RealTime HIV-1 Assay Research Articles

Dolutegravir + Lamivudine vs. Dolutegravir + Tenofovir Disoproxil Fumarate/Emtricitabine: Very-Low-Level HIV-1 Replication through 144 Weeks in the GEMINI-1 and GEMINI-2 Studies.

In GEMINI-1/-2, dolutegravir + lamivudine was non-inferior to dolutegravir + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in achieving viral suppression (viral load [VL] < 50 copies/mL) in treatment-naive adults. Abbott's RealTime HIV-1 assay provides quantitative VL (40-10,000,000 copies/mL) and qualitative target detected or target not detected (TND) for VL < 40 copies/mL. This post hoc analysis assessed very-low-level viremia and "blips" through Week 144. Proportions with VL < 40 copies/mL and TND are presented overall and by baseline VL and CD4+ cell count. "Blips" (single VL ≥ 50 to <200 copies/mL with adjacent values < 50 copies/mL) were assessed from Day 1 after VL suppression and from Weeks 48 through to 144. Proportions with TND increased through Week 48 and were similar between groups at all visits (Week 144: dolutegravir + lamivudine, 451/716 [63%]; dolutegravir + TDF/FTC, 465/717 [65%]). By observed analysis, TND rates were similar between groups across baseline subgroups. Through Week 144, proportions with ≥1 "blip" were generally comparable for dolutegravir + lamivudine vs. dolutegravir + TDF/FTC from Day 1 (15% vs. 20%) and from Week 48 (7% vs. 11%). Through 144 weeks, the proportions with TND or "blips" were similar between dolutegravir + lamivudine and the three-drug comparator, reinforcing the efficacy and durability of dolutegravir + lamivudine.

Loss to Follow-up and Death Among Individuals With Newly Diagnosed Human Immunodeficiency Virus Receiving Dolutegravir-Based First-Line Antiretroviral Treatment in Eastern Ethiopia: Implications for 95% United Nations Targets.

Loss to follow-up (LTFU) and death are unfavorable outcomes of human immunodeficiency virus (HIV) treatment. This study aimed to identify the predictors of LTFU and death among individuals with newly diagnosed HIV receiving dolutegravir (DTG)-based first-line antiretroviral treatment (ART) in eastern Ethiopia. A multisite prospective cohort study was carried out between October 2020 and July 2022. New case patients who started ART were enrolled consecutively and then followed up for the next 6 months. A structured questionnaire and checklists were used to collect data. HIV viral load was determined using the Abbott RealTime HIV-1 assay. Bivariable and multivariable logistic regression models were used to identify baseline factors associated with the outcomes. A total of 235 people with newly diagnosed HIV were enrolled; 16.6% (95% confidence interval, 12.3%-21.9%) were lost to follow-up, and 5.9% (3.5%-9.8%) died within 6 months of follow-up. Baseline World Health Organization clinical stage I (adjusted odds ratio, 3.93 [95% confidence interval, 1.34-11.57]), low viral load (3.67 [1.09-12.36]), and body weight (1.04 [1.01-1.07]) were predictors of LTFU, whereas nonfunctional status (10.02 [1.9-51.3]) was the only factor associated with death. LTFU and death rates among patients with DTG were relatively high, accounting for roughly a quarter of the attrition of people with newly diagnosed HIV from ART care and services. Thus, targeted interventions are required to reduce LTFU and death among individuals with HIV on ART. Further investigation is necessary to evaluate the long-term effects of DTG-based regimens on LTFU and its impact on HIV mortality rates, and qualitative research, specifically tracing LTFU, is recommended.

Clinical performance evaluation of HCV and HIV-1 assays on the fully automated molecular system Alinity m

The demand for molecular virology testing continues to grow in clinical laboratories worldwide. The Alinity m system is a fully automated, continuous, random-access molecular diagnostic analyzer that was designed to streamline the laboratory workflow. In this study, we assessed the clinical performance characteristics of the Alinity m HCV and HIV-1 assays to detect and quantify these two bloodborne pathogens in 71 serum and plasma specimens. The overall qualitative agreement between the Alinity m and Abbott m2000 was 100 % for HCV and 94.4 % for HIV-1. Our data demonstrated a weak bias across the quantitative range of the Abbott m2000 and Alinity m HCV and HIV-1 assays, indicating a strong correlation on viral loads between them. Taken together, the Alinity m HCV and HIV-1 assays had comparable results to their current predecessors, the Abbott RealTime HCV and HIV-1 assays.

Virological Non-Suppression among Newly Diagnosed HIV-Positive Individuals on Dolutegravir-Based Antiretroviral Treatment in Eastern Ethiopia: Follow-Up Study.

There have been limited studies linking baseline factors, including the viral load (VL) test, with virological non-suppression since the introduction of dolutegravir (DTG)-based regimens as first-line antiretroviral treatment (ART) in Ethiopia. This study aimed to identify baseline factors associated with virological non-suppression between October 2020 and July 2022. A follow-up study was conducted in eastern Ethiopia among newly diagnosed people living with HIV (PLHIV). A questionnaire and a checklist were used to collect the data. Five milliliters of venous blood were obtained at baseline and six months to determine the VL. A VL test was performed using the Abbott RealTime HIV-1 assay. To determine predictors of virological non-suppression, bivariate and multivariate logistic regression analyses were used. There were 235 PLHIV enrolled, 70.6% of whom were female, with a mean age of 33.9 years. Of the 161 retained on ART, virological non-suppression was 8.7% at six months. Baseline predictors of virological non-suppression were age ≤ 30 years, a history of substance use, and a VL greater than 4-log10 copies/mL. In this cohort, virological non-suppression was found to be optimal but still lagged slightly behind the third 95%-target. Thus, targeted interventions, the introduction of baseline VL testing to improve treatment outcomes, and fostering the attainment of UNAIDS 95-95-95 targets are recommended. Furthermore, broader research is recommended to explore the reasons for virological non-suppression in the study area.

Serological Evidence of HIV/HBV Co-infection among HIV-infected patients in Onitsha, Anambra State, Nigeria

Research suggests that HIV-infected individuals who have also been co-infected with HBV face a greater risk of HIV progression. Hepatitis B and HIV infections pose serious public health challenges in sub-Saharan Africa. This study examined the possible HBV co-infection with the socio-demographic traits of HIV-infected individuals attending the HIV clinic at a referral specialist mission hospital in Onitsha, Anambra State, Nigeria. Two hundred and twenty (220) HIV-infected individuals gave consent to participate in the study. Between March 2022 and October 2022, blood samples (about 5ml) were aseptically collected during routine investigations into sterile EDTA bottles, and plasma samples were obtained by centrifugation. These samples were tested for HBsAg using a Monolisa HBsAg ULTRA kit (Bio-Rad, USA). CD4 counts were measured using the Partec CyFlow. Plasma viral loads (PVL) were also determined using the Abbott Real-Time HIV-1 Assay US protocol. HIV/HBV co-infection was 40.9%. The results showed that most (39.7%) study participants co-infected with HBV had a CD4 cell count of 350 cells/µl. The virological assay revealed that the highest HBsAg seroprevalence was detected in the study participants whose viral loads were between 40 and 1000µl (61.9%). The majority of the study participants were female HIV patients (74.5%), while those co-infected with HBV were mainly male patients (48.2%). HIV-positive individuals aged 18-30 (53.3%) were mostly affected. None of the socio-demographic variables tested was significantly associated with HBV in HIV-infected patients in Onitsha, Anambra State, Nigeria. This study showed a high HIV/HBV co-infection in Onitsha, Anambra State, Nigeria.

Co-infection of Hepatitis C among HIV-infected patients: A cross-sectional study from A University Teaching hospital in Anambra State, Nigeria

Hepatitis C virus co-infection (HCV) with HIV is regarded as a significant public health risk despite being less frequent than hepatitis B co-infection with HIV. This observation results from HIV's impact on the HCV life cycle and, ultimately, the hepatic system. In this study, potential HCV co-infection was examined in connection to the socio-demographic characteristics of HIV-positive patients attending an HIV clinic at a University Teaching Hospital in Awka, Anambra State, Nigeria. Between September 2021 and June 2022, 255 HIV patients who consented to participate in the study had their HCV levels checked using the anti-HCV antibody ELISA kit (DIA.PRO, Italy). Using the Partec CyFlow, CD4 counts were calculated. During routine investigations, blood samples (approximately 5ml) were aseptically collected into sterile EDTA vials, and plasma samples were obtained by centrifugation. With the aid of Abbott Real-Time HIV-1 Assay US methodology, plasma viral loads (PVL) were also calculated. A total of 11 (4.3%) HIV-positive people were also confirmed to have HCV infection, with women making up the majority (4.8%). Most of those affected were between the ages of 31 and 40 (6.8%). With marital status, HCV co-infection was found more amongst married patients, with a rate of 4.8%. The prevalence of HIV/HCV co-infection was higher (4.8%) in those with CD4 cell counts under &gt;350 cells per ml than others. Most patients (3.1%) did not have their viral RNA detected (TND). Self-employed infected persons and those with secondary school educational backgrounds had the highest HIV/HCV prevalence rate of 6.6% and 7.6%, respectively. The study's findings show no statistically significant relationships between the patients' socio-demographic traits and HCV. Also, HCV co-infection prevalence was significantly low in the study participants.

Comparison of the performance of Aptima HIV-1 Quant Dx Assay with Abbott RealTime HIV Assay for viral load monitoring using plasma and Dried Blood Spots collected in Kenya.

HIV-1 viral Load (VL) testing is recommended for the monitoring of antiretroviral treatment. Dried Blood Spots (DBS) are an effective sample type in resource limited settings, where safe phlebotomy and reliable shipping are hard to guarantee. In HIV high burden countries, high throughput assays can improve access to testing services. The Hologic Aptima HIV-1 Quant Dx Assay (Aptima Assay) is a high throughput assay that runs on the CE-IVD approved Panther platform. The objectives of this study were to assess the performance characteristics of Aptima for VL monitoring using plasma and venous DBS specimens and to determine the stability of HIV-1 RNA in DBS. This was a cross-sectional study of 2227 HIV infected adults visiting health facilities in Nairobi and Busia, Kenya. Each provided a venous blood sample; plasma was prepared from 1312 samples while paired DBS samples and plasma were prepared from the remaining 915 samples. The agreement between the Aptima assay and the Abbott RealTime HIV-1 Assay (Abbott RT) was analysed by comparing the HIV-1 VL in both assays at the medical decision point of 1000 copies/mL. To assess stability of HIV-1 RNA in DBS, VL in DBS spotted on day 0 were compared with that from the same DBS card after 21 days of storage at room temperature. Overall, 436 plasma samples had quantifiable results in both Aptima and Abbott RT. The agreement between the two assays at 1000 copies/mL was 97.48% with a Pearson's correlation coefficient (r) of 0.9589 and gave a mean bias of 0.33 log copies/mL on Bland-Altman analysis. For fresh DBS, the agreement in both assays was 94.64% at 1000 copies/mL, with an r of 0.8692 and a mean bias of 0.35 log copies/mL. The overall agreement between DBS tested in Aptima on day 0 versus day 21 was 95.71%, with a mean bias of -0.154. The Aptima HIV-1 Quant Dx assay is an accurate test for VL monitoring of HIV-1 using DBS and plasma sample types in Kenya.

Performance of Xpert HIV-1 viral load test in Senegal: a country of high circulation of CRF02_AG

Introductionthe introduction of the point-of-care in HIV-1 viral load quantification appears to be a complementary strategy to the existing conventional system of the acceleration plan for the achievement of the three 90s in Senegal. The objective of this study was to evaluate the performance of the Xpert® HIV-1 viral load in the context of circulation of non-B, non-C subtypes.Methodstwo hundred samples, were tested on Xpert® HIV-1 Viral Load using 1 ml of plasma in comparison to 600 μl on Abbott Real-time HIV-1 assay. The difference between viral load values was considered significant for Dlog <0.5 log copies/ml.Resultsa good correlation (r=0.985) was noted and confirmed using passing-bablok regression (slope 1.048; 95% CI: 1.036 to 1.069) for 188 samples with samples. A mean difference of 0.0075 log10 copies/ml for a 95% confidence interval (CI) of 0.002 log10 copies/ml to 0.013 log10 copies/ml was obtained. Sensitivity and specificity were respectively 93.6% and 93.5% at the threshold of 1.6 log10 copies/ml and 100% and 99% at the threshold of 3.0 log10 copies/ml.Conclusionthese results show that Xpert® HIV-1 Viral Load has excellent performance. In Senegal, and can be used for HIV viral load monitoring.

1163. HIV-1 NAAT Pitfalls in B-cell Lymphoblastic Leukemia Patients Following CAR-T Cell Therapy

BackgroundCAR-T Cell Therapy is approved for the treatment of pediatric patients with relapsed/refractory B-ALL. Lentiviral vector technology, highly modified from HIV-1, is used to induce stable, long-term transgene expression by integration into the host genome. This integration may interfere with HIV-1 NAAT producing false-positive results. MethodsA retrospective chart review of Pre-B ALL patients who underwent to CAR T cell therapy with KYMRIAH(tisagenlecleucel) at a single institution between January 2019 and May 2021 to assess for patients whose CAR-T infusion interfered with post-infusion HIV-1 testing. All patients had HIV NAAT pre and post CAR T-cell therapy (using platform, Roche COBAS AmpliPrep/Quantitative TaqMan HIV-1 T). Reactive HIV NAAT by Roche test were subsequently tested using different HIV-1 assay platforms to rule out or confirm HIV infection.ResultsWe report three cases in which interpretation of HIV-1 NAAT testing was complicated by CAR T cell therapy. Case 1: 1-year-old male with refractory infantile leukemia was found to have a reactive HIV NAAT post CAR-T in routine infectious screening prior to SCT. Case 2: 3-year-old refractory ALL planned for SCT who had a reactive HIV NAAT 9 months post CART. Fourth-generation HIV-1 testing (targeting the p24 antigen and anti-HIV-1 antibodies) was negative pre and post CART. Viral loads were also undetectable indicating false-positive post-CAR-T HIV-1 NAT test results. Case 3: 21-year-old sexually active female with relapsed B cell ALL. Post CAR-T HIV NAAT was reactive, and a quantitative viral load was positive at 176 copies/mm3 one day prior to start of stem cell transplant conditioning regimen. Aptima HIV testing is typically used as confirmatory test for CAR-T associated false positive HIV NAT cases, but surprisingly, the Aptima test was also reactive. Additional testing with Abbott m2000 Realtime HIV-1 assay and 4th generation p24 antigen-based testing were both negative. Table 1 Summary of reported patients with false-positive HIV-1 NAAT test results following CAR T cell therapy and Table 2, HIV platforms used for screening and diagnosis with interpretations following CAR T cell therapy.ConclusionClinicians need to be aware of potential false-positive HIV testing after CAR-T therapy. HIV testing platforms with targets not used in lentiviral vectors (4th generation test/P24, or Abbott test/integrase region) are highly recommended to avoid delays in subsequent therapy and unwanted stress for the patients, families, and cliniciansDisclosures All Authors: No reported disclosures

Evidence of HIV-1 Genital Shedding after One Year of Antiretroviral Therapy in Females Recently Diagnosed in Bamako, Mali.

Little is known about the dynamic of HIV-1 shedding and resistance profiles in the female genital reservoir after antiretroviral therapy (ART) initiation in resource-limited countries (RLCs), which is critical for evaluating the residual sexual HIV-1 transmission risk. The present study aimed to evaluate the efficacy of 1 year duration ART at blood and genital levels in females newly diagnosed for HIV-1 from three centers in Bamako, Mali. Seventy-eight consenting females were enrolled at the time of their HIV-1 infection diagnosis. HIV-1 RNA loads (Abbott Real-Time HIV-1 assay) were tested in blood and cervicovaginal fluids (CVF) before and 12 months after ART initiation. Primary and acquired resistances to ART were evaluated by ViroseqTM HIV-1 genotyping assay. The vaginal microbiota was analyzed using IonTorrentTM NGS technology (Thermo Fisher Scientific). Proportions of primary drug resistance mutations in blood and CVF were 13.4% and 25%, respectively. Discrepant profiles were observed in 25% of paired blood/CVF samples. The acquired resistance rate was 3.1% in blood. At month 12, undetectable HIV-1 RNA load was reached in 84.6% and 75% of blood and CVF samples, respectively. A vaginal dysbiosis was associated with HIV RNA shedding. Our findings emphasize the need of reinforcing education to improve retention in care system, as well as the necessity of regular virological monitoring before and during ART and of implementing vaginal dysbiosis diagnosis and treatment in RLCs.

Classification of HIV-1 virological treatment failure using the Roche cobas plasma separation card on cobas 8800 compared to dried blood spots on Abbott RealTime HIV-1

Measurement of HIV-1 viral load (VL) is essential for monitoring antiretroviral treatment (ART) efficacy. In remote settings, dried blood spots (DBS) may be used as the specimen type. However, cellular components in DBS not present in the gold standard specimen type, plasma, may result in low specificity i.e., over-estimation of VL results from DBS compared to plasma. The Abbott RealTime HIV-1 assay system has been reported to have improved specificity using DBS compared to other tests. A new specimen collection matrix, the cobas plasma separation card (PSC, Roche Molecular Systems), enables specimen collection from a finger prick or venous blood, using a multi-layer absorption and filtration design that results in a specimen similar to plasma. We performed a direct comparison between VL results from PSC tested with the cobas 6800/8800 assay (c8800) and DBS tested with the Abbott RealTime HIV-1 assay. Overall concordance between PSC and plasma around the 1000 copies/mL threshold was high (>97%). Compared to VL measured using DBS and the RealTime assay, PSC and c8800 showed improved sensitivity (96.9% vs 90.6%) and specificity (97.4% vs. 87.2%) using plasma as the reference, as there were fewer patients with VL below 1000 copies/mL in plasma in whom VL was over this threshold using PSC compared to DBS. The limit of detection for PSC was lower than for DBS (575 vs. 2314 copies/mL). cobas PSC represents a promising specimen type for use with the cobas 6600/8800 system in settings where plasma cannot be used.

Prospective evaluation of accuracy of HIV viral load monitoring using the Aptima HIV Quant Dx assay with fingerstick and venous dried blood spots prepared under field conditions in Kenya.

Quantification of HIV-1 RNA is essential for clinical management of HIV patients. The limited throughput and significant hands-on time required by most HIV Viral load (VL) tests makes it challenging for laboratories with high test volume, to turn around patient results quickly. The Hologic Aptima HIV-1 Quant Dx Assay (Aptima), has the potential to alleviate this burden as it is high throughput and fully automated. This assay is validated for both plasma and dried blood spots (DBS), which are commonly used in resource limited settings. The objective of this study was to compare the performance of Aptima to Abbott RealTime HIV-1 Assay (Abbott RT), which was used as reference. This was a cross-sectional prospective study where HIV VL in finger stick (FS) DBS, venous blood (VB) DBS and plasma, collected from 258 consenting adults visiting 5 medical facilities in Kenya, Africa were tested in Aptima. The results were compared to plasma VL in Abbott RT at the medical decision point (MDP) of 1000 copies/mL and across Aptima assay range. The total agreement at MDP between plasma HIV VL in Abbott RT and plasma, FS and VB DBS tested in Aptima were 97.7%, 92.2% and 95.3% respectively with kappa statistic of 0.95, 0.84 and 0.90. The positive and negative agreement for all 3 sample types were >92%. Regression analysis between VL in Abbott RT plasma and various sample types tested in Aptima had a Pearson’s correlation coefficient ≥0.91 with systematic bias of < 0.20 log copies/mL on Bland-Altman analysis. The high level of agreement in Aptima HIV VL results for all 3 sample types with Abbott RT plasma VL along with the high throughput, complete automation, and ease of use of the Panther platform makes Aptima a good option for HIV VL monitoring for busy laboratories with high volume of testing.

1021. HIV-1 RNA Blips and Low-Level Replication During Phase III/IIIb Cabotegravir + Rilpivirine Long-Acting Studies Are Similar to Oral 3-Drug Therapy and Not Associated with Week 48 Virologic Outcome

BackgroundPhase III/IIIb studies demonstrated cabotegravir (CAB) + rilpivirine (RPV) long-acting (LA) dosed every 4 weeks (Q4W) was noninferior to current antiviral regimen (CAR) (FLAIR and ATLAS) and CAB + RPV LA dosed every 8 weeks (Q8W) was noninferior to Q4W (ATLAS-2M) through Week 48 (W48). HIV-1 ribonucleic acid (RNA) blips (viral load [VL] ≥50 to < 200 c/mL) are common during antiretroviral therapy (ART) and generally not associated with subsequent virologic failure (2 consecutive HIV-1 RNA ≥200 c/mL). We compared the frequency of HIV-1 RNA blips and low-level qualitative and quantitative HIV-1 RNA replication among participants treated with CAB+RPV LA and oral CAR and assessed impact on virologic outcome.MethodsPlasma samples collected at study visits were analyzed for HIV-1 RNA viral load using the Abbott RealTime HIV-1 assay and qualitative target detected (TD) or target not detected (TND) outcomes were provided for HIV-1 RNA < 40 c/mL. The HIV-1 SuperLow assay (bioMONTR Labs) was used to measure HIV-1 RNA < 2 c/mL at Baseline and W48.ResultsThe proportion of participants with HIV-1 RNA blips was similar overall between Q4W CAB + RPV LA and CAR arms in FLAIR (38/283 [13%] vs 39/283 [14%]) and ATLAS (17/308 [6%] vs 23/308 [7%]). Presence of HIV-1 RNA blips in either arm was not associated with virologic non-response at W48 (HIV-1 RNA ≥50 c/mL per US Food and Drug Administration Snapshot). In ATLAS-2M, HIV-1 RNA blips were observed in 32/523 (6%; Q4W) and 18/522 (3%; Q8W) of participants, with W48 virologic nonresponse in 2 Q4W and 0 Q8W participants. TD outcomes at individual study visits were comparable between study arms for the 3 studies. At W48, the proportion of participants with HIV-1 RNA < 2 c/mL was similar to Baseline and similar between treatment groups in all studies.ConclusionThe proportions of study participants with HIV-1 RNA blips, TD viral load results, and HIV-1 < 2 c/mL were similar between the Q4W and Q8W CAB+RPV LA and the oral 3-drug CAR arms through W48 in phase III/IIIb studies. HIV-1 RNA blips did not predict virologic nonresponse (Snapshot analysis) at W48.DisclosuresChristine L. Talarico, M.S, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sterling Wu, PhD, GlaxoSmithKline (Employee, Shareholder) Marty St. Clair, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Veerle Van Eygen, MSc, Janssen Pharmaceutica NV (Employee) Krischan J. Hudson, PhD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Sandy Griffith, PharmD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) Conn M. Harrington, BA, ViiV Healthcare (Employee) Jan van Lunzen, MD, PhD, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) David Margolis, MD, MPH, GlaxoSmithKline (Shareholder)ViiV Healthcare (Employee) William Spreen, PharmD, ViiV Healthcare (Employee, Shareholder)

Implementation and operational feasibility of SAMBA I HIV-1 semi-quantitative viral load testing at the point-of-care in rural settings in Malawi and Uganda.

We monitored a large-scale implementation of the Simple Amplification-Based Assay semi-quantitative viral load test for HIV-1 version I (SAMBA I Viral Load=SAMBA I VL) within Médecins Sans Frontières' HIV programmes in Malawi and Uganda, to assess its performance and operational feasibility. Descriptive analysis of routine programme data between August 2013 and December 2016. The dataset included samples collected for VL monitoring and tested using SAMBA I VL in five HIV clinics in Malawi (four peripheral health centres and one district hospital), and one HIV clinic in a regional referral hospital in Uganda. SAMBA I VL was used for VL testing in patients who had been receiving ART for between 6months and ten years, to determine whether plasma VL was above or below 1000 copies/mL of HIV-1, reflecting ART failure or efficacy. Randomly selected samples were quantified with commercial VL assays. SAMBA I instruments and test performance, site throughput, and delays in communicating results to clinicians and patients were monitored. Between August 2013 and December 2016 a total of 60889 patient samples were analysed with SAMBA I VL. Overall, 0.23% of initial SAMBA I VL results were invalid; this was reduced to 0.04% after repeating the test once. Global test failure, including instrument failure, was 1.34%. Concordance with reference quantitative testing of VL was 2620/2727, 96.0% (1338/1382, 96.8% in Malawi; 1282/1345, 95.3% in Uganda). For Chiradzulu peripheral health centres and Arua Hospital HIV clinic, where testing was performed on-site, same-day results were communicated to clinicians for between 91% and 97% of samples. Same-day clinical review was obtained for 84.7% across the whole set of samples tested. SAMBA I VL testing is feasible for monitoring cohorts of 1000 to 5000 ART-experienced patients. Same-day results can be used to inform rapid clinical decision-making at rural and remote health facilities, potentially reducing time available for development of resistance and conceivably helping to reduce morbidity and mortality.

Analysis of HIV/Malaria Coinfections among HIV-1 Infected Individuals in Two Tertiary Hospitals in Old Cross River State, Nigeria

Aims: Human Immunodeficiency Virus (HIV) and Malaria are the two main global public health threats that dent development in low and middle-income countries. This study evaluated the immunological marker and HIV/Malaria co-infection among individuals infected with HIV-1 in old Cross River State, Nigeria.&#x0D; Study Design: Cross-sectional study.&#x0D; Place and Duration of Study: University of Calabar Teaching Hospital (UCTH) and University of Uyo Teaching Hospital (UUTH) between March 2018 and August 2019.&#x0D; Methods: A total of 417 individuals infected with HIV-1 partook in this study. The age of these individuals ranged from 4-72 years (average age = 39.1 years). Plasma samples were analyzed for HIV and Malaria using Enzyme-Linked immunosorbent Assay. The CD4 count was enumerated using the Partec CyFlow® Counter. Plasma viral loads (PVL) were determined using the Abbott Real-Time HIV-1 assay.&#x0D; Results: Results showed that 230(55.1%) of the participants were in the 31-45 years age range. The majority (67.4%) of the HIV-1 infected individuals were females. An overall prevalence of HIV/Malaria coinfection in Old Cross River State, Nigeria was 14.3%, of which Uyo was 6.3% and Calabar was 3.0%. A higher prevalence of HIV/Malaria coinfection was observed among age groups &lt;25 years (17.5%), males (5.1%), singles or divorced/widow/widower (7.7%), those with primary education (7.5%), and students (10.0%). Higher HIV/Malaria coinfection was also observed among those with CD4 cell count &lt;200 cells/μl and 350-499 cells/μl (5.7%) and PVL &gt;5000 copies/mL (7.9%) compared to others with 2.0% prevalence. Of all variables evaluated only marital status (p= 0.033), educational background (p= 0.000) and occupations (p =0.000) were significantly associated.&#x0D; Conclusions: This study further confirmed the presence of HIV/Malaria coinfection in old Cross River State, Nigeria. This study has added to the voices on the ground to give a better view on the frequency and the pattern of distribution of HIV/Malaria coinfection since limited studies have been done on this in old Cross River State, Nigeria. This, therefore, highlights the need for a well-structured approach to the management of HIV/Malaria coinfection in Nigeria.

Multicenter evaluation of Xpert HIV-1 viral load assay for HIV quantification in China.

New approaches to increase HIV-1 testing and HIV-1 viral load (VL) monitoring are needed for people living with HIV (PLHIV) in China. The Xpert HIV-1 VL assay was prequalified by the World Health Organization in 2017 but has not been evaluated in China. A multicenter evaluation was conducted to assess the accuracy of the Cepheid Xpert HIV-1 VL assay compared to the Abbott RealTime HIV-1 assay in China.Overall agreement was seen in 558 of 562 specimens (99.29%) with a κ value of 0.962. Pearson's coefficient between the two assays was 0.943. Analyzed by the Bland-Altman method, the mean bias was -0.54 log10 copies/mL, and 94.05% results fell within the 95% confidence limit of agreement (-1.248 to 0.168 log10 copies/mL). The coefficient of variation of the Cepheid Xpert HIV-1 VL assay ranged from 0.61% to 1.55%, as determined by testing eight positive plasma specimens with three different lots on different days. Due to its simplicity, random-access, rapid turnaround time, and accuracy, the Xpert HIV-1 VL assay can be used in local hospitals and clinics that bear the burden of identifying and treating HIV patients in China.

Whatman FTA cards versus plasma specimens for the quantitation of HIV-1 RNA using two real-time PCR assays.

BackgroundSeveral studies have compared the use of dried blot spot (DBS) as an alternative to plasma specimens, mainly using Whatman 903 cards as filter paper. The aim of this study was to evaluate the use of Whatman FTA card (FTA card) specimens for HIV-1 viral load testing compared to plasma specimens using two real-time PCR assays manufactured by Roche and Abbott.Methodology A cross-sectional study was conducted between April 2017 and September 2017 on HIV-1 patients admitted to Yalgado Ouédraogo Teaching Hospital. Paired FTA cards and plasma specimens were collected and analysed using the Abbott Real-Time HIV-1 assay (Abbott) and COBAS AmpliPrep/COBAS TaqMan v2.0 (Roche).Results In total, 107 patients were included. No statistical differences (P>0.05) were observed between the mean viral loads obtained from the FTA cards and those of the plasma specimens using the Roche and Abbott assays. In total, 29 samples with Roche and 15 samples with Abbott assay showed discrepant results. At viral loads of ≤1000 copies ml−1, the sensitivity and specificity of the FTA cards were 78.6 and 100% with Roche, and 92.3 and 95.9% with Abbott, respectively. Both the Roche and Abbott assays showed good correlation and agreement between the FTA cards and plasma values.Conclusion Our study demonstrates the feasibility of using FTA card filter paper for HIV-1 viral load testing. However, further studies will be required for the validation of the use of FTA card filter paper in HIV-1 treatment monitoring.

Evaluation of the automated aptima HIV-1 quant Dx assay for both qualitative and quantitative testing in pediatric patients

BackgroundThere are currently no FDA-cleared assays with a dual-claim for both diagnosis and monitoring of HIV-1. The Aptima HIV-1 Quant Dx Assay on the Panther platform (Panther) is the first commercially available test that is CE-marked for both HIV-1 diagnosis and monitoring, but only FDA-cleared for HIV-1 monitoring. ObjectiveTo evaluate the Panther assay for use as a qualitative and quantitative HIV-1 assay in a pediatric population, including patients younger than 24 months old, and review its effect on laboratory efficiency and hands-on-time following its implementation. Study Design100 patient specimens previously tested on the Abbott m2000 RealTime HIV-1 assay (RealTime) and 185 patient specimens previously tested on the Aptima HIV-1 RNA Qualitative Assay (RNA Qual) were tested on the Panther. Verification panels were used to establish precision and linearity. In addition, 268 samples from 134 patients under 24 months of age were also evaluated on the Panther. ResultsOverall agreement between the Panther and RealTime assays was 83 %. The mean difference between the two methods was 0.10 Log copies/mL. All Panther measurements were linear across the dynamic range (R2 = 0.999). The Panther and RNA Qual assays showed 100 % agreement. Implementation of the assay opened 600 sq. ft. of space, saved 0.4 FTE and reduced hands-on-time by 70 %. ConclusionsThe Panther assay is an excellent option for HIV-1 qualitative detection and quantitative testing in pediatric patients, including those under 24 months of age. HIV testing on one platform has opened up space in the clinical laboratory and reduced hands on testing time.

HIV coinfections with tuberculosis among HIV-1 infected individuals in old cross river state, Nigeria

ABSTRACTHuman immunodeficiency virus (HIV) and Tuberculosis (TB) are two main global public health threats that dent development in low and middle-income countries. This study evaluated the HIV/TB co-infection rate among HIV-1 infected individuals in old Cross River State, Nigeria. A total of 417 HIV-infected individuals participated in this study, 241 (57.8%) from Calabar, Cross River State, Nigeria and 176 (42.2%) from Uyo, Akwa-Ibom State, Nigeria. The age range of the 417 HIV-1 positive individuals who participated in the study was 4–72 years with an average age of 39.1 years. Plasma samples were analyzed for HIV and TB using fourth-generation Enzyme-Linked immunosorbent Assay. The CD4 count was enumerated using the Partec CyFlow® Counter. Plasma viral loads (PVL) were determined using the Abbott Real-Time HIV-1 assay. Results showed that 230 (55.2%) of the participants were in the 31–45 years age range. The majority (67.4%) of the HIV-1 infected individuals were females and 32.6% were males. An overall prevalence of HIV/TB coinfection in Old Cross River State, Nigeria was 1.4%, with Akwa Ibom State (0.6%) and Cross River State (1.2%). A higher prevalence of HIV/TB coinfection was observed among females (1.8%) than in males (0.7%). Higher prevalences of HIV/TB coinfections was observed in patients above 45 years of age (2.2%), married (2.3%), tertiary education (1.8%) followed by those with secondary education (1.4%), traders and civil servants (3.1%), patients with CD4 counts 200–349 and ≥500 cells/μl (1.9%), and those with viral load <40 copies/mL (2.7%). This study confirmed the presence of HIV/TB co-infection in old Cross River State, Nigeria. Although the prevalence rate of HIV/TB coinfection was low, its presence alone among HIV-1 infected individuals makes it a major source of concern. This finding highlights the need for a well-structured approach to the management of co-infection, and this includes both the social and medical aspects of the problem.

Female genital tract shedding of HIV-1 is rare in women with suppressed HIV-1 in plasma.

Determine the frequency of genital HIV-1 shedding in a large cohort of women on long-term suppressive antiretroviral therapy (ART) and its association with mucosal inflammation. We measured levels of HIV-1 RNA and inflammation biomarkers in cervicovaginal lavage (CVL) from HIV-seropositive women enrolled in the Women's Interagency HIV Study (WIHS). HIV-1 was quantified (Abbott RealTime HIV-1 assay) from CVL samples of 332 WIHS participants with and without clinical evidence of genital inflammation at the time of CVL collection; participants had suppressed plasma viral load (PVL; limit of quantitation less than 20-4000 copies/ml depending on year of collection) for a median of 7.1 years [interquartile range (IQR) 3.4-9.8, Group 1] or for a median of 1.0 years (IQR = 0.5-1.0, Group 2). Twenty-two biomarkers of inflammation were measured in CVL to compare with clinical markers. HIV-1 was detected in 47% of 38 pre-ART CVL samples (median 668 copies/ml) and detection in CVL was associated with higher pre-ART PVL. HIV-1 was detected in only 1 of 38 CVL samples from these women on suppressive antiretroviral therapy for 1 year. No HIV-1 RNA was detected in 294 CVL samples from a cross-sectional set of women with suppressed PVL for a median of 7 years. Clinical inflammation markers were correlated with inflammatory biomarkers in CVL specimens, although genital inflammation was not associated with measurable genital HIV-1 shedding in these WIHS participants on ART. ART that suppresses HIV-1 in the plasma of women also prevents genital tract HIV-1 shedding, even in the presence of genital tract inflammation.