An evaluation of oral-fluid collection devices for the determination of rubella antibody status in a rural Ethiopian community

Abstract

We compared 3 different oral-fluid collection devices to assess their suitability for use in community studies of rubella antibody. Of 58 individuals enrolled from 13 households from a southern Ethiopian village, 38 provided a blood sample and oral fluids by the 3 devices: 2 proprietary, Omni-SAL and OraSure, and a third a polystyrene sponge swab (Sponge). The Sponge swab, used like a toothbrush, was most acceptable to survey staff and to participants of all ages, although it proved ill-adapted for fluid extraction. The other devices more often caused participant discomfort or anxiety, particularly in the young. Statistical comparison of rubella-specific immunoglobulin (Ig) G in oral fluid, measured by antibody-capture radioimmunoassay, and in serum, by indirect enzyme-linked immunosorbent assay, showed no clear differences between the devices in oral-fluid performance. Specificity range was 75-100% and sensitivity 73-85%, relative to serum. Specific-antibody levels declined with increasing age, with concomitant decreases in sensitivity, as previously documented. The relationship between specific IgG and total IgG in oral fluid differed by device. Specific IgG levels were highly correlated between paired samples using the Sponge device. We consider the Sponge device to be the most suitable for community survey work, although the extraction method requires improvement. Further work is needed to improve the sensitivity of antibody status determination in adults.

HIV bio-behavioural survey among men who have sex with men in Barcelona, Bratislava, Bucharest, Ljubljana, Prague and Verona, 2008-2009

“…Oral fluid testing simplifies the diagnostic process in specific populations in which drawing blood is difficult and dangerous. As previously demonstrated in other studies, the number of oral fluid collections in all sites confirmed the general acceptability of the study by MSM in outreach settings [16,24]. In our study, an info-pack containing a condom, a lubricant and information about STD prevention and screening centres available in the area was given to respondents in order to facilitate the enrolment and to promote safer sex and testing practice, during the data collection.…”

“…The method used was consistent with the approach adopted in previous studies [15][16][17][18][19][20][21]. In the TLS, spaces (or locations) are venues attended by the target population; times refer to specific days and time periods when the target population congregates in each space.…”

“…The advantage of oral fluid collection for testing of infection is evident as it is a minimally invasive method for serological monitoring which is easy and safe. It has proven to be acceptable for various target audiences and it does not require trained staff [16,17]. Therefore, the use of oral fluid as a means for biological testing is of crucial importance in order to gather valid and reliable information about the spread of HIV among hard to reach populations such as MSM.…”

Improving sensitivity of oral fluid testing in IgG prevalence studies: application of mixture models to a rubella antibody survey

“…The importance of including the 'weak positive ' component is demonstrated by the greatly improved fit over a model with just positive and negative components. The increase with age in the proportion of positives in the 'weak positive ' component, particularly noticeable after age 15 years, reflects the decay of rubella specific antibody levels in persons infected many years previously as observed in other studies [4][5][6][7]. The approach of using strong and weak positive components to introduce flexibility into the infected distribution worked well in this study because the distribution of results for the uninfected population did not change with age (Fig.…”

Identifying Infections with Respiratory Syncytial Virus by Using Specific Immunoglobulin G (IgG) and IgA Enzyme-Linked Immunosorbent Assays with Oral-Fluid Samples

“…Oral fluid was collected using a well-evaluated (10, 19) sponge device (Oracol; Malvern Medical Development, Worcester, United Kingdom) that was rubbed firmly along the gums for 1 min. Extraction and storage methods are detailed elsewhere (11,21). Ethical approval for this study was provided by the Kenya National Ethical Review Committee and the Coventry Research Ethics Committee, Coventry, United Kingdom.…”