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

Abstract

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 ...

Diagnosis of Human Immunodeficiency Virus Infection

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Towards more accurate HIV testing in sub‐Saharan Africa: a multi‐site evaluation of HIV RDTs and risk factors for false positives

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HIV Screening among Patients with Newly Diagnosed Solid and Hematologic Malignancies in a Tertiary Hospital in the Philippines

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