Direct specimen collection device and cassette

Abstract

The present disclosure relates to a specimen collection device comprising ventilation means for drying a collected specimen. The device further comprises a cassette into which the specimen collected is secured to maintain evidentiary chain of cus tody requirements while providing unobstructed access to a collected specimen for automated analysis. Methods of using the device are also provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Patent Application No. 62 / 294,780 filed Feb. 12, 2016 and U.S. Provisional Patent Application No. 62 / 452,737 filed Jan. 31, 2017 the entire disclosures of which are incorporated herein by reference.FIELD OF THE INVENTION[0002]The present disclosure relates to a specimen collection device comprising ventilation means for efficiently drying a collected specimen and a cassette into which the specimen collected is secured to maintain evidentiary chain of custody requirements while providing unobstructed access to a collected specimen for automated analysis. Methods of using the device are also provided.BACKGROUND OF THE INVENTION[0003]Increasingly in law enforcement it is necessary to collect biological samples as evidence of a crime or for use as identifying information of a particular human as is the case of DNA collection from suspects. In the collection of biological specimens, it is...

AI Technical Summary

Benefits of technology

[0014]In yet another aspect, a method of supporting a biological sample collection absorbent is provided. The method provides for collecting a biological specimen, efficiently drying the collected specimen, using the original absorbent in an automated analytical system, and allowing for storage of the biological sample collection absorbent. The method comprises providing a specimen collection assembly comprising a sample collection carrier and a collection absorbent connected to the specimen collection carrier through a raised cap. The method further comprises providing a handle cover comprising an attachment means for removably connecting the handle to the specimen collection assembly, wherein the handle cover permits manipulation of the specimen collection assembly during specimen collection when the handle cover is attached to the specimen collection assembly, and wherein the handle cover comprises ventilation holes. The method also comprises providing a sliding cover removably and slidably connected to the handle cover, the sliding cover having an elongated body and a head connected to the body on one end of the body and a protrusion that engages the raised cap when the sliding cover is moved forwardly on the handle cover thereby raising the head of the sliding cover above the collection absorbent and creating a ventilation gap between the head of the sliding cover and the collection absorbent, and wherein the head further comprises ventilation holes. In the method, the sample collection assembly and the sliding cover are connected to the handle cover to produce a sample collector. The sliding cover is slid backwardly to expose the sample collection absorbent to collect a specimen. A biological sample is collected by contacting the biological sample with the collection absorbent. After collecting the biological sample, the sliding cover is moved forwardly to cover the sample collection absorbent, thereby creating a ventilation gap between the handle cover and the collection absorbent. The sample is then allowed to dry. The sliding cover is then removed from the handle cover, the sample carrier is connected to a cassette, and the handle cover is removed from the sample collection carrier. The collection cassette is then stored.

Problems solved by technology

In the collection of biological specimens, it is necessary to associate information about the subject with the specimen at the time of collection, as there is no manner for identifying a biological specimen by simple inspection.

A particular issue in the collection of the biological sample is that the sample collection is often taken from a living, uncooperative person.

Once the specimen is on the absorbent, the handle is no longer needed, and presents a complicating factor in specimen storage and analysis due to the extra bulk and size of a handle.

This lack of visual characteristics foils any attempt to properly identify such a biological fluid or cellular sample once it has become separated from its identifying information.

Another problem or issue presented in the analysis of biological specimens is the need to extract or transfer the collected sample from the original collection absorbent and onto an alternate medium to permit analysis or testing of the specimen using the analysis equipment that is available in the selected laboratory.

This separation of specimen from identifying information can lead to mistakes in associating the specimen with the correct subject or suspect or can lead to the “chain of custody” being open to question in court and a failure of proof of a crime.

Sample misidentification is a major source of error both in laboratory analysis and in substantiating criminal evidence.

Importantly, another issue relating to the collection of biological specimens is that biological specimens degrade, hindering or affecting downstream analysis.

This is especially true if the collected biological specimen remains wet for extended periods of time, and / or is not treated with stabilizing formulations.

However, such stabilizing methods known in the art are associated with problems.

In particular, the collected specimen may not transfer to the stabilizing matrix in a consistent or reproducible manner.

Further, if the swab used to collect the sample is separate and distinct from the stabilizing matrix receiving the sample, then forensic chain of custody issues arise.

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