FIELD OF THE INVENTION

This invention pertains generally to methods and devices for detecting and/or identifying microorganisms in a biological sample and, more particularly to a liquid soluble collection device for microorganism screening.

BACKGROUND OF THE INVENTION

Human and animal populations have been and continue to be significantly impacted by infectious diseases including bacterial, viral, or other origin infectious disease. Infectious respiratory diseases of viral origin including those caused by SARS-Co-V-2 and influenza have impacted human health on a large scale. In particular, both SARS-Co-V-2 and influenza have caused global pandemics. Socially isolating or quarantining infected individuals or suspected of being infected with infectious respiratory pathogens is an effective tool of controlling spread of disease. The identification of infected individuals especially those with no or mild symptoms is critical.

The collection of biological specimens including biological fluid is required for diagnostic testing for the causative agents of infectious diseases. Sample collection from the mouth, nose, throat, and other locations may be accomplished by brushing or wiping a body surface with a swab. For example, some diseases may be detected by analysis of swabs, or fluid obtained from swabs, such as throat swabs, nasal swabs, cheek swabs, or other swabs, such as, COVID-19, influenza and other respiratory disorders; tuberculosis; bacterial infections such as diphtheria, whooping cough, and those caused be caused by staphylococcus, streptococcus, pneumococcus, and other bacteria; viral infections, such as, e.g., adenovirus infections; some genetic diseases caused by or related to a subject's genetic characteristics; and other diseases and disorders.

Analysis of the sample typically requires that the collected fluid or tissue be transferred from the swab to a vessel, slide, or analysis device. However, such transfer is often incomplete, and loss or degradation of the sample may occur before analysis. Accordingly, improved swabbing methods and swab collection devices are required.

This background information is provided for the purpose of making known information believed by the applicant to be of possible relevance to the present invention. No admission is necessarily intended, nor should be construed, that any of the preceding information constitutes prior art against the present invention.

SUMMARY OF THE INVENTION

An object of the present invention is to provide a liquid soluble collection device for microorganism screening. In accordance with an aspect of the present invention, there is provided a biological specimen collection swab comprising a rod, terminating in a tip; and a soluble layer coating said tip.

In accordance with another aspect of the invention, there is provided a biological specimen collection system comprising the swab of the invention and a container for receiving a swab, optionally the container comprises a solubilizing liquid, wherein the solubilizing liquid solubilizes or dissolves the soluble layer.

In accordance with another aspect of the invention, there is provided a collection swab comprising: a substrate comprising paper or an aramid polymer, the substrate comprising a surface having a collection area to be placed against a surface from which a sample is collected; and a soluble coating disposed on the surface of the substrate in the collection area.

In accordance with another aspect of the invention, there is provided a collection card comprising a substrate comprising paper or an aramid polymer, the substrate comprising a surface having a plurality of collection areas marked thereon; and a soluble coating disposed on the surface of the substrate in each collection area.

In accordance with another aspect of the invention, there is provided a method of collecting a biological sample for analysis comprising, contacting a biological surface with the tip of the swab of the invention, and solubilizing or dissolving the soluble layer with a solubilizing liquid, wherein the solubilizing liquid solubilizes or dissolves the soluble layer and; wherein the biological surface is optionally a nasal or oral surface.

In accordance with another aspect of the invention, there is provided a method of collecting a sample for analysis comprising, contacting a surface with the collection swab of the invention, and solubilizing or dissolving the soluble layer with a solubilizing liquid, wherein the solubilizing liquid solubilizes or dissolves the soluble layer. In accordance with some embodiments, the surface is a non-biological surface and optionally a frequent contact surface such a door knob. BRIEF DESCRIPTION OF THE DRAWINGS

These and other features of the invention will become more apparent in the following detailed description in which reference is made to the appended drawings.

FIG. 1 illustrates a biological specimen collection swab in accordance with an aspect of the invention.

FIG. 2 illustrates a biological specimen collection system in accordance with an aspect of the invention.

FIG. 3 illustrates a collection swab in accordance with an aspect of the invention.

FIG. 4 illustrates a collection card for multiple samples.

DETAILED DESCRIPTION OF THE INVENTION

Effective containment of the spread of infectious diseases including those caused by SARS- Co-V-2 and influenza especially influenza strains with pandemic potential is facilitated by the rapid identification of infected individuals. The COVID-19 pandemic has highlighted the need for rapid screening of a large number of individuals. Specimen collection is the first step in the screening process.

In some embodiments, the specimens or samples are collected from humans. In other embodiments, the specimens or samples are collected from animals.

The present invention provides an improved swab and collection system for specimen or sample collection. Specimen or samples collected include those obtained by nasal or throat swabs, saliva, blood or serum. In some embodiments, the specimens or samples are collected from humans. In other embodiments, the specimens or samples are collected from animals.

In still other embodiments, samples include surface wipes including surface wipes of high touch areas such as door handles.

The swabs of the invention can be used in screening for microorganisms including bacteria, virus and fungi.

Alternative the swabs of the invention can be used in routine sample collection including blood and saliva collection. To facilitate processing of samples, the swabs of the invention comprise material that dissolves or is solubilized when immersed in a solubilizing liquid or solution thereby substantially transferring the majority or all of the collected material to the solution. In some embodiments, the material dissolves at a lower temperature, for example, about 5°C to about 40°C, in some embodiments, material dissolves at room temperature. In some embodiments, the solubilizing liquid or solution is water or an aqueous solution. In some embodiments, the aqueous solutions pH is adjusted to promote solubilizing of the material.

The dissolvable or soluble material may be any material that dissolves and does not impact the downstream diagnostic testing. In some embodiments, the material can be in the form of a coating, a fabric (either woven or non-woven) or a film (including 1 to 250 gsm basis weight). Alternatively, the material can be spun, optionally into filaments, into a padding or cotton ball like material. The dissolvable or soluble material includes aqueous-soluble polymer, Alkali-soluble polymer including but not limited to Ethylene-vinyl acetate (EVA), Polyvinyl Alcohol (PVA), Polyamide (PA), Polyester (PET) or protein base fiber.

In preferred embodiments, the material is ethylene-vinyl acetate (EVA). Accordingly, in preferred embodiments, the biological specimen collection swab comprises a rod, terminating in a tip; and a soluble layer comprising ethylene-vinyl acetate (EVA) coating the tip.

In some embodiments, the materials are hydrophilic in nature to facilitate water permeation through the material.

Optionally, the swab may be coated with a material that absorbs and attracts microorganisms. For example, the swabs may have an electrostatic surface coating to attract more microorganisms to improve harvesting and detection accuracy.

After sample collection, the swab may be stored for a period of time prior to processing. In some embodiments, the swab may be stored in the solubilizing liquid. The solubilizing liquid will depend on the material used. In some embodiments, the solubilizing liquid is an aqueous solution, the pH of which may be adjusted based on the characteristics of the material. In some embodiments, the material is soluble at an alkaline pH.

Specimen or samples collected by the improved swab or collection system are processable by means known in the art including PCR based methods, antibody, antigen or proteinbased methods.

In some embodiments, the swab is part of a kit that includes detection reagents. In some embodiments, the solubilizing solution is specifically configured for the screening or testing protocol used. Accordingly, in some embodiments, the solution includes one or more of buffer agents, alcohol, surfactants, chaotropes, detergents, defoaming agents and reducing agents.

In some embodiments, the solubilizing solution includes one or more primers, probes, labels, enzymes and other reagents known in the art.

Referring to FIG. 1 , in some embodiments, the invention provides a biological specimen collection swab (10). The swab includes a rod (12) and head or tip. The rod may be manufactured from rolled paper, plastic, wood or material that would be known in the art. In The head includes a substrate (14) that is coated with the dissolvable or soluble material (16). In alternative embodiments, the entire head is manufactured from the dissolvable or soluble material. Optionally, the head is coated with an electrostatic material.

Referring to FIG. 2, in some embodiments, the invention provides biological specimen collection system (20) comprising a collection swab (10), storage container (15) with lid or cap (30). In some embodiments, the cap (30) includes a hole, optionally with a seal, for the rod of the swab. In alterative embodiments, the cap completely closes the container. The storage container (15) is optionally filed with the solubilizing solution (25) or alternative storage solution.

Referring to FIG. 3, in some embodiments, the invention provides collection swab (40) comprising a substrate (45) and dissolvable or soluble material coating (50). The substrate is generally flexible and may be manufactured from a variety of woven and non-woven materials. In some embodiments, the substrate is paper product.

Referring to FIG. 4, in some embodiments, the invention provides a collection card (60) for multiple samples comprising a generally stiff or non-flexible substrate (70) printed with marked and optionally perforated sample spots (65). Each sample is coated with the dissolvable or soluble material. During processing, individual sample spots are placed in the solubilizing material. This embodiment is specifically designed for screening large number of animals, for example, in a farm setting where blood samples from animals are blotted on the sample spot for later processing.

Although the invention has been described with reference to certain specific embodiments, various modifications thereof will be apparent to those skilled in the art without departing from the spirit and scope of the invention. All such modifications as would be apparent to one skilled in the art are intended to be included within the scope of the following claims.