Suitability of a new cost-efficient method for the detection of antibodies to HIV and other pathogens in air-dried saliva in population-based studies and for diagnostics

Research area(s):

Project start:
01.01.2002

Project end:
31.12.2005

Co-ordinators:

Institutions:
Norwegian Institute of Public Health,

Funding source(s):
The Research Council of Norway,

Project description:
Antibodies to HIV and other pathogens can be detected in saliva with sensitivities and specificities equivalent to those obtained with blood. However, most oral fluid collection devices are expensive. Recently, a new device (MucoSafe™) was designed for the collection, storage and preparation of saliva samples. Antibodies in air-dried saliva samples are stable after storage without refrigeration for over 12 months. Method: The MucoSafe™ device consists of an absorbent membrane on a cardboard strip specially designed for collecting oral fluids. The device is provided in a plastic bag that is used for transport, storage and/or preparation. Instructions for sample collection and preparation are printed on each bag. The strip is placed in the mouth between the gums and buccal membrane and left in the oral cavity for 3 minutes to absorb oral fluids. The absorbent membrane can be air-dried or the specimen can be prepared and analyzed immediately after collection. Buffer for sample preparation is contained in a separate pouch within each bag. Preliminary investigations: Blood and saliva sample pairs were collected from 34 volunteers with and 201 volunteers without HIV infection in Oslo. All samples were screened for anti-HIV IgG using the Bionor HIV-1&2 assay and GACELISA. The Bionor HIV-1&2 assay is a rapid EIA based on a novel paramagnetic particle technology developed for use with serum, plasma, whole blood or saliva samples. A sensitivity of 100% and specificity of 100% were obtained. An evaluation study of the MucoSafe™ method conducted using samples from 394 patients at the Kilimanjaro Christian Medical Centre in Moshi, Tanzania yielded 97% sensitivity and 99% specificity. Conclusion: Saliva testing for HIV antibodies using specimens collected with the MucoSafe™ device provides a cost-efficient alternative to blood testing. This method is highly suitable for use in large-scale population-based studies, voluntary counseling and testing programs and in clinics with limited laboratory facilities. Current activities: Investigations to optimize air-dried saliva samples for use in diagnostics and epidemiological studies are ongoing.

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