The present invention relates to a method and device for the collection and optional evaluation of oral fluids.

BACKGROUND

There is an incentive to replace, where possible, invasive blood testing with non-invasive saliva testing due to several reasons including convenience and cost. Non-invasive test are a prerequisite for conducting body fluid analysis test away from professional health provides. Also, a significant part of the population experience pronounced needle aversion, specifically infants, children and to an extent also elderly. The risk of infection is also mitigated by the replacement of invasive blood testing with saliva testing. A skilled person (nurse) must typically be present when performing an invasive blood test adding complexity and cost compared to non-invasive saliva testing.

For the reasons mentioned above there is an impetus for an increased number of regulatory approved saliva testing protocols in the future.

The present invention provides a convenient device for the collection and optional evaluation of oral fluids. The device is designed to be fully integrated with standardized evacuated fluid sample vials.

GB 2484805 discloses an assembly for the collection and testing of oral fluids, e.g. saliva.

US 2012/0095369 A1 relates to a device for sampling body fluids.

US 2016/0133817 A1 discloses a saliva collection system comprising a pacifier portion, a stiffener, a collector and a pad compression tube. This concept is based on collecting saliva with an absorbent pad. Absorbed saliva is separated from the pad by compression. There is no teaching suggesting that saliva be collected by using an evacuated sample vial.

U.S. Pat. No. 5,910,122 discloses a method for saliva collection where saliva is collected by placing a sponge in the oral cavity. Saliva is absorbed into the sponge and separated from sponge by a pipette. The method and device in U.S. Pat. No. 5,910,122 is not adaptable for the accommodation of evacuated sealed sample vials.

WO 9720502 relates to a pacifier for the collection of saliva comprising an absorbent. The saliva needs in a further stage be separated from the absorbent.

SUMMARY

In general, the present invention relates to a method and device suitable for the collection and optional testing of oral fluids, e.g. saliva, using a sealed evacuated sample container (5). The vacuum or sub-atmospheric pressure present in the sealed evacuated sample container, once the seal is broken, is used for transferring oral fluids accumulated in an intra oral member (11), e.g. the flexible part of a pacifier, into the sample container (5). Hence, the sealed evacuated sample container provides at least two properties, transportation of oral fluids and storage.

