Evaluation of the Rapid BioStar Optical Immunoassay for Detection of Chlamydia trachomatis in Adolescent Women

Abstract

We evaluated the performance of the BioStar Chlamydia OIA (optical immunoassay) in adolescent females (n ‫؍‬ 261) from an inner city population. With a reference standard of two different nucleic acid amplification tests, the sensitivity and specificity of the BioStar Chlamydia OIA were 59.4 and 98.4%, respectively. Due to its relatively low sensitivity, the BioStar Chlamydia OIA should only be used in conjunction with more sensitive laboratory tests unless laboratory tests are unavailable or timely return for treatment is unlikely.Chlamydia trachomatis is the most common sexually transmitted bacterial infection in the world (4). In a majority of people, C. trachomatis infection is asymptomatic or causes only mild clinical symptoms. As a result, few infected people seek medical care and treatment, leading to continued transmission to sexual partners (7). In part, this helps explain the relatively high prevalence of C. trachomatis infection throughout the world, including countries with advanced medical care and public health programs. Antibiotic treatment is highly effective against C. trachomatis infection. Appropriate therapy lowers the risk for development of pelvic inflammatory disease and other sequelae of infection, which include chronic pelvic pain, ectopic pregnancy, and infertility (10). The development of highly sensitive nucleic acid amplification tests (NAATs) has facilitated the screening and detection of C. trachomatis infections (1). However, like C. trachomatis culture, which was the historical "gold standard" method for the detection of C. trachomatis infection, NAATs are only performed in qualified clinical diagnostic laboratories. Patients with a positive NAAT result who are not presumptively treated at the time of their clinic visit are required to return for antibiotic treatment. Among adolescents, who usually have low rates of return, the risk of continued transmission with lack of therapy remains an important concern (11). Even in patients who return for treatment, a long delay between diagnosis and treatment increases the risk for the development of pelvic inflammatory disease, as well as for the transmission of C. trachomatis to sex partners. A potential solution to this problem is the use of rapid diagnostic tests that are performed at the point of care, so that patients are tested and treated during the same visit.The BioStar Chlamydia OIA (optical immunoassay) is a rapid test that was developed for the detection of C. trachomatis in women in physician's office-or clinic-based settings, and it does not require specialized equipment. The performance of the BioStar Chlamydia OIA was previously evaluated for the detection of C. trachomatis in neonatal conjunctivitis (8) and in urogenital infections of women attending sexually transmitted disease (STD) clinics (6,12). In this study, we evaluated, for the first time, the performance of the BioStar Chlamydia OIA in an inner city adolescent female population (5). Two hundred sixty-one female adolescent patients, 13 to 19 years old, who were e...

Point of care diagnostics for sexually transmitted infections: perspectives and advances

“…Several rapid tests for detecting CT were developed between 1998 and 2007. These include the optical immunoassay (OIA) (Inverness [formerly BioStar], Princeton, NJ, USA) [25,26], Clearview Chlamydia (Alere Health Care, Waltham, MA, USA) [27–29], QuickVue (Quidel, San Diego, CA, USA) [30,31]. All are cleared by the US FDA, but lack sensitivity compared with NAAT assays [20].…”

Using a Rapid Communication Approach to Improve a POC Chlamydia Test

“…Currently, three tests have been cleared by the United States FDA: the optical immunoassay (OIA) (Inverness [formerly Biostar], Princeton, NJ), Clearview Chlamydia (Inverness, Princeton, NJ), and QuickVue (Quidel, San Diego, CA). These three POC tests for Chlamydia have reported low sensitivities (25-65%) compared to NAAT, but good specificities (97-100%) and most testing was done using endocervical swabs [6]—[8]. The only study that tested vaginal swabs with Clearview® found a similarly disappointing sensitivity (33%) and high specificity (100%) [8].…”

“…Currently, three POC Chlamydia tests have been cleared by the United States Food and Drug Administration (FDA). Compared to NAAT, these tests have low sensitivities (25-65%), but good specificities (97-100%) when testing was done with endocervical swabs [6]—[8]. However, these sensitivities are too low to be useful in clinical settings where NAAT is available.…”

Medical and Legal Implications of Testing for Sexually Transmitted Infections in Children

“…While these assays have good specificity with endocervical specimens (Ͼ98%), they are insufficiently sensitive compared to the sensitivities of culture and NAATs (5). There are no data on the use of these assays on 498 HAMMERSCHLAG AND GUILLÉN C LIN.…”