Abstract. An evaluation of three new rapid diagnostic test kits for human immunodeficiency virus types 1 and 2 (HIV-1/2), hepatitis B surface antigen (HBsAg), and syphilis involved a two-phase comparison of rapid diagnostic assays using prospectively collected from hospitals and clinics in Ho Chi Minh City, Vietnam. After specificity and sensitivity testing, three new rapid diagnostic test kits were tested in parallel with six commonly used diagnostic test kits. The Determine HIV-1/2 test had fewer indeterminate or equivocal results than the Capillus HIV-1/HIV-2 or HIV Blot 2.2 tests. However, the Determine HIV-1/2 test yielded one false-positive result when compared with the Serodia HIV, HIV Blot 2.2, and microparticle enzyme immunoassay (IMx) HIV tests. The Serodia HBsAg test yielded more false-negative results when compared with the Determine HBsAg diagnostic test kit. The results of the syphilis diagnostic tests evaluated in this clinical trial consistently agreed with those of the rapid plasma reagin test for syphilis. The Determine Syphilis Treponema pallidum (TP) test had three false-positive results compared with the Serodia TP and the Serodia TP•particle agglutination (PA) tests, which had two false-positive results that were confirmed as negative by an ELISA. Application of these serologic tests within this comparative evaluation framework, using the World Health Organization alternative testing strategies, proved to be an effective way to determine serostatus related to HIV, hepatitis B, and syphilis.In many developing areas worldwide, field and clinic laboratory capabilities may be insufficient for the detection of infectious agents for definitive clinical diagnostic purposes. The absence of simple, rapid diagnostic testing methods for sexually transmitted diseases (STDs) and hepatitis has significantly hampered public health efforts to retard the spread of these diseases. The inability to provide tests for quick recognition of human immunodeficiency virus (HIV), hepatitis B, and syphilis has allowed infected individuals to unknowingly spread the disease through sexual contacts, blood donations, and intravenous needle sharing. In cities throughout Asia, current laboratory evaluation of blood specimens may preclude case follow-up and counseling due to a long time lag between initial sample collection and conventional test completion. High-risk populations typically seek treatment during clinic visits in association with acute episodes and are not likely to return a second time for test results.Diagnostic technology is adapting itself for application in developing countries. Advancements in the laboratory diagnosis of HIV/acquired immunodeficiency syndrome (AIDS), hepatitis B, and syphilis have considered the following conditions, including: 1) speed of results; 2) test validity and accuracy; 3) minimal specimen requirement; 4) variable type of specimen, including whole blood; 5) ease of test kit use, with few requirements for specialized laboratory equipment; and 6) stable reagents, requiring no refri...

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A study of acute hepatitis was conducted in Hanoi, Viet Nam, from January 1993 to February 1995; 188 sera from clinical hepatitis cases were screened by enzyme-linked immunosorbent assay for immunoglobulin (Ig) M anti-hepatitis A virus (HAV), IgM anti-hepatitis B core antigen (HBc), IgG anti-hepatitis C virus (HCV), IgG anti-hepatitis E virus (HEV) and IgM anti-HEV. Additionally, 187 sera from control subjects, matched by age, sex and month of admission, with no recent history of hepatitis, were tested for comparative purposes. There was serological evidence of recent HAV (29%) and hepatitis B virus (24%) infection in 53% of cases (2 mixed infections), compared with 2% of controls. HCV infections were detected in 10% of cases (with no IgM anti-HAV or IgM anti-HBc) and in 1% of control sera. There was no significant difference in the proportion of IgG anti-HEV positive sera between cases (in the absence of IgM anti-HAV or IgM anti-HBc) (21%) and controls (14%); 3% of all case sera were IgM anti-HEV positive. Younger cases (< 20 years) were more likely to have recent HAV infections (41%) than those aged > or = 20 years (21%) (P < 0.01). In contrast, a higher percentage of adult cases had IgM anti-HBc, IgG anti-HCV and IgG anti-HEV (in the absence of recent HAV or HBV infection) than did children. No seasonal trend in hepatitis admissions was detected, nor an association between water-borne infections (HAV and HEV) and the warmer months. Hepatitis patients lived throughout Hanoi and surrounding areas, with no identifiable geographical clustering, regardless of serological marker.