Dried tube specimens: A simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings

Parekh, Bharat; Anyanwu, Juliana; Patel, Hetal; Downer, Marie; Kalou, Mireille; Gichimu, Catherine; Keipkerich, Bera Steven; Clement, Nelly; Omondi, Michael; Mayer, Oren; Ou, Chin Yih; Nkengasong, John N.

doi:10.1016/j.jviromet.2009.10.013

Cited by 61 publications

(74 citation statements)

References 16 publications

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“…The study conducted by Parekh et al (10) , in which the participants described the DST method as simple to apply, are consistent with the perceptions of the HCWs interviewed in the present study, who also described it as simple to understand and perform.…”

Section: Discussionsupporting

confidence: 90%

“…The suggestions made by both HCWs and VCTC coordinators, as well as by the participants in the study by Parekh et al (10) , point to the need to expand the scope of the EQA-RT/DTS-HIV program to include other tests. In addition, these responses indicated a lack of periodicity in the delivery of the kits, as indicated at the training sessions; the need to train more than one HCW per VCTC; and the certifi cation of centers as further factors to improve the success of the program at VCTCs.…”

Section: Discussionmentioning

confidence: 99%

“…DTS panels are stable at room temperature and can offer reliable results even in the basic VCTCs located in the remote interiors of the Amazon, which is characterized by its extreme temperatures and high humidity (10) . In Tanzania, which has rural health facilities in similar conditions as those in the Amazon, using DTS for EQA gave rise to 99.5% agreement between DTS and the rapid HIV test results (11) .…”

Section: Methodsmentioning

confidence: 99%

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External quality assessment in the voluntary counseling and testing centers in the Brazilian Amazon using dried tube specimens: results of an effectiveness evaluation

Beber

Sabidó

Vieira

et al. 2015

Rev. Soc. Bras. Med. Trop.

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Revista da Sociedade Brasileira de Medicina Tropical 48(Suppl I):87-97, 2015http://dx.doi. org/10.1590/0037-8682-0106-2014 Major Article INTRODUCTION ABSTRACT Introduction:In 2011, the Brazilian Ministry of Health rolled out a program for the external quality assessment of rapid human immunodefi ciency virus (HIV) tests using the dried tube specimen (DTS) method (EQA-RT/DTS-HIV). Our objective was to evaluate the implementation of this program at 71 voluntary counseling and testing centers (VCTCs) in the Brazilian Legal Amazonian area one year after its introduction. Methods: Quantitative and qualitative study that analyzed secondary data and interviews with healthcare workers (HCWs) (n=39) and VCTC coordinators (n=32) were performed. The assessment used 18 key indicators to evaluate the three dimensions of the program's logical framework: structure, process, and result. Each indicator was scored from 1-4, and the aggregate results corresponding to the dimensions were expressed as proportions. The results were compared to the perceptions of the HCWs and coordinators regarding the EQA-RT/DTS-HIV program. Results: The aggregate scores for the three dimensions of structure, process, and result were 91.7%, 78.6%, and 95%, respectively. The lowest score in each dimension corresponded to a different indicator: access to Quali-TR online system 39% (structure), registration in Quali-TR online system 38.7% (process), and VCTC completed the full process in the program's fi rst round 63.4% (result). Approximately 36% of the HCWs and 52% of the coordinators reported enhanced trust in the program for its rapid HIV testing performance. Conclusions: All three program dimensions exhibited satisfactory results (>75%). Nevertheless, the study fi ndings highlight the need to improve certain program components. Additionally, long-term followups is needed to provide a more thorough picture of the process for external quality assessment.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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External quality assessment in the voluntary counseling and testing centers in the Brazilian Amazon using dried tube specimens: results of an effectiveness evaluation

Beber

Sabidó

Vieira

et al. 2015

Rev. Soc. Bras. Med. Trop.

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“…With growth come several challenges, including the high cost of shipping plasma specimens on dry ice. We are looking at alternative approaches, including dried blood, serum, or plasma spots (22) or dried tube specimens (20), which would significantly reduce shipping costs because these specimens can be shipped at room temperature. In addition, we are exploring the online submission of results, which should greatly improve data acquisition and analysis.…”

Section: Discussionmentioning

confidence: 99%

A Comprehensive Evaluation of the Proficiency Testing Program for the HIV-1 BED Incidence Assay

et al. 2011

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Analysis of controls and calibrator specimen for all 343 runs showed a coefficient of variation of ca. 20% for raw ODs in the dynamic range, which was reduced to <10% when the OD was normalized (OD-n). Most laboratories that failed the PT assessment had transcriptional errors, kit reagent problems, or specimen handling errors. Thus, the BED-specific PT program enabled us to track performance of different laboratories conducting the BED assay while identifying areas for improvements. This program will also serve as a template for future PT programs for new incidence assays as they become available.The HIV-1 BED Incidence EIA (BED assay) is an IgG capture enzyme immunoassay to detect and distinguish recent (Ͻ6 months) from long-term HIV-1 infection. This assay was developed to measure HIV-1 incidence for population surveillance (7, 23) and has been applied in worldwide settings (8,10,11,15,16,19,26). Although there are several reports of in-house assays (1, 24, 30) or modified diagnostic assays (4,13,14,17,18,25,28) to detect recent infections, the BED assay is the only assay developed specifically to detect recent HIV-1 infections for incidence estimation and commercially available as a kit. The number of laboratories using the BED assay has increased steadily. As with all laboratory testing, a comprehensive quality assurance (QA) program is a vital component of incidence testing. Quality of testing can be assured by multiple steps implemented at different levels that include training, monitoring, and corrective actions as part of the continuous quality improvement. The BED assay includes four kit control specimens, including one calibrator (CAL) specimen (7). Control specimens validate the runs, while CAL is used to normalize the optical density values which minimize inter-run variations. Because of the quantitative nature of the BED assay, it is critically important that the testing is performed with highest quality. Proficiency testing (PT) programs have been shown to be very effective in improving the quality of laboratory testing, including HIV testing (2, 3, 5, 6, 9, 12). The goals of PT for HIV incidence testing are to assess the performance of participating laboratories and to identify issues for corrective action and technical assistance. The Centers for Disease Control and Prevention (CDC) initiated a voluntary and cost-free PT program in 2006 with 12 participating laboratories and has expanded to more laboratories over time. We report here the results of this PT program, which provides information about precision and reproducibility of the BED assay among participating laboratories over seven rounds. MATERIALS AND METHODSSpecimens. The specimens chosen for each PT round were from a collection of 25 undiluted HIV-1-positive bulk volume donor plasma samples purchased from SeraCare Life Sciences, Inc. (Milford, MA). The donor plasma were heat inactivated at 56°C for 30 min, fully characterized using the HIV-1 BED Incidence Assay, and then divided into aliquots and stored at Ϫ70°C. Twenty-five specimens co...

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“…Kit protocols were strictly followed in carrying out the tests, and the technicians who performed these tests were well trained in the testing procedures and quality assurance principles, including the use of standardized registers (6). Proficiency panels of dried tube samples were provided twice during the study as external quality assessments for testers performing the rapid testing (11). In addition, sites were provided with positive and negative controls to be used as quality control specimens, which were routinely used to ensure kit performance.…”

mentioning

confidence: 99%

Field Evaluation of Four Rapid Tests for Diagnosis of HIV Infection in Panama

Juarez

Núñez²,

Aranda³

et al. 2016

J Clin Microbiol

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dFour HIV rapid tests were subjected to field validation in Panama and compared to an enzyme-linked immunosorbent assay/ Multispot-based testing algorithm. The sensitivities of Determine, Uni-Gold, SD Bioline, and INSTI were 99.8%. The specificities of Determine, SD-Bioline, and Uni-Gold were 100%, and the specificity of INSTI was 99.8%. On the basis of these data, we determined that these rapid tests can be used in an appropriate algorithm to diagnose HIV infection and are suitable for use in testing and counseling settings in Panama. Early diagnosis of HIV infection is important for prevention and patient management; delays in diagnosis of HIV infection represent a loss of opportunities for improving individual health and public health. The risk of transmitting the virus is higher if the patient does not know his/her status, does not reduce risk behaviors, and has a high viral load. The late start of treatment adversely affects the patient's prognosis, increasing morbidity and mortality (1). Several different assays are available for the detection of specific antibodies to diagnose HIV infection (2). Although the enzyme immunoassay (EIA) is most commonly used for diagnosis, the disadvantages of EIA are the need for well-trained technicians, appropriate equipment, laboratory infrastructure, and batch testing (3). In developing countries, such as those in Central America, technical support is not available in most of the peripheral primary care units (4-6). The number of samples screened per day is usually small, and the infrastructure and facilities for performing the EIA are not ideal or cost-effective. There is also a need to establish voluntary counseling and testing (VCT) facilities as part of the HIV infection prevention strategy. In these situations, tests need to be simple and rapid, reducing the time between infection and diagnosis (7,8). The development of HIV rapid tests has facilitated the massive scale-up of HIV testing and counseling at thousands of testing venues, allowing millions of individuals to receive their HIV diagnosis outside of a primary care facility (9, 10).The purpose of this field validation was to evaluate the performance of four rapid diagnostic tests: Determine HIV-1/2 (Alere Medical Co., Ltd., Japan), SD Bioline HIV-1/2 (Standard Diagnostics, Inc., South Korea), INSTI HIV antibody test (Biolytical Laboratories, Canada), and Uni-Gold HIV-1/2 (Trinity Biotech, Ireland), to accurately diagnose HIV infection.Venous whole-blood specimens were collected into EDTA tubes from consenting patients who tested for HIV infection at eight selected health facilities, representing five regions of Panama (Western Panama, Colón, Gnobe Bugle, Chiriquí, and Guna Yala) during May through August 2014. Eligible patients included men and nonpregnant women Ն18 years of age and pregnant women of any age recruited at these selected sites, which represented ϳ20% of the participants. All samples were tested onsite by the four rapid tests listed above. Kit protocols were strictly followed in carrying out the ...

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Dried tube specimens: A simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings

Cited by 61 publications

References 16 publications

External quality assessment in the voluntary counseling and testing centers in the Brazilian Amazon using dried tube specimens: results of an effectiveness evaluation

External quality assessment in the voluntary counseling and testing centers in the Brazilian Amazon using dried tube specimens: results of an effectiveness evaluation

A Comprehensive Evaluation of the Proficiency Testing Program for the HIV-1 BED Incidence Assay

Field Evaluation of Four Rapid Tests for Diagnosis of HIV Infection in Panama

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