test reports with all personal identifiers removed were requested of viral load testing laboratories participating in a telephone survey of laboratory practices. Hospital, independent, health department, and “other type” laboratories identified as university-associated laboratories participated in the telephone survey. Results.—Thirty-seven unique test reports were collected. All laboratories reported results in copies/mL, while 14% also reported results as “log10 copies/mL.” The test kit was identified by only 24% of the laboratories. Reportable ranges were specified by 70% of the laboratories, but there was considerable variation in terminology. One laboratory reported a viral load copy number below the manufacturer's test kit lower limit of sensitivity. The layout and format differed among reports. Some results were expressed in log10, others contained nonsignificant integers, while others contained exponential numbers. Supplemental information in some reports included previous patient test results and significance of changes from baseline. The format of some reports made it difficult to read the report information and interpret the testing results. Conclusion.—This study emphasizes the importance of standardizing the reporting of HIV-1 viral load test results to minimize result misinterpretation and incorrect treatment.


2021 ◽  
pp. 095646242110552
Author(s):  
Mohammad Zubair Harooni ◽  
Abdul Alim Atarud ◽  
Ehsanullah Ehsan ◽  
Ajmal Alokozai ◽  
Willi McFarland ◽  
...  

Background Afghanistan adopted a “test and treat” strategy for all people living with HIV (PLWH) in 2016. In this study, we presented demographic and clinical characteristics of all people diagnosed between 2013 and 2019 and evaluated progress towards 90-90-90 UNAIDS targets and identified program gaps among PLWH in Afghanistan diagnosed in 2018. Methods We used clinical, behavioral, and demographic data from national HIV surveillance for 1394 patients diagnosed from 2013 through 2019. We also tracked 184 patients diagnosed with HIV in 2018 over 15 months to assess their enrollment in care, antiretroviral therapy (ART) initiation, retention on ART, and viral suppression. Results Of 1394 patients diagnosed from 2013 through 2019, 76.0% were male, 73.7% were older than 24 years, and 33.4% acquired HIV through heterosexual sex. Of the 184 patients diagnosed in 2018, 94.6% were enrolled in care, 88.6% received ART, 84.2% were retained on ART for at least 12 months, and 33.7% received a viral load test. Of those with a viral load test, 74.2% were virally suppressed. Patients who were 35–44 years old (52.0%, p-value .001), acquired HIV through unsafe injection (62.5%, p-value .413), were co-infected with hepatitis C virus (HCV) (60.0%, p-value .449), and with CD4 > 500 at diagnosis (64.7%, p-value .294) were less likely to be virally suppressed 12 months after diagnosis. Conclusion Nearly 95% of people diagnosed with HIV in Afghanistan in 2018 were linked to care and nearly 90% were on ART. Viral testing and viral suppression remain low with notable disparities for middle-aged patients, and possibly for those who injected drugs. Addressing barriers to HIV programs in Afghanistan, particularly for people who inject drugs (PWID), are urgently needed to reach the 90-90-90 global targets. Surveillance data on the number of people with undiagnosed HIV is needed to assess the first 90 target.


2016 ◽  
Vol 4 (1) ◽  
Author(s):  
Sean Galagan ◽  
Suzanne Jed ◽  
Jeri Sumitani ◽  
Jennifer M. Gilvydis ◽  
Albert Bakor ◽  
...  

Abstract Background South Africa has dual epidemics of human immunodeficiency virus (HIV) and tuberculosis (TB). Nurse-focused training was combined with onsite mentoring for nurses to improve HIV and TB care. A pre-/postevaluation was conducted in 3 districts in South Africa to assess the effects of the course on clinical patient monitoring and integration of TB and HIV care. Methods Two cross-sectional, unmatched samples of patient charts at 76 primary healthcare facilities were collected retrospectively in 2014 to evaluate the impact of training on treatment monitoring. Proportions of HIV patients receiving a viral load test 6 months after initiating antiretroviral therapy (ART) and TB patients receiving end of intensive phase sputum testing were compared pre- and posttraining. Analysis of creatinine clearance testing and integration of TB and HIV care were also performed. Results Data were analyzed from 1074 pretraining and 1048 posttraining records among patients initiating ART and from 1063 pretraining and 1008 posttraining among patients initiating TB treatment. Documentation of a 6-month viral load test was 36.3%, and a TB test at end of intensive phase was 70.7%, and neither increased after training. Among patients with a viral load test, the percentage with viral load less than 50 copies/mL increased from 48.6% pretraining compared with 64.2% posttraining (P = .001). Integration of TB and HIV care such as isoniazid preventive therapy increased significantly. Conclusions The primary outcome measures did not change after training. However, the evaluation documented many other improvements in TB and HIV care that may have been supported by the course.


2020 ◽  
Vol 96 (2) ◽  
pp. 114946 ◽  
Author(s):  
Florence Abravanel ◽  
Sébastien Lhomme ◽  
Pauline Trémeaux ◽  
Marion Migueres ◽  
Agnès Harter ◽  
...  

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