scholarly journals Performance of an Alternative Laboratory-Based HIV Diagnostic Testing Algorithm Using HIV-1 RNA Viral Load

2020 ◽  
Vol 47 ◽  
pp. S18-S25 ◽  
Author(s):  
Marc A. Pitasi ◽  
Shilpa N. Patel ◽  
Laura G. Wesolowski ◽  
Silvina Masciotra ◽  
Wei Luo ◽  
...  
Keyword(s):  
Viral Load ◽  
Diagnostic Testing ◽  
Testing Algorithm ◽  
Hiv 1

scholarly journals An HIV Diagnostic Testing Algorithm Using the cobas HIV-1/HIV-2 Qualitative Assay for HIV Type Differentiation and Confirmation

2021 ◽  
Author(s):  
Dana Duncan ◽  
John Duncan ◽  
Bastian Kramer ◽  
Alex Y. Nilsson ◽  
Betiel Haile ◽  
...  
Keyword(s):  
Diagnostic Testing ◽  
Diagnostic Algorithm ◽  
Nucleic Acid Amplification ◽  
Hiv Rna ◽  
Qualitative Test ◽  
Qualitative Assay ◽  
Testing Algorithms ◽  
Testing Algorithm ◽  
Positive Groups ◽  
Hiv 1

HIV-1 and HIV-2 diagnostic testing algorithms recommended by the Centers for Disease Control involve up to three tests and rely mostly on detection of viral antigen and host antibody responses. HIV-1 p24 antigen/HIV-1/2 antibody reactive specimens are confirmed with an immunochromatographic HIV-1/HIV-2 antibody differentiation assay and negative or indeterminate results from the differentiation assay are resolved by an HIV-1-specific nucleic acid amplification test (NAT). The performance of a proposed alternative algorithm using the cobas HIV-1/HIV-2 Qualitative NAT as the differentiation assay was evaluated in subjects known to be infected with HIV-1 (N=876) or HIV-2 (N=139), at low (N=6017) or high (N=1020) risk of HIV-1 infection, or at high-risk for HIV-2 infection (N=498) (Study A). The performance of the cobas HIV-1/HIV-2 Qualitative test was also evaluated by comparison to an HIV-1 or HIV-2 alternative NAT (Study B). The HIV-1 and HIV-2 overall percent agreements (OPA) in Study A ranged from 95%-100% in all groups. The positive percent agreements (PPA) for HIV-1 and HIV-2 were 100% (876/876) and 99.4% (167/168) respectively for known positive groups. The negative percent agreement in the HIV low-risk group was 100% for both HIV-1 and HIV-2. In Study B, the HIV-1 and HIV-2 OPA ranged from 99%-100% in all groups evaluated (N: 183 to 1030), and the PPA for HIV-1 and HIV-2 were 100% and 99.5% respectively for known positive groups. The cobas HIV-1/HIV-2 Qualitative Assay can discriminate between HIV-1 and HIV-2 based on HIV RNA, and can be included in an alternative diagnostic algorithm for HIV.

scholarly journals 83The Performance of Quantitative HIV-1 RNA Testing (Viral Load) to Diagnose Acute HIV Infection in the New HIV Laboratory Testing Algorithm

2014 ◽  
Vol 1 (suppl_1) ◽  
pp. S5-S5
Author(s):  
Hsiu Wu ◽  
Stephanie Cohen ◽  
Emily Westheimer ◽  
Cindy Gay ◽  
Laura Hall ◽  
...  
Keyword(s):  
Viral Load ◽  
Hiv Infection ◽  
Laboratory Testing ◽  
Acute Hiv Infection ◽  
Acute Hiv ◽  
Testing Algorithm ◽  
Hiv 1

Diagnosing acute HIV infection: The performance of quantitative HIV-1 RNA testing (viral load) in the 2014 laboratory testing algorithm

2017 ◽  
Vol 93 ◽  
pp. 85-86 ◽  
Author(s):  
Hsiu Wu ◽  
Stephanie E. Cohen ◽  
Emily Westheimer ◽  
Cynthia L. Gay ◽  
Laura Hall ◽  
...  
Keyword(s):  
Viral Load ◽  
Hiv Infection ◽  
Laboratory Testing ◽  
Acute Hiv Infection ◽  
Acute Hiv ◽  
Testing Algorithm ◽  
Hiv 1

scholarly journals Assessment of the Sedia HIV Self-Test Device: Usability and Performance in the Hands of Untrained Users in Johannesburg, South Africa

Diagnostics ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. 1816
Author(s):  
Mohammed Majam ◽  
Naleni Rhagnath ◽  
Vanessa Msolomba ◽  
Leanne Singh ◽  
Michael S. Urdea ◽  
...  
Keyword(s):  
South Africa ◽  
Diagnostic Testing ◽  
Efficacy Analysis ◽  
Usability Assessment ◽  
Self Testing ◽  
Novice Users ◽  
Self Test ◽  
And Performance ◽  
Testing Algorithm ◽  
Hiv 1

The prevalence of HIV across South Africa places a strain on testing facilities. The use of HIV self-testing (HIVST) devices has been identified as a strategy to ease the burden on these facilities. The usability and performance of the Asante HIV−1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland OR, USA) device by novice users was assessed and reported on, to inform for the implementation of such devices in South Africa and elsewhere. Convenience sampling was used. Participants used the Asante HIVST device and recorded their interpretation of their results. Participants’ interpretations were compared with those of trained professionals and, thereafter, verified using the rapid diagnostic testing algorithm. Out of the eligible participants, 410 of the 524 (78.2%) were between the ages of 18–35. The usability assessment indicates that 100% of participants used the HIVST device’s information leaflet. However, 19/524 (3.6%) of participants who yielded an invalid result due to critical errors were excluded from the primary efficacy analysis. The average usability score was 98.1%. The sensitivity and specificity results were, 94.7% and 99.8%, respectively. This study shows that the Asante HIV self-test, and similar devices, can be valuable in providing convenient HIV self-testing and immediately available results. To accommodate a greater number of inexperienced users, the instructions may need to be revised.

Improved Performance of COBAS AmpliPrep/COBAS TaqMan Version 2.0 Assay Over Amplicor Monitor Version 1.5 in the Quantification of HIV-1 RNA Viral Load in Abuja, Nigeria

2015 ◽  
Vol 13 (4) ◽  
pp. 262-267 ◽  
Author(s):  
Ado Abubakar ◽  
Nicaise Ndembi ◽  
Obinna Ogbanufe ◽  
Auchi Inalegwu ◽  
Simi Wilson ◽  
...  
Keyword(s):  
Viral Load ◽  
Cobas Taqman ◽  
Version 2.0 ◽  
Improved Performance ◽  
Hiv 1

Effectiveness, Durability, and Safety of Dolutegravir and Lamivudine Versus Dolutegravir, Lamivudine, and Abacavir in a Real-Life Cohort of HIV-Infected Adults

2021 ◽  
pp. 106002802110341
Author(s):  
Inés Mendoza ◽  
Alicia Lázaro ◽  
Miguel Torralba
Keyword(s):  
Viral Load ◽  
Safety Profile ◽  
Real Life ◽  
Hazard Ratio ◽  
Treatment Discontinuation ◽  
Treatment Naïve ◽  
Tn 4 ◽  
Risk Of Treatment ◽  
Hiv 1 ◽  
All Treatment

Background: Dolutegravir (DTG) plus lamivudine (2-DR) is suggested as an initial and switch option in HIV-1 treatment. Objective: To analyze the effectiveness, durability, and safety of 2-DR compared with DTG plus abacavir/lamivudine (3-DR). Methods: This was an observational, ambispective study that included all treatment-naïve (TN) and treatment-experienced (TE) patients who started 2-DR or 3-DR between July 1, 2018, and November 30, 2020. The primary end point was noninferiority, at 24 and 48 weeks, of 2-DR versus 3-DR regarding the percentage of patients with viral load (VL)≥50 and 200 copies/mL in TN (4% margin) and VL<50 and 200 copies/mL in TE (margin 12%). Durability of response, and safety were also measured. Results: 242 patients were included (53 TN and 189 TE). Two TN patients on 2-DR had VL≥50 copies/mL and 1 had VL≥200 copies/mL at week 24. In TE patients on 2-DR, 90.2% achieved VL<200 copies/mL at week 24 (difference: 3.8%; 95% CI = −6.3% to 14%) and 91.8% at week 48 (difference: 0.06%; 95% CI = −9% to 10%), meeting noninferiority criteria. Among the 53 TN patients, only 1 VF was observed in 2-DR. In TN patients, the risk of treatment discontinuation was similar between groups (hazard ratio [HR] = 0.37; P = 0.15); similar rates were also found in TE patients (HR = 0.94; P = 0.85). TE patients on 2-DR showed a better safety profile compared with 3-DR patients ( P<0.001). Conclusion and Relevance: Our results did not show noninferiority in terms of virological effectiveness. Nevertheless, all effectiveness measures support the use of 2-DR in a real-life cohort of TN and TE. Additionally, durability and safety of 2-DR were confirmed to be similar to that of 3-DR.

scholarly journals STING and cGAS gene expressions were downregulated among HIV-1-infected persons after antiretroviral therapy

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Lorena Leticia Peixoto de Lima ◽  
Allysson Quintino Tenório de Oliveira ◽  
Tuane Carolina Ferreira Moura ◽  
Ednelza da Silva Graça Amoras ◽  
Sandra Souza Lima ◽  
...  
Keyword(s):  
Gene Expression ◽  
Viral Load ◽  
T Cell ◽  
Antiretroviral Therapy ◽  
Cell Count ◽  
Enzyme Linked Immunosorbent Assay ◽  
Type I ◽  
Α Level ◽  
The Impact ◽  
Hiv 1

Abstract Background The HIV-1 epidemic is still considered a global public health problem, but great advances have been made in fighting it by antiretroviral therapy (ART). ART has a considerable impact on viral replication and host immunity. The production of type I interferon (IFN) is key to the innate immune response to viral infections. The STING and cGAS proteins have proven roles in the antiviral cascade. The present study aimed to evaluate the impact of ART on innate immunity, which was represented by STING and cGAS gene expression and plasma IFN-α level. Methods This cohort study evaluated a group of 33 individuals who were initially naïve to therapy and who were treated at a reference center and reassessed 12 months after starting ART. Gene expression levels and viral load were evaluated by real-time PCR, CD4+ and CD8+ T lymphocyte counts by flow cytometry, and IFN-α level by enzyme-linked immunosorbent assay. Results From before to after ART, the CD4+ T cell count and the CD4+/CD8+ ratio significantly increased (p < 0.0001), the CD8+ T cell count slightly decreased, and viral load decreased to undetectable levels in most of the group (84.85%). The expression of STING and cGAS significantly decreased (p = 0.0034 and p = 0.0001, respectively) after the use of ART, but IFN-α did not (p = 0.1558). Among the markers evaluated, the only markers that showed a correlation with each other were STING and CD4+ T at the time of the first collection. Conclusions ART provided immune recovery and viral suppression to the studied group and indirectly downregulated the STING and cGAS genes. In contrast, ART did not influence IFN-α. The expression of STING and cGAS was not correlated with the plasma level of IFN-α, which suggests that there is another pathway regulating this cytokine in addition to the STING–cGAS pathway.

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