HIV Rapid Test Kits Research Articles

HIV self-testing in resource-limited settings: regulatory and policy considerations.

HIV self-testing (HIVST) is an emerging HIV testing strategy intended to address challenges of increasing access to preliminary knowledge of serostatus. It offers the potential for tests and testing to reach more people than previously possible, including those who do not seek testing in facilities. With approval of an HIV self-test kit in the USA, increasing evidence from public pilot programs in sub-Saharan Africa showing high acceptability and feasibility, and evidence of the informal sale of rapid HIV test kits in the private sector, options for individuals to access HIV self-testing, as well as consumer-demand, appear to be increasing. More recently WHO and UNAIDS have explored self-testing as an option to achieving greater HIV testing coverage to support global treatment targets. However, for resource-limited settings, technological development, diagnostic device regulation and quality assurance policies are lagging behind. This commentary will examine regulatory and policy issues with HIVST, given its increased prominence as a potential part of the global HIV/AIDS response.

Misdiagnosis of malaria using wrong buffer substitutes for rapid diagnostic tests in poor resource setting in Enugu, southeast Nigeria.

A key to the effective management of malaria is prompt and accurate diagnosis, and the use of malaria rapid diagnostic tests (mRDTs) is becoming relevant in the absence of reliable microscopy. This study explored the phenomenon of using the wrong buffer vial (often a kit from another brand or buffer from HIV rapid test kits), dextrose, saline or distilled water among health care providers who used RDTs for malaria diagnosis in resource poor settings in Enugu South East, Nigeria. Laboratory personnel (medical laboratory scientists, technicians, assistants, nurses, community health extension workers (CHEW), community health officers (CHO) and doctors) were interviewed using structured questionnaires and results were checked using the SOP checklist. The selection criterion was a prior experience with using RDTs, and any facility that did not use RDTs was excluded. Of the 80 study participants that completed their questionnaires, 56.3% reported that malaria diagnosis was positive using non-buffer RDTs detection while others reported negative results. Among the various professionals who used RDTs, 76.2% reported to have run out of RDT buffer stock at least once. Of the study participants that ran out of RDT buffer solution, 73% declared to have used non-RDT alternatives (physiological saline, 0.9% NaCl), distilled water, HIV buffer or ordinary water). Only 30% had received formal training on the proper usage and application of RDTs while 70% had never received any formal training on RDTs but learnt the technique of using RDT on the job. This study demonstrated that at least three quarters of health care workers in a resource poor setting had run out of buffer when using malaria RDTs and that the majority of them had used buffer substitutes, which are known to generate inaccurate tests results. This has the consequence of misdiagnosis, thus potentially damaging the credibility of malaria control.

Long-term highly suppressed HIV-infected children and adolescents with negative rapid HIV tests due to significant antibody loss

BackgroundRapid HIV test devices are widely used throughout the world and are important as diagnostic tools with relatively high sensitivity and specificity. Loss of HIV specific antibodies in late-stage AIDS patients has previously been reported in patients with advanced disease (i.e., AIDS). ObjectiveTo study rate of antibody loss that may lead to false negative HIV-antibodies results in children and adolescents who received long term antiretroviral (ARV) treatment with persistently undetectable viral loads. Study designFive FDA approved rapid HIV test kits including Trinity Uni-Gold Recombigen HIV-1, OraQuick Advance HIV-1/2, Reveal G3 HIV-1, Clearview STAT-PAK HIV-1/2, and Clearview COMPLETE HIV-1/2 were used to test 98 stored samples from 27 patients. Samples were tested at baseline and at least twice in 6–14 years post initiation of ARV treatment and full viral load suppression. ResultsOf the 403 tests, 43 (10.7%) were found to be false-negative using rapid HIV kits. Loss of positivity was correlated with decrease of HIV antibody titer. ConclusionsThere is a slow but persistent loss of HIV specific antibodies in highly suppressed HIV infected children and adolescents that may lead to false-negative results in rapid HIV antibody tests. The temporal loss of signal is dependent on the baseline level of antibodies and the type of HIV rapid test kit used.

Prevalence and Determinants of HIV among Symptomatic STI Cases in Southern Nations, Nationalities and People’s Regional States, Ethiopia

Background: Recognition of HIV/STI co infection has tremendous contribution for targeted intervention. Sexually transmitted infections have far reaching health, social and economic consequences. Sexually transmitted infections are very important because of their potential complication and interaction with HIV/AIDS. By evaluating the HIV/STI co infection it will be a signal to know the affected groups and major determinants. In doing so, the study finding would help in the planning, resource allocation and designed targeted prevention and control program. Objective: To determine the prevalence and determinants of HIV among symptomatic STI cases. Methods: Cross-sectional survey was conducted for HIV Sero prevalence and determinants among 415 symptomatic new STI cases that had been attended for treatment in eight hospitals in SNNPR, Ethiopia from November, 2011 to February, 2012. Standard rapid HIV antibody test was used to screen the sample blood following the national rapid HIV testing algorithm. Results: The overall HIV sero positivity was found to be 10.6%. Among 415 samples 371(89.4%) were negative and 44(10.6%) turned out to be positive.( Table 4) The rate varies among the major STI syndromes, namely, Urethral discharge syndrome (18.2%), vaginal discharge syndrome (56.8%), genital ulcer syndrome (15.9%), and lower abdominal pain (9.1%). (Table 4)Limitation of the study: Limitation of this study is the use of rapid HIV test kits which fails to detect recent infection. Moreover, the study is hospital based it can't be representative of the whole population, Conclusion and Recommendation: High prevalence of HIV in STI patients is explained by the role of STI in predisposing for HIV transmission which offers a unique opportunity for strengthening the prevention of HIV/STI co infection putting in place routine HIV test. Furthermore, public health intervention on consistent condom use and partner notification and referral should be given due emphasis targeted to the most at risk population.

P3.213 Seroprevalence of Human Immunodeficiency Virus (HIV) Infection Among Tuberculosis Patients Attending TB/DOTS Centre in Nnewi

BackgroundTB and HIV co-epidemic is a major public health problem in many parts of the world, particularly in developing counties. This study was a prospective cohort design to determine the...

P5.026 More Than Just Selling the Test: Pharmacist Opinion About the Sale of Over the Counter HIV Rapid Tests

Community pharmacy sale of over-the-counter (OTC) rapid HIV tests may provide an important extension of the public health system. U.S. pharmacy practise has expanded to include several public health services;...

Evaluation of current rapid HIV test algorithms in Rakai, Uganda

Rapid HIV tests are a crucial component of HIV diagnosis in resource limited settings. In Uganda, the Ministry of Health allows both serial and parallel HIV rapid testing using Determine, Stat-Pak and Uni-Gold. In serial testing, a non-reactive result on Determine ends testing. The performance of serial and parallel algorithms with Determine and Stat-Pak test kits was assessed. A cross-sectional diagnostic test accuracy evaluation using three rapid HIV test kits as per the recommended parallel test algorithm was followed by EIA-WB testing with estimates of the performance of serial testing algorithm. In 2520 participants tested by parallel rapid algorithms, 0.6% had weakly reactive result. Parallel testing had 99.7% sensitivity and 99.8% specificity. If Stat-Pak was used as the first screening test for a serial algorithm, the sensitivity was 99.6% and specificity was 99.7%. However, if Determine was used as the screening test, sensitivity was 97.3% and specificity was 99.9%. Serial testing with Stat-Pak as the initial screening test performed as well as parallel testing, but Determine was a less sensitive screen. Serial testing could be cost saving.

ST107 Suitability and Approval of HIV Rapid Test Kits after Arrival In-Country

The suitability of rapid HIV test kits for use in resource-limited countries has been challenged. This includes the provision of inferior kits by manufacturers, compromised test kits when they arrive in-country, and damaged kits when they reach the end user. For the past 2 years, we have been working with the Partnership for Supply Chain Management to provide assistance in addressing these issues for rapid test kits. Thus far, our evaluations have been directed to assessing test kits for their performance characteristics once they have arrived in-country. At the in-country warehouse, before distribution to the laboratories, a sample of kit lots were sent to our laboratory to assess their suitability. For HIV rapid kits, we have evaluated >150 and found several concerns. In Africa, we were faced with a situation where several lots of an HIV test kit passed our evaluation, but failed an evaluation in the country’s National Reference Laboratory. Subsequently, the country refused to allow these lots of kits to be used, resulting in thousands of test kits being quarantined and causing an enormous economic concern for the purchaser of these kits. Subsequently, both our laboratory and the CDC re-evaluated these lots and again found them to be suitable for use. Finally, one of our staff was sent to this country to evaluate the capabilities at the National Reference Laboratory and perform another evaluation on these kit lots in-country. The kits, again, passed, and recommendations were provided to the Reference Laboratory. This project highlights the need to assess the suitability of rapid test kits in Africa and the need for continuous monitoring of all aspects to prevent negative economic consequences.

Does Pre-Survey Training Impact Knowledge of Survey Administrators and Survey Outcomes in Developing Countries? Evaluation Findings of a Training of Trainers Workshop for National AIDS and Reproductive Health Survey-Plus in Nigeria.

Although, Nigeria had conducted various national surveys followed by central and state level trainings for survey administrators, prior pre-survey trainings have not been systematically evaluated to assess their impact on knowledge gain and final outcome of the survey. A central training of trainers' session was organized for master trainers on the conduct of the 2012 National AIDS and Reproductive Health Survey. To evaluate the impact of training on the quality of conduct of a national research survey in the 36 states and the Federal Capital Territory in Nigeria. A total of 185 participants consisting of State AIDS Program Coordinators, Reproductive Health Coordinators, State Laboratory Scientists, Lead Supervisors and Counselor Testers were invited from the 36 states in Nigeria and the FCT for the central training of trainers in Abuja. The training lasted 5 days and the trainees were grouped into two on the basis of behavioral epidemiology and laboratory components. Training tools such as the developed protocol, training power point slides, practical sessions such as role plays, and usage of HIV rapid test kits were utilized during the training. The facilitators were drawn from Federal Ministry of Health (FMoH), universities and research Institutions as well as Non-Governmental Organizations (NGOs). The facilitators prepared and administered 25 structured questions for the behavioral group and 28 questions for the laboratory group at the beginning of the training to assess the participants' knowledge of HIV and the survey. The same questions answered by Trainees responded to the same questions prior to the commencement and at the end of the trainings. Scores were aggregated to 100 for each test. We conducted paired t-test to determine statistically significant differences between pre-test and post-test results at 0.05 significance level and ANOVA to determine if there were differences in knowledge level among different groups. The overall mean pre-test and post-test scores were 64.0% and 77.4% respectively indicating a 13.4% knowledge gain above what it was at the beginning of the training. The mean pre-test score and post-test score for the Southern states (SN) were 64.7% and 80.3% while that of the Northern states (NN) were 63.5% and 75.3% representing a knowledge gain of 15.6% and 11.8% respectively. There was statistical significant difference in the post-test scores between the two regions (p=0.001) and in knowledge gained after the training (p=0.017). Comparison between the pre test and post test scores at the 5-day training showed a significant gain in knowledge of participants. The survey training contributed positively to the preparation and building of knowledge needed for the conduct of 2012 NARHS-plus.

Feasibility of testing antibodies to HIV from filter paper using HIV rapid test kits

7‐11 November 2010, Tenth International Congress on Drug Therapy in HIV Infection, Glasgow, UK

Avaliação do grau de implantação do programa de controle da transmissão vertical do HIV em maternidades do "Projeto Nascer": Implementation evaluation of Brazil's National vertical HIV transmission control program in maternity clinics participating in the "Nascer" Project

OBJECTIVE: to evaluate the implementation of the National Control Program of HIV Vertical Transmission in brazilian maternities. METHODOLOGY: data from medical records, interview with pregnant women and pre-birth care observation were compared to a retrospective cohort of positively diagnosed pregnant women from the same maternity clinics. RESULTS: sixty-seven percent out of 30 clinics had rapid HIV test kits and IV and syrup AZT. In 324 cohort pregnant women previously diagnosed for HIV, 18% had not taken AZT and 7% have not had their children medicated. CONCLUSION: unavailability of human resources, rapid HIV test kits, inappropriate conditions for testing and lack of HIV counseling and testing for pregnant women were major negative findings.

Final evaluation results for the Fast-Check HIV rapid test kits

In late April 2002, the British Columbia Centre for Disease Control (BCCDC) reported to Health Canada potential problems with the Fast-Check HIV-1/2 point-of-care whole blood (POC WB) test (BioChem ImmunoSystems). On the basis of these data, Health Canada issued a safety advisory,[1][1] and the test

Sensitivity and specificity of rapid HIV testing of pregnant women in India.

Efforts to prevent HIV transmission from mother to infants in settings like India may benefit from the availability of reliable methods for rapid and simple HIV screening. Data from India on the reliability of rapid HIV test kits are limited and there are no data on the use of rapid HIV tests for screening of pregnant women. Pregnant women attending an antenatal clinic and delivery room in Pune agreed to participate in an evaluation of five rapid HIV tests, including (a) a saliva brush test (Oraquick HIV-1/2, Orasure Technologies Inc.), (b) a rapid plasma test (Oraquick HIV-1/2) and (c) three rapid finger prick tests (Oraquick HIV-1/2; HIV-1/2 Determine, Abbott; NEVA HIV-1/2 Cadila). Results of the rapid tests were compared with three commercial plasma enzyme immunoassay (EIA) tests (Innotest HIV AB EIA, Lab systems/ELISCAN HIV AB EIA, UBI HIV Ab EIA). Between September 2000 and October 1, 2001, 1258 pregnant women were screened for HIV using these rapid tests. Forty-four (3.49%) of the specimens were HIV-antibody-positive by at least two plasma EIA tests. All of the rapid HIV tests demonstrated excellent specificity (96-100%). The sensitivity of the rapid tests ranged from 75-94%. The combined sensitivity and specificity of a two-step algorithm for rapid HIV testing was excellent for a number of combinations of the five rapid finger stick tests. In this relatively low HIV prevalence population of pregnant women in India, the sensitivity of the rapid HIV tests varied, when compared to a dual EIA algorithm. In general, the specificity of all the rapid tests was excellent, with very few false positive HIV tests. Based upon these data, two different rapid HIV tests for screening pregnant women in India would be highly sensitive, with excellent specificity to reliably prevent inappropriate use of antiretroviral therapy for prevention of vertical HIV transmission.