scholarly journals Usability and Clinical Performance Characteristics of the Asante HIV1/2 Test by Trained Users in Two African Sites

Diagnostics ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. 1727
Author(s):  
Mohammed Majam ◽  
Naleni Rhagnath ◽  
Vanessa Msolomba ◽  
Leanne Singh ◽  
Michael S. Urdea ◽  
...  
Keyword(s):  
South Africa ◽  
Clinical Performance ◽  
Linkage To Care ◽  
High Sensitivity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Hiv Diagnosis ◽  
Hiv Test ◽  
Catchment Areas ◽  
Sensitivity Specificity ◽  
Hiv 1

HIV self-testing (HIVST) devices are acknowledged as having the potential to enable the acceleration of HIV diagnosis and linkage to care. How efficiently professional and trained users engaged with the Asante HIV-1/2 Oral Self-Test (Asante) (Sedia Biosciences, Portland, OR, USA), and the accuracy of the device in comparison to other HIV rapid diagnostic tests (RDT), was assessed to be able to guide the development and adoption of the device in Senegal and South Africa. Using convenience sampling, potential participants were recruited from catchment areas where HIV was prevalent. Trained users performed an HIV test on participants using an Oral HIVST. The professional user’s interpretation of results was then measured against the results of various other RDTs. The South African study had 1652 participants and the Senegalese, 500. Most of the participants in each study were 18–35 years old. Senegal had a higher number of females (346/500, 69.2%) compared to South Africa (699/1662, 42.1%). Asante displayed very high sensitivity and specificity when tested against other devices. In the final enzyme-linked immunosorbent assay (ELISA) comparison, in South Africa, the sensitivity: specificity was 99.1:99.9% and in Senegal, 98.4:100.0%. Senegal further identified 53/63 (84.1%) with HIV-1, 8/63 (12.7) with HIV-2 and 2/63 (3.2%) with HIV-1/2 co-infections. Professional or trained users’ interpretations of Asante results correlated strongly to results when using various RDTs, the ELISA assay and Western blot tests, making it a dependable HIV testing instrument.

scholarly journals Yeni HIV Tanı Algoritmasına Geçiş Sürecinde Ulusal HIV-AIDS Referans Merkezi’nin Deneyimi: Line-İmmunoassay Test ve Bio-Rad Geenius™ HIV-1/2 Antikor Ayırt Edici Hızlı Doğrulama Testleri Karşılaştırmalı Analizi

2021 ◽  
Vol 55 (1) ◽  
pp. 17-29
Author(s):  
Tülin Demir ◽  
Dilara Yıldıran ◽  
Selçuk Kılıç
Keyword(s):  
Viral Hepatitis ◽  
Enzyme Linked Immunosorbent Assay ◽  
Hiv Positive ◽  
Rt Pcr ◽  
Hiv Diagnosis ◽  
Proviral Dna ◽  
Confirmatory Tests ◽  
Sensitivity Specificity ◽  
Hiv 1 ◽  
Hiv Aids

Shortly after the first detection of human immundeficiency virus (HIV) infection in USA in 1981, the number of cases have increased gradually from all around the world. Turkey’s high capacity for tourism and the unique geographic location extending between Europe and Asia, provides convenience for the passage of individuals across the countries and sexually transmitted infections including HIV, as well. According to the official data of the Ministry of Health; there are 25809 HIV positive and 1958 AIDS cases as of November 30, 2020, after the epidemic started in 1985 in Turkey. Despite the decrease in the number of newly detected HIV cases as a result of serious measures taken for the transmission of infection worldwide, the increase in the number of cases still continues in our country. Shortening the reporting period and starting treatment as soon as possible in the diagnosis of infection is critical for the control of the epidemic. For this purpose, Centers for Disease Control and Prevention (CDC) published a new test algorithm in 2010, which suggested the use of the Geenius™ HIV ½ supplemental assay test instead of western blot tests, which have been used for many years to verify HIV screening test positivity. In this study, we aimed to report the experience of the National HIV-Acquiner Immundeficiency Syndrome (AIDS) and Viral Hepatitis Reference Laboratories of Turkey in the first year of transition to the new HIV algorithm and to evaluate the diagnostic performance of Geenius™ HIV ½ and line immunassay (LIA) s. A total of 2090 anti-HIV positive patient sera sent to National HIV-AIDS and Viral Hepatitis Reference Laboratories of Turkey, Ankara for HIV confirmation were included in the study. All samples were retested with a fourth-generation enzyme linked immunosorbent assay (ELISA) test (VIDAS® HIV-1/2 Duo Ultra assay, BioMerieux, France) followed by the confirmatory tests; Geenius™ HIV 1/2 confirmatory assay (BioRad, Redmond, WA) and Line-immunoassay (INNO-LIA HIV ½ Score, Fujirebio, Belgium). Indeterminate/negative test results or discrepancies between the confirmatory tests were resolved with HIV-1 RNA reverse transcriptase polymerase chain reaction (RT-PCR) (artus HI Virus-1 RT-PCR, Qiagen, Germany) test and in-house HIV-2 RNA and proviral DNA PCR. The sensitivity, specificity, and the agreement of the each assay were compared. Cohen’s Kappa analysis was used for the evaluation of the agreement between the tests. According to the new algorithm which recommended Geenius™ test besides HIV-1 RNA test, 1707 (81.7%) HIV-1 positive samples were identified. Of these samples; 95.9% and 95.02% were identified as HIV-1 positive by GeeniusTM and INNO-LIA, respectively. However, 2.5% of the positive samples were negative with Geenius™ and 3.5% with INNO-LIA. One and a half percentage (1.5%) of these samples were detected with Geenius™ and 1.4% with INNO-LIA as indeterminant. When all the positive samples determined with ELISA were evaluated; it was detected that,1.3% were indeterminate by Geenius™ test and 2.4% by the INNO-LIA test. When the INNO-LIA test was regarded as the gold standard method; sensitivity, specificity, positive predictive and negative predictive values of the Geenius™ test were as follows; 99.7%, 96.1%, 98.9%, and 99.1%. The agreement between INNO-LIA and Geenius™ tests was found to be 98.95% (κ= 0.969; very good). When the Geenius™ and HIV-1 PCR tests were evaluated together for the confirmation; the sensitivities of Geenius™ and INNO-LIA tests were 99.8% and 98.3%, specificities were 89.8% and 85.3%, respectively. Slight positive bands were detected in the gp36 or gp140 bands, the HIV-2 specific envelope proteins, were detected in seven samples, However, the positivity disappeared after the dilution of the samples and it was accepted as false positivite reaction due to the absence of HIV-2 RNA and proviral DNA in these samples. In conclusion; we concluded that Geenius™ and INNO-LIA tests have a perfect agreement in HIV diagnosis and due to the rapid and reliable results provided for the HIV test protocol, Geenius™ test can be used safely as an alternative to the immunoblot tests. HIV-1 RNA testing must be performed in all HIV confirmation centers in order to detect acute HIV cases in the fast and early period which are the main reason for the updates in HIV diagnosis.

scholarly journals Evaluation of the Aptima HIV-1 Quant Dx assay for HIV diagnosis at birth in South Africa

2021 ◽  
pp. 115467
Author(s):  
Aurélie Mukendi ◽  
Tendesayi Kufa ◽  
Gayle G Sherman ◽  
Karl-Günter Technau ◽  
Caroline T Tiemessen ◽  
...  
Keyword(s):  
South Africa ◽  
Hiv Diagnosis ◽  
Hiv 1

"Sandwich" enzyme immunoassay for placental alkaline phosphatase.

1981 ◽  
Vol 27 (12) ◽  
pp. 2014-2018 ◽  
Author(s):  
J L Millán ◽  
T Stigbrand
Keyword(s):  
Alkaline Phosphatase ◽  
Rheumatoid Factor ◽  
Cancer Patients ◽  
High Sensitivity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Placental Alkaline Phosphatase ◽  
Upper Limit ◽  
Highly Sensitive ◽  
Sensitivity Specificity ◽  
Sandwich Enzyme Immunoassay

Abstract Alkaline phosphatase of the placental type in serum has been suggested as a "marker" for malignancy and pregnancy. We describe a highly sensitive enzyme-linked immunosorbent assay (ELISA) for the measurement of this enzyme in serum and ascitic fluid. The assay will detect as little as 0.4 microgram/L, significantly less than with a radioimmunoassay performed with the same reagents. It is highly specific; it does not measure even above-normal concentrations of the intestinal and liver isoenzymes of alkaline phosphatase. The assay is technically simple and allows the processing of many samples in less than 10 h. We measured this isoenzyme in serum of an adult control population. The upper limit of normality is 1.85 microgram/L. Interference by rheumatoid factor was eliminated. Concentrations of the analyte were increased in all pregnancy sera tested. Concentration and activity as measured by two different catalytic assays correlated well. Samples from cancer patients also showed a good correlation, with some exceptions. Possible reasons for these exceptions are discussed. The high sensitivity, specificity, and simplicity of this assay should make it a useful adjunct in monitoring cancer and pregnancy.

scholarly journals Early HIV Diagnosis Leads to Significantly Decreased Costs in the First 2 Years of HIV Care in an Urban Charity Hospital in New Orleans

2017 ◽  
Vol 16 (6) ◽  
pp. 527-530 ◽  
Author(s):  
Jason Halperin ◽  
Morgan Katz ◽  
Ishani Pathmanathan ◽  
Leann Myers ◽  
Nicholas Van Sickels ◽  
...  
Keyword(s):  
Linkage To Care ◽  
Hiv Care ◽  
Newly Diagnosed ◽  
Inclusion Criteria ◽  
Hiv Diagnosis ◽  
Total Cost ◽  
Hiv Rna ◽  
Charity Hospital ◽  
Median Total Cost ◽  
Hiv Test

We undertook a retrospective cohort study of patients with a positive HIV test in the emergency department who were then linked to care. Inpatient, outpatient, and emergency costs were collected for the first 2 years after HIV diagnosis. Fifty-six patients met the inclusion criteria; they were predominantly uninsured (73%) and African American (89%). The median total cost for a newly diagnosed patient over the first 2 years was US$36 808, driven predominantly by outpatient costs of US$17 512. Median inpatient and total costs were significantly different between the lowest (<200 cells/mm3) and highest (>499 cells/mm3) CD4 count categories (US$21 878 vs US$6607, P <.05; US$61 378 vs US$18 837, P <.05, respectively). Total costs were significantly different between viral load categories <100 000 HIV-RNA copies/mL and ≥100 000 HIV-RNA copies/mL (US$28 219 vs US$49 482, P <.05). Costs were significantly lower among patients diagnosed earlier in their disease. Decreased cost is another factor supporting early diagnosis and linkage to care for patients with HIV.

scholarly journals Seroprevalence and characterisation of herpes simplex virus from human immunodeficiency virus in samples collected from two provinces in South Africa: a retrospective study

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 105
Author(s):  
Oluwafemi Samuel Obisesan ◽  
Nomathamsanqa Patricia Sithebe ◽  
Hazel Tumelo Mufhandu
Keyword(s):  
South Africa ◽  
Herpes Simplex Virus ◽  
Herpes Simplex ◽  
Goodness Of Fit ◽  
High Rate ◽  
Enzyme Linked Immunosorbent Assay ◽  
Goodness Of Fit Test ◽  
Simplex Virus ◽  
Hiv 1 ◽  
Hsv 1

Background: Herpes simplex virus (HSV) is a widely distributed human pathogen that is known for its ulcerative lesions at the infection site. HSV can cause persistent infection in the host that is often followed by a period of latency within the neurons. Considering the high rate of HIV infection in South Africa, it is important to assess the seroprevalence of HSV with a focus to determine the epidemiological association between HSV-DNA and HIV-1 in the population. Methods: A total of 44 sera samples were screened for HSV and HIV-1 using the highly sensitive enzyme-linked immunosorbent assay (ELISA). The ELISA positive samples were characterized using polymerase chain reaction (PCR) to confirm the positivity of both viruses and to further differentiate HSV into HSV-1 and -2. Thereafter, the samples were analysed for relatedness using phylogenetic analysis. Results: Of the 44 samples, 36 (81.8%) were positive for HIV-1, while 35 (79.5%) were positive for HSV when screened with ELISA kits. The PCR results, with the use of type specific primers, showed that 4/35 (11.4%) samples were specific for HSV-1 while 30/35 (85.7%) were specific for HSV-2. Statistical analysis performed using the chi-squared goodness-of-fit test showed that there is a significant relationship between HSV-2 and HIV-1 transmission. Conclusions: The prevalence of HSV in the population is high with an increased HSV-2 infection in women. Our study shows that some of the HSV-2 isolates are not related to the clinical isolate SD90e from South Africa, suggesting diversity in HSV-2 viral transmission.

scholarly journals Evaluation and Diagnostic Usefulness of Domestic and Imported Enzyme-Linked Immunosorbent Assays for Detection of Human Immunodeficiency Virus Type 1 Antibody in India

2005 ◽  
Vol 12 (12) ◽  
pp. 1425-1428 ◽  
Author(s):  
H. Syed Iqbal ◽  
Suniti Solomon ◽  
K. G. Murugavel ◽  
Sunil Suhas Solomon ◽  
P. Balakrishnan
Keyword(s):  
Human Immunodeficiency Virus ◽  
False Negative ◽  
Confirmatory Test ◽  
Enzyme Linked Immunosorbent Assay ◽  
Antibody Testing ◽  
Negative Results ◽  
Hiv Test ◽  
Immunodeficiency Virus ◽  
Hiv Antibodies ◽  
Hiv 1

ABSTRACT Diagnosis of human immunodeficiency virus (HIV) infection is important for patient management and prevention of new infections. The number of test kits available for the detection of HIV antibodies is unprecedented. In order to identify appropriate test kits, we evaluated a variety of commercial kits manufactured abroad as well as in India. The plasma and serum specimens (n = 264) were collected from individuals attending the Voluntary Counseling and Testing Centre at the YRG Centre for AIDS and Education. The specimens were used to evaluate six commercially available HIV test kits: Enzaids HIV 1+2, HIV-CheX, Murex HIV-1.2.0, Genscreen HIV 1/2 version 2, Vironostika HIV Uni-Form II Ag/Ab, and CombAids RS Advantage. High sensitivities and specificities (≥99%) were observed for the Enzaids, Murex, Vironostika, and CombAids assays. HIV-CheX showed the highest number of false-positive and false-negative results. The Genscreen test also gave many false positives. The study indicated that the Enzaids, Murex, and Vironostika enzyme-linked immunosorbent assay kits and the CombAids RS Advantage rapid assay could be used to achieve acceptable results for the detection of HIV antibodies. A combination of two tests is recommended to optimize the efficiency of HIV antibody testing algorithms, especially when evaluation with an HIV Western blot confirmatory test is not possible.

scholarly journals Field Evaluation of Performance of Alere and Cepheid Qualitative HIV Assays for Pediatric Point-of-Care Testing in an Academic Hospital in Soweto, South Africa

2017 ◽  
Vol 55 (11) ◽  
pp. 3227-3235 ◽  
Author(s):  
Tanya Y. Murray ◽  
Gayle G. Sherman ◽  
Firdose Nakwa ◽  
William B. MacLeod ◽  
Nosisa Sipambo ◽  
...  
Keyword(s):  
South Africa ◽  
Hiv Testing ◽  
Point Of Care ◽  
Standard Of Care ◽  
Field Evaluation ◽  
Hospital Environment ◽  
Current Standard ◽  
Hiv Diagnosis ◽  
Treatment Naïve ◽  
Sensitivity Specificity

ABSTRACTPoint-of-care (POC) technologies for HIV diagnosis in infants have the potential to overcome logistical challenges that delay treatment initiation and prevent improvements in morbidity and mortality. This study aimed to evaluate the performance of two POC technologies against the current standard-of-care (SOC) laboratory-based assay in South Africa, when operated by nurses in a hospital environment. Children <18 months of age who were treatment naive (excluding prophylaxis) and in whom an HIV PCR test was indicated were eligible for the study. To increase the rate of enrollment of HIV PCR-positive children, HIV-exposed neonates at high risk of mother-to-child transmission and children requiring confirmatory HIV testing were preferentially enrolled. The two POC technologies demonstrated excellent concordance, with 315 (97.8%) results consistent with the SOC result. The POC technologies yielded 102 positive and 220 negative tests each. The SOC assay had 101 positive, 214 negative, 4 indeterminate, 1 invalid, and 2 specimen-rejected results. To include the indeterminate results in sensitivity/specificity calculations, a sensitivity analysis was performed, which yielded a simulated sensitivity of 0.9904 (interquartile range [IQR], 0.9808 to 0.9904) and a specificity of 0.9954 (IQR, 0.9954 to 1.0). This study confirmed that both POC technologies can be successfully used outside the laboratory environment to yield precise sensitivity/specificity values for pediatric, including neonatal, HIV testing.

scholarly journals Seroprevalence and characterisation of herpes simplex virus from human immunodeficiency virus in samples collected from two provinces in South Africa: a retrospective study

F1000Research ◽  
2021 ◽  
Vol 10 ◽  
pp. 105
Author(s):  
Oluwafemi Samuel Obisesan ◽  
Nomathamsanqa Patricia Sithebe ◽  
Hazel Tumelo Mufhandu
Keyword(s):  
South Africa ◽  
Herpes Simplex Virus ◽  
Herpes Simplex ◽  
Goodness Of Fit ◽  
High Rate ◽  
Enzyme Linked Immunosorbent Assay ◽  
Goodness Of Fit Test ◽  
Simplex Virus ◽  
Hiv 1 ◽  
Hsv 1

Background: Herpes simplex virus (HSV) is a widely distributed human pathogen that is known for its ulcerative lesions at the infection site. HSV can cause persistent infection in the host that is often followed by a period of latency within the neurons. Considering the high rate of HIV infection in South Africa, it is important to assess the seroprevalence of HSV with a focus to determine the epidemiological association between HSV-DNA and HIV-1 in the population. Methods: A total of 44 sera samples were screened for HSV and HIV-1 using the highly sensitive enzyme-linked immunosorbent assay (ELISA). The ELISA positive samples were characterized using polymerase chain reaction (PCR) to confirm the positivity of both viruses and to further differentiate HSV into HSV-1 and -2. Thereafter, the samples were analysed for relatedness using phylogenetic analysis. Results: Of the 44 samples, 36 (81.8%) were positive for HIV-1, while 35 (79.5%) were positive for HSV when screened with ELISA kits. The PCR results, with the use of type specific primers, showed that 4/35 (11.4%) samples were specific for HSV-1 while 30/35 (85.7%) were specific for HSV-2. Statistical analysis performed using the chi-squared goodness-of-fit test showed that there is a significant relationship between HSV-2 and HIV-1 transmission. Conclusions: There is a significant positive association between HSV-2 and HIV-1 in the study population. Our study shows that some of the HSV-2 isolates are not related to the clinical isolate SD90e from South Africa, suggesting diversity in HSV-2 viral transmission.

scholarly journals Upregulated Serum MiR-146b Serves as a Biomarker for Acute Ischemic Stroke

2018 ◽  
Vol 45 (1) ◽  
pp. 397-405 ◽  
Author(s):  
Zhenzhen Chen ◽  
Kaihua Wang ◽  
Jianmin Huang ◽  
Guangshan Zheng ◽  
Yan Lv ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Infarct Volume ◽  
High Sensitivity ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
High Morbidity ◽  
Potential Biomarker ◽  
Hs Crp ◽  
Sensitivity Specificity

Background/Aims: Stroke is a major cerebrovascular disease threatening human health and life with high morbidity, disability and mortality. It is aimed to find effective biomarkers for the early diagnosis on stroke. Methods: The expressions of 17 previously reported stroke-associated miRNAs were measured using quantitative RT-PCR and the expressions of plasma high-sensitivity C reactive protein (hs-CRP) and serum interleukin 6 (IL-6), the pro-inflammation markers in brain injury, were examined using enzyme-linked immunosorbent assay in 128 acute ischemic stroke (AIS) patients and control group. Results: Serum miR-146b expression was significantly increased within 24 hours after stroke onset in patients compared with control group. In addition, the upregulation of serum miR-146b was strong positively correlated with plasma hs-CRP, infarct volume and National Institutes of Health Stroke Scale (NIHSS) score, and moderate positively correlated with serum IL-6 of patients. Importantly, the combination of plasma hs-CRP and serum miR-146b gained a better sensitivity/specificity for prediction of AIS (AUC from 0.782 to 0.863). Conclusion: Our preliminary findings suggested that upregulated serum miR-146b in acute ischemic stroke might be a potential biomarker for AIS evaluation.

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