CA1251716A - Diagnostic-test specimen-preparation vial - Google Patents
Diagnostic-test specimen-preparation vialInfo
- Publication number
- CA1251716A CA1251716A CA000482354A CA482354A CA1251716A CA 1251716 A CA1251716 A CA 1251716A CA 000482354 A CA000482354 A CA 000482354A CA 482354 A CA482354 A CA 482354A CA 1251716 A CA1251716 A CA 1251716A
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- CA
- Canada
- Prior art keywords
- specimen
- container
- dispenser
- cap housing
- filtrate
- Prior art date
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- Expired
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Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
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- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Compositions Of Macromolecular Compounds (AREA)
Abstract
DIAGNOSTIC-TEST SPECIMEN-PREPARATION VIAL
ABSTRACT OF THE DISCLOSURE
A specimen-preparation vial for collecting and preparing a specimen of fecal matter or other clinical specimen for a diagnostic test includes a sample-dilution container and a specimen-collection/dispenser top. The sample-dilution container is shaped to contain a liquid in an interior volume. The container has an opening dimensioned to receive the specimen and a sidewall which is yieldable upon manual squeezing. The specimen-collection/dispenser top includes a cap housing which is connectable to the specimen-dilution container for closing the opening of the container.
A specimen-collection tool is connected to the cap housing and projects from the cap housing so that the tool extends into the interior volume of the specimen-dilution container when the cap housing closes the opening of the container.
The specimen-collection/dispenser top also includes a dispenser tip connected to the cap housing. The dispenser tip has a channel passing through it which communicates with the interior volume of the sample-dilution container when the cap housing closes the opening of the container. An end of the channel defines a filtrate-discharge orifice. A
dispenser-tip closure is provided for closing the filtrate-discharge orifice of the channel passing through the dispenser tip. A microfiltration filter is located in the cap housing in a liquid path extending from the interior volume of the sample-dilution container to the filtrate-discharge orifice of the dispenser tip so that liquid flowing from the interior volume of the container to the filtrate-discharge orifice passes through the microfiltration filter.
The microfiltration filter has pores passing through it of dimensions effective to permit virus particles to pass through the pores and to block the passage of particles significantly larger than virus particles.
ABSTRACT OF THE DISCLOSURE
A specimen-preparation vial for collecting and preparing a specimen of fecal matter or other clinical specimen for a diagnostic test includes a sample-dilution container and a specimen-collection/dispenser top. The sample-dilution container is shaped to contain a liquid in an interior volume. The container has an opening dimensioned to receive the specimen and a sidewall which is yieldable upon manual squeezing. The specimen-collection/dispenser top includes a cap housing which is connectable to the specimen-dilution container for closing the opening of the container.
A specimen-collection tool is connected to the cap housing and projects from the cap housing so that the tool extends into the interior volume of the specimen-dilution container when the cap housing closes the opening of the container.
The specimen-collection/dispenser top also includes a dispenser tip connected to the cap housing. The dispenser tip has a channel passing through it which communicates with the interior volume of the sample-dilution container when the cap housing closes the opening of the container. An end of the channel defines a filtrate-discharge orifice. A
dispenser-tip closure is provided for closing the filtrate-discharge orifice of the channel passing through the dispenser tip. A microfiltration filter is located in the cap housing in a liquid path extending from the interior volume of the sample-dilution container to the filtrate-discharge orifice of the dispenser tip so that liquid flowing from the interior volume of the container to the filtrate-discharge orifice passes through the microfiltration filter.
The microfiltration filter has pores passing through it of dimensions effective to permit virus particles to pass through the pores and to block the passage of particles significantly larger than virus particles.
Description
~Z5~7~L6 DIAGNOSTIC-TEST SPECIM~N-PREPARATION VIAL
Technical Field -The present invention relates to a vial for use in preparing specimens for diagnostic tests such as medical tests for detecting certain viruses in fecal matter or other clinical specimens.
Background Art Gastroentestinal diseases are among the most prevalent types of illness in infants and young children.
Only recently have specific virus infections been identified as a major cause of many of these diseases.
One virus, a rotavirus, has been identified as a principal cause of sporadic acute winter gastroenteritis in infants and young children. Children who contract this infection frequently suffer from severe diarrhea and fever, 3~ occasionally accompanied by vomiting. In severe cases, the disease can be fatal. It has been estimated that about half of the infants treated for acute winter gastroenteritis are suffering from a gastroenteritis caused by this virus. The ", ~
~L25~L716 disease is a world-wide problem and is a significant cause of childhood deaths in developing countries.
Diagnosis of gastroenteritis caused by a rotaviral infection is based on the presence of rotavirus particles in the feces. Rotavirus particles are generally shed in large quantities during gastroentestinal rotaviral infections.
Rotavirus par~icles are too small to be observed directly ~ith an optical microscope. However, the characteristically wheel-shaped particles can be observed with an electron microscope. In addition, rotavirus particles can be identified by a number of immunochemical diagnostic procedures, including latex-bound-antibody agglutination, immunofluorescence, and enzyme-linked immunosorbent assay ~5 techniques.
Typically, diagnostic procedures for detecting the presence of rotavirus particles in fecal matter involve a number of preliminary specimen preparations steps which have heretofore been a source of troublesome problems. Ordinarily a specimen of fecal matter must be collected from a soiled diaper or bedpan of an afflicted person using a disposable spatula and transferred to a specimen-container for transport to a clinical laboratory. In the laboratory the specimen is usually mixed with a buffer solu~ion to disperse the fecal matter and any virus particles which may be present in the solution. The mixing step is often carried out in the specimen container used to transport the specimen to the laboratory or in a laboratory beaker. Many te~t procedures further require that any gross debris in the solution of fecal matter be removed. Such gross debris is often removed by centrifugation, in which case the solution must be transferred to a centrifuge tube and spun in a centrifuge.
The supernatant liquid in the centrifuge tube is then used to ~25~L7~6 prepare slides for examination with an electron microscope or used in an immunochemical diagnostic test procedure.
The conventional specimen-preparation procedure described above has a number of significant drawbacks. The procedure generally involves transferring fecal material or solutions containing fecal material from container to container, which is unpleasant for nursing and laboratory personnel and carries a risk of contamination and infection.
Furthermore, the various implements and containers involved must be disposed of or cleaned and sterilized for reuse. The supernatant liquid obtained in the centrifugation step generally includes bacteria or parasitic organisms from the fecal material in addition to whatever virus particles are present. In certain immunochemical diagnostic test procedures for rotaviruses, certain bacteria or other non-viral microorganisms which are occasionally present in fecal matter can interact with the test reagents to give rise to ambiguous or even erroneous test resultsO
International patent application No. PCT/BR82/00013 published under International Publication No. WO 83/01194 on April 14, 1983 by the World Intellectual Property Organization (the '194 publication) discloses a disposable container for collecting a specimen of fecal matter and preparing it for parasitological examination. The container includes a semiflexible specimen-receiver vessel in which a specimen of fecal matter can be diluted with water or other diluent. The container includes a cover which can be screwed on the specimen-receiver vessel. The cover has an opening passing through it from which samples of diluted fecal matter can be expelled for parasitological analysis by squeezing the sides of the specimen-receiver vessel. A plug is provided for sealing the opening in the cover. A seive is fitted ~.2S~7~6 within the cover for straining the solution of fecal matter withdrawn from the container. The orifices of the seive have dimensions which permit the seive to serve in place of gauze or nets of wire or plastic which are used to strain diluted fecal matter in conventional parasitological analysis procedures. Essential in this straining i5 to let, for instance, the parasitic ova to flotate through the sieve. A
specimen-collector stick is attached to the seive for collecting specimens of fecal matter and introducing them into the specimen-receiver vessel.
The container of the '194 publication would have substantial drawbacks were the container to be used to prepare a specimen of fecal matter for testing for the presence of rotavirus. For example, dispersed in the solution of fecal matter expelled from the container of the '194 publication along with whatever virus particles are present can be bacteria and other non-viral microorganisms, as well as gross particles such as certain intestinal parasites and the eggs of such parasites. Bacteria and non-viral microorganisms are small enough to pass through gauze or net strainers used in parasitological examination procedures, and thus would pass through the seive of the container of the '194 publication. As noted above, the presence of such bacteria or non-viral microorganisms can in certain cases interfere with immunochemical diagnostic test procedures for rotavirus.
Disclosure of the Invention We have invented a specimen-preparation vial for collecting and preparing a clinical specimen such as a specimen of fecal matter for a diagnostic test which avoids problems of the prior art noted above.
~25~7~L6 Broadly, the specimen-preparation vial of the invention comprises a specimen-dilution container and a specimen collection/dispenser top for the container.
The specimen-dilution container i5 shaped to contain a liquid in an interior volume and has an opening dimensioned to permit the speci~en to be introduced into the interior volume. A sidewall of the container is yieldable upon manual squeezing.
The specimen-collection/dispenser top also includes a specimen-collection tool connected to the cap housing. The specimen-collection tool projects from the cap housing so that the tool extends into the interior volume of the specimen-dilution container when the opening of the container is closed by the cap housing.
The specimen-collection/dispenser top further includes a dispenser tip and a dispenser-tip closure. The dispenser tip is connected to the cap housing. The dispenser tip has a channel passing through it. An end of the channel defines a filtrate-discharge orifice of the dispenser ~ip.
The channel through the dispenser tip communicates with the interior volume of the specimen-dilution container when the opening of the container is closed by the cap housing~ The dispenser-tip closure is adapted to close the filtrate-discharge orifice of the channel passing through the dispenser tip.
The specimen-collection/dispenser top further includes a microfiltration filter located in the cap housing in a liquid path which extends from the interior volume of the specimen-dilution container to the filtrate-discharge orifice so that liquid which flows from the interior vclume -6- ~5~7~
of the container to the filtrate discharge orifice passes through the microfiltration filter. The microfiltration filter has pores passing through it of dimensions effective to permit virus particles to pass through the pores and to block the passage of particles significantly larger than virus particles, such as bacteria cells. Thus by squeezing the sides of the specimen-dilution container a user can dispense a filtered extract of the specimen in the container, which extract can contain virus particles but which is substantially free of bacteria, other non-viral microorganisms, fatty material, and gross debris.
For use in connection with diagnostic test for rotaviruses, the microfiltration filter of the specimen-preparation vial of the invention preferably has pores of dimensions effective to pass particles having crosswise dimensions of about l-lOum or less and to block particles - having crosswise dimension greater than about l-lOum. The microfiltration filter may be of a woven or nonwoven fabric of cotton, rayon or other fiber or filament. If desired, the microfiltration filter may be made of porous ceramic, charcoal, reticulated foam, sintered beads, or other porous material having pores of the appropriate dimensions. If desired, the microfiltration filter may be impregnated with a reagent material such as antibodies or antigens.
Microfiltration filters made of a fabric are prone to shift or wrinkle. Such fabric microfiltration filters are preferably spatially separated by a fabric nonwoven mesh of monofilament nylon to inhibit shifting and wrinkling of the microfiltration filters.
L25~7~L6 The specimen-collection tool of the sample-preparation vial of the invention is preferably of a generally flat shape having a depression in one end forming a spoon blade. Such a spoon blade can be used to collect specimens of either solid or runny fecal material.
Alternati~ely, the specimen-collection tool could be a flat paddle, a capillary tube, or an absorbent swab.
The dispenser-tip closure of the specimen-collection/dispenser top of the specimen-preparation vial of the invention is preferably a break-away-tab plug seal. The cap-housing, dispenser tip and break-away-tab plug seal are preferably molded as a unitary structure. The ~oint connecting the break-away-tab plug seal ~o the end of the dispenser tip is made sufficiently thin to permit the plug seal to be broken away readily. Breaking the plug seal away from the dispenser tip opens the filtrate-discharge orifice of the dispenser tip. The break-away-tab plug seal is preferably shaped so that, once broken off from the dispenser tip, it can be inserted in the filtrate-discharge orifice.
Alternatively, the dispenser-top-closure of the specimen-collection/dispenser top may be a snap-on or screw-on cap or an on-off valve mechanism.
The dispenser tip preferably has a generally conical shape to facilitate dispensing the fil~rate liquid drop-by-drop. The filtrate-discharge orifice preferably has an inside diameter ~hich is effective to cause the orifice to dispense the filtrate liquid in drops of a volume appropriate for the diagnostic test procedure in which the filtrate is to be used.
-8- 12~7~6 The sample-preparation vial of the present invention is inexpensive to manufacture and can be discarded after a single use. The vial can be marketed prefilled with a test reagent such as a buffer solution sui~able for diluting a specimen in a particular diagnostic test.
The sample preparation vial of the present invention can be used to advantage in a number of diagnostic tests which require extracts of clinical specimens which are substantially free of bacteria, non-viral microorganisms, fatty material, and gross debris. The sample-preparation vial is particularly suited for use in tests for detecting the presence of rotavirus in specimens of fecal matter, including immunochemical diagnostic tests such as latex-bound-antibody agglutination, immunofluorescence, and enzyme-linked immunosorbent assay techniques, as well as electron microscopy analytical procedures. A preferred sample-preparation vial of the present invention was found to eliminate over 90 percent of the bacteria in a solution of fecal matter. Use of the sample-preparation vial of the invention to prepare a filtered extracts of fecal matter for testing was found to improve significantly the sensitivity and specificity of a latex-bound-antibody agglutination test for the presence of rotavirus in the fecal ma~ter.
Brief DescriPtion of the Drawin~s Preferred embodiments of the invention are described below with reference to the following drawings.
FIG. l is a partially cut away front view of a preferred specimen-preparation vial of the present invention with the specimen collection/dispenser top disconnected from the specimen-dilution container.
g ~LZ5~716 FIG. 2 is a partially-exploded cross-sectional view taken along line 2-2 of FIG. l.
FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2.
FIG. 4 is a front view of a spoon member of the cpecimen-preparation vial of FIG. l.
FIG. 5 is a top view of the spoon member of FIG. 4.
Description of the Preferred Embodiments Re~erring now to FIG. l, a specimen preparation vial lO of the present invention comprises a unitary specimen-dilution container 20 and a specimen collection/dispenser top 50.
The specimen-dilution container 20 is a generally cylindrically-shaped vessel molded from polypropylene. The container 20 has a sidewall 30 which is sufficiently thin to yield readily when squeezed by a user, so that, as described below, liquid in the container 20 can be dispensed drop-by-drop by squeezing the sides of the container. The container 20 has an opening 34 which is sufficiently wide in diameter to permit a specimen of fecal matter roughly one ml in volume to be inserted in the container. A neck 40 of the specimen-dilution container 20 is threaded with threads 41 to psrmit the specimen-collection/dispenser top S0 to be screwed on.
As shown best in FIG. 2, the specimen collection/dispenser top 50 comprises a dispenser cap llO, a specimen-collection spoon member 130, and a filter assembly 150.
~25~7~6 The dispenser cap 110 is a unitary structure molded of polystyrene. The dispenser cap 110 includes a generally conical dispenser tip 112 having a filtrate-di~penser passageway 115 extending through it. A break-away-tab plug seal 160 has a plug shaft 162 and a tab grip 164. The plug shaft 162 is breakably connected to a filtrate discharge end of the dispenser tip 112 by a breaka~le joint 165. The plug shaft 162 closes off and seals the filtrate-dispenser passageway 115. The break-away-tab plug seal 1~0 can be detached from the dispenser tip 112 by breaking the plug shaft 162 at the breakable joint 165. Once the plug shaft 162 is broken away, a filtrate-discharge orifice 111 is opened in the dispenser tip 112. Liquid can pass from the filtrate-dispenser passageway 115 through the filtrate-discharge orifice 111 and be dispensed drop-by-drop from the dispenser tip 112. The inside diameter of the filtrate-discharge orifice 111 is selected so that the drops of liquid formed on the dispenser tip 112 have a volume appropriate for the diagnostic procedure in which the drops are to be used.
After the break-tab plug seal 160 has been broken away from the dispenser tip, the plug shaft 162 can be inserted in the filtrate discharge orifice 111 to plug the orifice.
The dispenser cap 110 includes a filter-holder cylinder 118 and a cap-sidewall cylinder 124. The diameter of the cap-sidewall cylinder 124 is larger than the diameter of the filter-holder cylinder 118. The two cylinders 118 and 124 are disposed generally coaxially with respect to one another with the filter-holder cylinder 118 extending from a point within the cap-sidewall cylinder 124 to a point beyond the end of the cap-sidewall cylinder 124. ~n annular container sealing rim 120 connects an end of the cap-sidewall cylinder 124 to a central section of the filter-holder cylinder 118.
2s~716 A generally-conical, annular filter-support rim 113 extends between a base of the dispenser tip 112 and the filter-holder sidewall 118. As may be seen in FIG. 3, eight filter-support ribs 11~ extend generally radially from a central opening 116 of the filter-support rim 113 to an outer perimeter of the rim on the side of the rim facing away from the dispenser tip 112. The filter-support ribs 114 are spaced apart from one another azimuthally at approximately equiangular intervals about the central opening 116 in the ~ilter-support rim 113.
Four filter-assembly-retainer tabs 122 project radially inwardly from an inside surface o~ the filter-holder cylinder 118. The filter-assembly-retainer tabs 122 are spaced apart azimuthally from one another at approximately ninety-degree intervals about the inside surface of the filter-holder cylinder 118 and are spaced apart axially from .the filter support ribs 114 by a filter-assembly retainer distance.
The cap-sidewall cylinder 124 of the dispenser cap 110 is threaded on its inside surface to engage the screw threads 41 on the nec~ 40 of the specimen-dilution container 20. The pitch of the screw threads is sufficiently high to permit the specimen-collection/dispenser top 50 to be screwed on or off the specimen-dilution container 20 in approximately one full rotation. An annular gap between an outer surface of the filter-holder cylinder 118 and an inner surface of the cap-sidewall cylinder 124 defines a container-sealing gap 123. The container-sealing gap 123 is dimensioned to receive and tightly seal a rim around the opening 3~ of the specimen-dilution container 20 when the specimen collection/dispenser top 50 is screwed on the specimen dilution container 20.
-12- ~2s~71~
Turning now to FIGS. 4 and 5, the specimen-collection spoon member 130 comprises a spoon support base 131 and a specimen-collection spoon 140. The spoon support base 131 comprises an annular filter-assembly-retainer rim 132 and first and second cross members 134 and 136 extending across the rim 132. The filter-assembly-retainer rim 132 is dimensioned to fit tightly within the filter-holder cylinder 118 and to engage the filter-assembly-retainer tabs 122.
1~ When the specimen-collection/dispenser top 50 is assembled, the filter assembly 150 is located between the filter-support ribs 114 and the spoon-support base 131. The cross members 134 and 136 of the spoon-~upport base 131 have approximately the same width as the width of the filter-assembly-retainer rim 132 and divide the area inside the rim into four quadrants with an opening 137 in each quadrant. As a result of this arrangement, the spoon-support base 131 supports the filter assembly 15~ ~hile permitting liquid to pass through the openings between the cross members 134 and 136. When the filter-assembly-retainer rim 132 engages the filter-assembly-retainer tabs 122, the spoon-support base 131 holds the filter assembly 150 tightly agains~ filter-support ribs 114, with the retainer rim 132 tending to prevent liquid from flowing around the perimeter of the filter assembly 150 and thereby bypassing the filter.
The specimen-collection spoon 140 of the spoon member 130 is attached ~o the cross member 136 of the spoon-support base 131. The specimen collection spoon 146 comprises a generally flat spoon shaft 144 which has a depression in a first end to define a spoon blade 146. A
second end 142 of the spoon shaft 144 is connected to the cross member 136. The entire spoon member 130 is molded from polypropylene. As shown in FIG. 4, the spoon shaft 144 is , -13- ~5~71~
tapered slightly in a crosswise dimension. In addition, the spoon shaft 144 is flared at its second end 142 in order to strengthen the joint between the shaft and the cross member 136.
The spoon blade 146 can be used to collect a specimen of fecal matter for diagnosis for rotavirus. With the spoon member 130 held in place in the top 50, the spoon shaft 144 projects ax;ally beyond the end of the cap-sidewall cylinder 124. The cap-sidewall cylinder 124 can be used as a handle for manipulating the spoon member 130, thereby facilitating the collection of a specimen of fecal matter for diagnosis. The shape of the spoon blade 146 permits specimens to be collected from either solid or runny fecal material.
Turning again to FIG. 2, the filter assembly 150 includes a nylon mesh filter 152 sandwiched between a first and a second microfitration filter 154 and 156. The filter assembly 150 is located adjacent to the filter-support ribs 114 so that the filter is spaced away from the filter-support rim 113. Spaces between the filter support ribs 114 form channels through which filtrate can flow from the filter into the central opening 116 of the filter-support rim 113.
The microfiltration filters 154 and 156 are made of a porous blotting paper like felt or glas~ fiber material which act as a conventional depth filter retaining microorganisms and particles larger than viruses. In particular, the pores of the microfiltration filters 154 and 156 tend to pass particles having effective crosswise dimensions of less than about l-lOum and to block particles having greater crosswise dimensions. Consequently, rotavirus particles generally pass through the filter unit while non-~LZ5~7il~;
virus microorganisms typically found in fecal matter generally do not. The filter support net 152 is made of a nonwoven monofilament nylon material. The filter support net tends to prevent the microfiltration filters 154 and 156 from drifting together and becoming obstructed. A sitable support net sandwiched between two layers of microfilters has a pore size of about 53um and is commercially available under the trade designation ~CMN53" from Small Parts Inc. of Miami, Florida.
The diagnostic-test specimen-preparation vial 10 can be used to advantage to prepare a filtered extract of fecal matter for a latex-bound-antibody agglutination test for the presence of rotavirus in the fecal matter. The use of the specimen-preparation vial will be described below in terms of carrying out such a test procedure, although it will be appreciated that the specimen-preparation vial can be used to similar advantage in other clinical test pro~edures for virus particles.
Approximately 10 ml of a pH 7.2 buffer solution containing about 0.1 percent sodium azide as a perservative is introduced into the specimen-dilution contained 20. A
suitable buffer solution is commercially available under the trade name "Rotalex ~uffer" from Orion Diagnostica of Espoo, Finland.
The buffer solution may be sealed in the sample-preparation vial 10 for storage for an extended period prior to use by screwing the top 50 on the specimen-dilution container 20 with the break-away-tab plug seal 160 in place.
It is anticipated that the specimen-preparation vial of the invention will ordinarily be sold to users prefilled with an -1 5- ~ 25~7~6 appropriate quantity of buffer solution for a single diagnostic test procedure.
To test for the presence of rotavirus in the stools of a patien~, the specimen collection/dispenser top 50 is removed from the specimen-dilution container 20. The specimen-collection spoon member 130 is used to collect a specimen of fecal matter (e.g. one ml in volume) from the stools of the patient. The spoon member 130 containing the specimen is ~hen reinserted into the specimen-dilution container 20 and the top 50 is ~hreaded onto the container 20 to seal the container. The specimen preparation vial 10 is then shaken vigorously in order to mix the fecal matter and buffer solution thoroughly and thereby disperse the rotavirus, if present, in the buffer solution.
Next, the break-away-tab plug seal 160 is broken off from the dispenser tip 112. The specimen-preparation vial 10 is then inverted and the sides of the specimen-dilution container 20 are gently squeezed. The squeezing of the container 20 forces the solution of fecal matter against the filter assembly 150 and causes a filtrate of filtered fecal extract solution to pass though the filter assembly and flow down the filtrate-dispenser passageway llS to the 25 filtrate-discharge orifice 111 in the dispenser tip 112.
Filtered fecal extract solution is then dispensed drop-by-drop from the filtrate discharge orifice 111 of the dispenser tip 112 by squeezing the sides of the specimen-dilution container 20. The filtered fecal-extract solution is substantially free of bacteria and gross debris, but contains rotavirus particles if the solution of fecal matter in the specimen-dilution container 20 contains rotavirus particles.
-16- ~25~6 The first 10-20 drops of filtered fecal extract solution are discarded. The next two drops are placed respectively on two separate areas of a black, nonabsorbent card. One drop of a rotavirus-sensitive agglutination test reagent is applied to one of the drops of filtered fecal-extract solution on the card and one drop of a nega~ive control reagent is applied to the other drop of filtered fecal-extract solution. The test reagent is a suspension of latex particles to which ~abbit anti-rotavirus antibodies are bound in a medium which contains about 0.1 percent sodium azide as a preservative. ~ suitable test reagent is commercially available under the trade name "Rotalex Test Latex Reagent" from Orion Diagnostica identified above. The negative control reagent is a suspension of albumin bound to latex particles in a medium which contains about 0~1 percent sodium azide as a preservative. A suitable negatlve control reagent is commerically available under the trade name ~Rotalex Non-Reactive Latex Reagent" from Orion Diagnostica.
Each of the two pairs of drops is then stirred gently using a separate clean mixing paddle for each pair to avoid cross mi~ing. The test card is then tilted and rotated for about two minutes to cause the reagents to move in a circular pattern. The presence of agglutination of latex particles in the sample containing the test reagent and the absence of agglutination in the sample containing the negative control indicates that the fecal material contained rotavirus.
Following the test, the break-tab plug seal 160 can be inserted in the filtrate-discharge orifice 111 of the 30 dispenser top 112 to seal the specimen preparation vial 10.
The vial thus sealed can then be discarded with a minimum risk of spillage or infection of personnel administering the test or contamination of the surrounding environment.
-l7- ~25~716 It is not intended to limit the present invention to the specific embodiment described above. For example, the cap housing can be connected to the specimen-dilution container by a snap-on action. It is recognized that this and other changes may be made in the specimen-preparation vial specifically described herein without departing from the scope and teaching of the instant invention, and it is intended to encompass all other embodiments, alternatives and modifications consistent with the invention.
3~
Technical Field -The present invention relates to a vial for use in preparing specimens for diagnostic tests such as medical tests for detecting certain viruses in fecal matter or other clinical specimens.
Background Art Gastroentestinal diseases are among the most prevalent types of illness in infants and young children.
Only recently have specific virus infections been identified as a major cause of many of these diseases.
One virus, a rotavirus, has been identified as a principal cause of sporadic acute winter gastroenteritis in infants and young children. Children who contract this infection frequently suffer from severe diarrhea and fever, 3~ occasionally accompanied by vomiting. In severe cases, the disease can be fatal. It has been estimated that about half of the infants treated for acute winter gastroenteritis are suffering from a gastroenteritis caused by this virus. The ", ~
~L25~L716 disease is a world-wide problem and is a significant cause of childhood deaths in developing countries.
Diagnosis of gastroenteritis caused by a rotaviral infection is based on the presence of rotavirus particles in the feces. Rotavirus particles are generally shed in large quantities during gastroentestinal rotaviral infections.
Rotavirus par~icles are too small to be observed directly ~ith an optical microscope. However, the characteristically wheel-shaped particles can be observed with an electron microscope. In addition, rotavirus particles can be identified by a number of immunochemical diagnostic procedures, including latex-bound-antibody agglutination, immunofluorescence, and enzyme-linked immunosorbent assay ~5 techniques.
Typically, diagnostic procedures for detecting the presence of rotavirus particles in fecal matter involve a number of preliminary specimen preparations steps which have heretofore been a source of troublesome problems. Ordinarily a specimen of fecal matter must be collected from a soiled diaper or bedpan of an afflicted person using a disposable spatula and transferred to a specimen-container for transport to a clinical laboratory. In the laboratory the specimen is usually mixed with a buffer solu~ion to disperse the fecal matter and any virus particles which may be present in the solution. The mixing step is often carried out in the specimen container used to transport the specimen to the laboratory or in a laboratory beaker. Many te~t procedures further require that any gross debris in the solution of fecal matter be removed. Such gross debris is often removed by centrifugation, in which case the solution must be transferred to a centrifuge tube and spun in a centrifuge.
The supernatant liquid in the centrifuge tube is then used to ~25~L7~6 prepare slides for examination with an electron microscope or used in an immunochemical diagnostic test procedure.
The conventional specimen-preparation procedure described above has a number of significant drawbacks. The procedure generally involves transferring fecal material or solutions containing fecal material from container to container, which is unpleasant for nursing and laboratory personnel and carries a risk of contamination and infection.
Furthermore, the various implements and containers involved must be disposed of or cleaned and sterilized for reuse. The supernatant liquid obtained in the centrifugation step generally includes bacteria or parasitic organisms from the fecal material in addition to whatever virus particles are present. In certain immunochemical diagnostic test procedures for rotaviruses, certain bacteria or other non-viral microorganisms which are occasionally present in fecal matter can interact with the test reagents to give rise to ambiguous or even erroneous test resultsO
International patent application No. PCT/BR82/00013 published under International Publication No. WO 83/01194 on April 14, 1983 by the World Intellectual Property Organization (the '194 publication) discloses a disposable container for collecting a specimen of fecal matter and preparing it for parasitological examination. The container includes a semiflexible specimen-receiver vessel in which a specimen of fecal matter can be diluted with water or other diluent. The container includes a cover which can be screwed on the specimen-receiver vessel. The cover has an opening passing through it from which samples of diluted fecal matter can be expelled for parasitological analysis by squeezing the sides of the specimen-receiver vessel. A plug is provided for sealing the opening in the cover. A seive is fitted ~.2S~7~6 within the cover for straining the solution of fecal matter withdrawn from the container. The orifices of the seive have dimensions which permit the seive to serve in place of gauze or nets of wire or plastic which are used to strain diluted fecal matter in conventional parasitological analysis procedures. Essential in this straining i5 to let, for instance, the parasitic ova to flotate through the sieve. A
specimen-collector stick is attached to the seive for collecting specimens of fecal matter and introducing them into the specimen-receiver vessel.
The container of the '194 publication would have substantial drawbacks were the container to be used to prepare a specimen of fecal matter for testing for the presence of rotavirus. For example, dispersed in the solution of fecal matter expelled from the container of the '194 publication along with whatever virus particles are present can be bacteria and other non-viral microorganisms, as well as gross particles such as certain intestinal parasites and the eggs of such parasites. Bacteria and non-viral microorganisms are small enough to pass through gauze or net strainers used in parasitological examination procedures, and thus would pass through the seive of the container of the '194 publication. As noted above, the presence of such bacteria or non-viral microorganisms can in certain cases interfere with immunochemical diagnostic test procedures for rotavirus.
Disclosure of the Invention We have invented a specimen-preparation vial for collecting and preparing a clinical specimen such as a specimen of fecal matter for a diagnostic test which avoids problems of the prior art noted above.
~25~7~L6 Broadly, the specimen-preparation vial of the invention comprises a specimen-dilution container and a specimen collection/dispenser top for the container.
The specimen-dilution container i5 shaped to contain a liquid in an interior volume and has an opening dimensioned to permit the speci~en to be introduced into the interior volume. A sidewall of the container is yieldable upon manual squeezing.
The specimen-collection/dispenser top also includes a specimen-collection tool connected to the cap housing. The specimen-collection tool projects from the cap housing so that the tool extends into the interior volume of the specimen-dilution container when the opening of the container is closed by the cap housing.
The specimen-collection/dispenser top further includes a dispenser tip and a dispenser-tip closure. The dispenser tip is connected to the cap housing. The dispenser tip has a channel passing through it. An end of the channel defines a filtrate-discharge orifice of the dispenser ~ip.
The channel through the dispenser tip communicates with the interior volume of the specimen-dilution container when the opening of the container is closed by the cap housing~ The dispenser-tip closure is adapted to close the filtrate-discharge orifice of the channel passing through the dispenser tip.
The specimen-collection/dispenser top further includes a microfiltration filter located in the cap housing in a liquid path which extends from the interior volume of the specimen-dilution container to the filtrate-discharge orifice so that liquid which flows from the interior vclume -6- ~5~7~
of the container to the filtrate discharge orifice passes through the microfiltration filter. The microfiltration filter has pores passing through it of dimensions effective to permit virus particles to pass through the pores and to block the passage of particles significantly larger than virus particles, such as bacteria cells. Thus by squeezing the sides of the specimen-dilution container a user can dispense a filtered extract of the specimen in the container, which extract can contain virus particles but which is substantially free of bacteria, other non-viral microorganisms, fatty material, and gross debris.
For use in connection with diagnostic test for rotaviruses, the microfiltration filter of the specimen-preparation vial of the invention preferably has pores of dimensions effective to pass particles having crosswise dimensions of about l-lOum or less and to block particles - having crosswise dimension greater than about l-lOum. The microfiltration filter may be of a woven or nonwoven fabric of cotton, rayon or other fiber or filament. If desired, the microfiltration filter may be made of porous ceramic, charcoal, reticulated foam, sintered beads, or other porous material having pores of the appropriate dimensions. If desired, the microfiltration filter may be impregnated with a reagent material such as antibodies or antigens.
Microfiltration filters made of a fabric are prone to shift or wrinkle. Such fabric microfiltration filters are preferably spatially separated by a fabric nonwoven mesh of monofilament nylon to inhibit shifting and wrinkling of the microfiltration filters.
L25~7~L6 The specimen-collection tool of the sample-preparation vial of the invention is preferably of a generally flat shape having a depression in one end forming a spoon blade. Such a spoon blade can be used to collect specimens of either solid or runny fecal material.
Alternati~ely, the specimen-collection tool could be a flat paddle, a capillary tube, or an absorbent swab.
The dispenser-tip closure of the specimen-collection/dispenser top of the specimen-preparation vial of the invention is preferably a break-away-tab plug seal. The cap-housing, dispenser tip and break-away-tab plug seal are preferably molded as a unitary structure. The ~oint connecting the break-away-tab plug seal ~o the end of the dispenser tip is made sufficiently thin to permit the plug seal to be broken away readily. Breaking the plug seal away from the dispenser tip opens the filtrate-discharge orifice of the dispenser tip. The break-away-tab plug seal is preferably shaped so that, once broken off from the dispenser tip, it can be inserted in the filtrate-discharge orifice.
Alternatively, the dispenser-top-closure of the specimen-collection/dispenser top may be a snap-on or screw-on cap or an on-off valve mechanism.
The dispenser tip preferably has a generally conical shape to facilitate dispensing the fil~rate liquid drop-by-drop. The filtrate-discharge orifice preferably has an inside diameter ~hich is effective to cause the orifice to dispense the filtrate liquid in drops of a volume appropriate for the diagnostic test procedure in which the filtrate is to be used.
-8- 12~7~6 The sample-preparation vial of the present invention is inexpensive to manufacture and can be discarded after a single use. The vial can be marketed prefilled with a test reagent such as a buffer solution sui~able for diluting a specimen in a particular diagnostic test.
The sample preparation vial of the present invention can be used to advantage in a number of diagnostic tests which require extracts of clinical specimens which are substantially free of bacteria, non-viral microorganisms, fatty material, and gross debris. The sample-preparation vial is particularly suited for use in tests for detecting the presence of rotavirus in specimens of fecal matter, including immunochemical diagnostic tests such as latex-bound-antibody agglutination, immunofluorescence, and enzyme-linked immunosorbent assay techniques, as well as electron microscopy analytical procedures. A preferred sample-preparation vial of the present invention was found to eliminate over 90 percent of the bacteria in a solution of fecal matter. Use of the sample-preparation vial of the invention to prepare a filtered extracts of fecal matter for testing was found to improve significantly the sensitivity and specificity of a latex-bound-antibody agglutination test for the presence of rotavirus in the fecal ma~ter.
Brief DescriPtion of the Drawin~s Preferred embodiments of the invention are described below with reference to the following drawings.
FIG. l is a partially cut away front view of a preferred specimen-preparation vial of the present invention with the specimen collection/dispenser top disconnected from the specimen-dilution container.
g ~LZ5~716 FIG. 2 is a partially-exploded cross-sectional view taken along line 2-2 of FIG. l.
FIG. 3 is a cross-sectional view taken along line 3-3 of FIG. 2.
FIG. 4 is a front view of a spoon member of the cpecimen-preparation vial of FIG. l.
FIG. 5 is a top view of the spoon member of FIG. 4.
Description of the Preferred Embodiments Re~erring now to FIG. l, a specimen preparation vial lO of the present invention comprises a unitary specimen-dilution container 20 and a specimen collection/dispenser top 50.
The specimen-dilution container 20 is a generally cylindrically-shaped vessel molded from polypropylene. The container 20 has a sidewall 30 which is sufficiently thin to yield readily when squeezed by a user, so that, as described below, liquid in the container 20 can be dispensed drop-by-drop by squeezing the sides of the container. The container 20 has an opening 34 which is sufficiently wide in diameter to permit a specimen of fecal matter roughly one ml in volume to be inserted in the container. A neck 40 of the specimen-dilution container 20 is threaded with threads 41 to psrmit the specimen-collection/dispenser top S0 to be screwed on.
As shown best in FIG. 2, the specimen collection/dispenser top 50 comprises a dispenser cap llO, a specimen-collection spoon member 130, and a filter assembly 150.
~25~7~6 The dispenser cap 110 is a unitary structure molded of polystyrene. The dispenser cap 110 includes a generally conical dispenser tip 112 having a filtrate-di~penser passageway 115 extending through it. A break-away-tab plug seal 160 has a plug shaft 162 and a tab grip 164. The plug shaft 162 is breakably connected to a filtrate discharge end of the dispenser tip 112 by a breaka~le joint 165. The plug shaft 162 closes off and seals the filtrate-dispenser passageway 115. The break-away-tab plug seal 1~0 can be detached from the dispenser tip 112 by breaking the plug shaft 162 at the breakable joint 165. Once the plug shaft 162 is broken away, a filtrate-discharge orifice 111 is opened in the dispenser tip 112. Liquid can pass from the filtrate-dispenser passageway 115 through the filtrate-discharge orifice 111 and be dispensed drop-by-drop from the dispenser tip 112. The inside diameter of the filtrate-discharge orifice 111 is selected so that the drops of liquid formed on the dispenser tip 112 have a volume appropriate for the diagnostic procedure in which the drops are to be used.
After the break-tab plug seal 160 has been broken away from the dispenser tip, the plug shaft 162 can be inserted in the filtrate discharge orifice 111 to plug the orifice.
The dispenser cap 110 includes a filter-holder cylinder 118 and a cap-sidewall cylinder 124. The diameter of the cap-sidewall cylinder 124 is larger than the diameter of the filter-holder cylinder 118. The two cylinders 118 and 124 are disposed generally coaxially with respect to one another with the filter-holder cylinder 118 extending from a point within the cap-sidewall cylinder 124 to a point beyond the end of the cap-sidewall cylinder 124. ~n annular container sealing rim 120 connects an end of the cap-sidewall cylinder 124 to a central section of the filter-holder cylinder 118.
2s~716 A generally-conical, annular filter-support rim 113 extends between a base of the dispenser tip 112 and the filter-holder sidewall 118. As may be seen in FIG. 3, eight filter-support ribs 11~ extend generally radially from a central opening 116 of the filter-support rim 113 to an outer perimeter of the rim on the side of the rim facing away from the dispenser tip 112. The filter-support ribs 114 are spaced apart from one another azimuthally at approximately equiangular intervals about the central opening 116 in the ~ilter-support rim 113.
Four filter-assembly-retainer tabs 122 project radially inwardly from an inside surface o~ the filter-holder cylinder 118. The filter-assembly-retainer tabs 122 are spaced apart azimuthally from one another at approximately ninety-degree intervals about the inside surface of the filter-holder cylinder 118 and are spaced apart axially from .the filter support ribs 114 by a filter-assembly retainer distance.
The cap-sidewall cylinder 124 of the dispenser cap 110 is threaded on its inside surface to engage the screw threads 41 on the nec~ 40 of the specimen-dilution container 20. The pitch of the screw threads is sufficiently high to permit the specimen-collection/dispenser top 50 to be screwed on or off the specimen-dilution container 20 in approximately one full rotation. An annular gap between an outer surface of the filter-holder cylinder 118 and an inner surface of the cap-sidewall cylinder 124 defines a container-sealing gap 123. The container-sealing gap 123 is dimensioned to receive and tightly seal a rim around the opening 3~ of the specimen-dilution container 20 when the specimen collection/dispenser top 50 is screwed on the specimen dilution container 20.
-12- ~2s~71~
Turning now to FIGS. 4 and 5, the specimen-collection spoon member 130 comprises a spoon support base 131 and a specimen-collection spoon 140. The spoon support base 131 comprises an annular filter-assembly-retainer rim 132 and first and second cross members 134 and 136 extending across the rim 132. The filter-assembly-retainer rim 132 is dimensioned to fit tightly within the filter-holder cylinder 118 and to engage the filter-assembly-retainer tabs 122.
1~ When the specimen-collection/dispenser top 50 is assembled, the filter assembly 150 is located between the filter-support ribs 114 and the spoon-support base 131. The cross members 134 and 136 of the spoon-~upport base 131 have approximately the same width as the width of the filter-assembly-retainer rim 132 and divide the area inside the rim into four quadrants with an opening 137 in each quadrant. As a result of this arrangement, the spoon-support base 131 supports the filter assembly 15~ ~hile permitting liquid to pass through the openings between the cross members 134 and 136. When the filter-assembly-retainer rim 132 engages the filter-assembly-retainer tabs 122, the spoon-support base 131 holds the filter assembly 150 tightly agains~ filter-support ribs 114, with the retainer rim 132 tending to prevent liquid from flowing around the perimeter of the filter assembly 150 and thereby bypassing the filter.
The specimen-collection spoon 140 of the spoon member 130 is attached ~o the cross member 136 of the spoon-support base 131. The specimen collection spoon 146 comprises a generally flat spoon shaft 144 which has a depression in a first end to define a spoon blade 146. A
second end 142 of the spoon shaft 144 is connected to the cross member 136. The entire spoon member 130 is molded from polypropylene. As shown in FIG. 4, the spoon shaft 144 is , -13- ~5~71~
tapered slightly in a crosswise dimension. In addition, the spoon shaft 144 is flared at its second end 142 in order to strengthen the joint between the shaft and the cross member 136.
The spoon blade 146 can be used to collect a specimen of fecal matter for diagnosis for rotavirus. With the spoon member 130 held in place in the top 50, the spoon shaft 144 projects ax;ally beyond the end of the cap-sidewall cylinder 124. The cap-sidewall cylinder 124 can be used as a handle for manipulating the spoon member 130, thereby facilitating the collection of a specimen of fecal matter for diagnosis. The shape of the spoon blade 146 permits specimens to be collected from either solid or runny fecal material.
Turning again to FIG. 2, the filter assembly 150 includes a nylon mesh filter 152 sandwiched between a first and a second microfitration filter 154 and 156. The filter assembly 150 is located adjacent to the filter-support ribs 114 so that the filter is spaced away from the filter-support rim 113. Spaces between the filter support ribs 114 form channels through which filtrate can flow from the filter into the central opening 116 of the filter-support rim 113.
The microfiltration filters 154 and 156 are made of a porous blotting paper like felt or glas~ fiber material which act as a conventional depth filter retaining microorganisms and particles larger than viruses. In particular, the pores of the microfiltration filters 154 and 156 tend to pass particles having effective crosswise dimensions of less than about l-lOum and to block particles having greater crosswise dimensions. Consequently, rotavirus particles generally pass through the filter unit while non-~LZ5~7il~;
virus microorganisms typically found in fecal matter generally do not. The filter support net 152 is made of a nonwoven monofilament nylon material. The filter support net tends to prevent the microfiltration filters 154 and 156 from drifting together and becoming obstructed. A sitable support net sandwiched between two layers of microfilters has a pore size of about 53um and is commercially available under the trade designation ~CMN53" from Small Parts Inc. of Miami, Florida.
The diagnostic-test specimen-preparation vial 10 can be used to advantage to prepare a filtered extract of fecal matter for a latex-bound-antibody agglutination test for the presence of rotavirus in the fecal matter. The use of the specimen-preparation vial will be described below in terms of carrying out such a test procedure, although it will be appreciated that the specimen-preparation vial can be used to similar advantage in other clinical test pro~edures for virus particles.
Approximately 10 ml of a pH 7.2 buffer solution containing about 0.1 percent sodium azide as a perservative is introduced into the specimen-dilution contained 20. A
suitable buffer solution is commercially available under the trade name "Rotalex ~uffer" from Orion Diagnostica of Espoo, Finland.
The buffer solution may be sealed in the sample-preparation vial 10 for storage for an extended period prior to use by screwing the top 50 on the specimen-dilution container 20 with the break-away-tab plug seal 160 in place.
It is anticipated that the specimen-preparation vial of the invention will ordinarily be sold to users prefilled with an -1 5- ~ 25~7~6 appropriate quantity of buffer solution for a single diagnostic test procedure.
To test for the presence of rotavirus in the stools of a patien~, the specimen collection/dispenser top 50 is removed from the specimen-dilution container 20. The specimen-collection spoon member 130 is used to collect a specimen of fecal matter (e.g. one ml in volume) from the stools of the patient. The spoon member 130 containing the specimen is ~hen reinserted into the specimen-dilution container 20 and the top 50 is ~hreaded onto the container 20 to seal the container. The specimen preparation vial 10 is then shaken vigorously in order to mix the fecal matter and buffer solution thoroughly and thereby disperse the rotavirus, if present, in the buffer solution.
Next, the break-away-tab plug seal 160 is broken off from the dispenser tip 112. The specimen-preparation vial 10 is then inverted and the sides of the specimen-dilution container 20 are gently squeezed. The squeezing of the container 20 forces the solution of fecal matter against the filter assembly 150 and causes a filtrate of filtered fecal extract solution to pass though the filter assembly and flow down the filtrate-dispenser passageway llS to the 25 filtrate-discharge orifice 111 in the dispenser tip 112.
Filtered fecal extract solution is then dispensed drop-by-drop from the filtrate discharge orifice 111 of the dispenser tip 112 by squeezing the sides of the specimen-dilution container 20. The filtered fecal-extract solution is substantially free of bacteria and gross debris, but contains rotavirus particles if the solution of fecal matter in the specimen-dilution container 20 contains rotavirus particles.
-16- ~25~6 The first 10-20 drops of filtered fecal extract solution are discarded. The next two drops are placed respectively on two separate areas of a black, nonabsorbent card. One drop of a rotavirus-sensitive agglutination test reagent is applied to one of the drops of filtered fecal-extract solution on the card and one drop of a nega~ive control reagent is applied to the other drop of filtered fecal-extract solution. The test reagent is a suspension of latex particles to which ~abbit anti-rotavirus antibodies are bound in a medium which contains about 0.1 percent sodium azide as a preservative. ~ suitable test reagent is commercially available under the trade name "Rotalex Test Latex Reagent" from Orion Diagnostica identified above. The negative control reagent is a suspension of albumin bound to latex particles in a medium which contains about 0~1 percent sodium azide as a preservative. A suitable negatlve control reagent is commerically available under the trade name ~Rotalex Non-Reactive Latex Reagent" from Orion Diagnostica.
Each of the two pairs of drops is then stirred gently using a separate clean mixing paddle for each pair to avoid cross mi~ing. The test card is then tilted and rotated for about two minutes to cause the reagents to move in a circular pattern. The presence of agglutination of latex particles in the sample containing the test reagent and the absence of agglutination in the sample containing the negative control indicates that the fecal material contained rotavirus.
Following the test, the break-tab plug seal 160 can be inserted in the filtrate-discharge orifice 111 of the 30 dispenser top 112 to seal the specimen preparation vial 10.
The vial thus sealed can then be discarded with a minimum risk of spillage or infection of personnel administering the test or contamination of the surrounding environment.
-l7- ~25~716 It is not intended to limit the present invention to the specific embodiment described above. For example, the cap housing can be connected to the specimen-dilution container by a snap-on action. It is recognized that this and other changes may be made in the specimen-preparation vial specifically described herein without departing from the scope and teaching of the instant invention, and it is intended to encompass all other embodiments, alternatives and modifications consistent with the invention.
3~
Claims (10)
1. A specimen-preparation vial for collecting and preparing a specimen for a diagnostic test, comprising:
(a) a simple-dilution container shaped to contain a liquid in an interior volume, the container having an opening dimensioned to receive the specimen, a sidewall of the container being yieldable upon manual squeezing; and (b) a specimen-collection/dispenser top including:
(b.1) a cap housing connectable to the specimen-dilution container for closing the opening of the container;
(b.2) a specimen-collection tool connected to the cap housing, the specimen-collection tool projecting from the cap housing so that the specimen-collection tool extends into the interior volume of the specimen-dilution container when the cap housing closes the opening of the container;
(b.3) a dispenser tip connected to the cap housing, the dispenser tip having a channel passing through it which communicates with the interior volume of the sample-dilution container when the cap housing closes the opening of the container, an end of the channel defining a filtrate-discharge orifice;
(b.4) dispenser-tip closure means for closing the filtrate-discharge orifice of the channel passing through the dispenser tip; and (b.5) a microfiltration filter located in the cap housing in a liquid path extending from the interior volume of the sample-dilution container to the filtrate discharge orifice of the channel passing through the dispenser tip so that liquid flowing from the interior volume of the container to the filtrate-discharge orifice passes through the microfiltration filter, the microfiltration filter having pores passing through it of dimensions effective to permit virus particles to pass through the pores and to block the passage of particles significantly larger than virus particles.
(a) a simple-dilution container shaped to contain a liquid in an interior volume, the container having an opening dimensioned to receive the specimen, a sidewall of the container being yieldable upon manual squeezing; and (b) a specimen-collection/dispenser top including:
(b.1) a cap housing connectable to the specimen-dilution container for closing the opening of the container;
(b.2) a specimen-collection tool connected to the cap housing, the specimen-collection tool projecting from the cap housing so that the specimen-collection tool extends into the interior volume of the specimen-dilution container when the cap housing closes the opening of the container;
(b.3) a dispenser tip connected to the cap housing, the dispenser tip having a channel passing through it which communicates with the interior volume of the sample-dilution container when the cap housing closes the opening of the container, an end of the channel defining a filtrate-discharge orifice;
(b.4) dispenser-tip closure means for closing the filtrate-discharge orifice of the channel passing through the dispenser tip; and (b.5) a microfiltration filter located in the cap housing in a liquid path extending from the interior volume of the sample-dilution container to the filtrate discharge orifice of the channel passing through the dispenser tip so that liquid flowing from the interior volume of the container to the filtrate-discharge orifice passes through the microfiltration filter, the microfiltration filter having pores passing through it of dimensions effective to permit virus particles to pass through the pores and to block the passage of particles significantly larger than virus particles.
2. The specimen preparation vial of claim 1 in which the microfiltration filter comprises a porous fabric formed of organic, inorganic or natural fibers.
3. The specimen-preparation vial of claim 2 in which the pores of the microfiltration filter are dimensioned so that particles having effective crosswise dimensions of about 10um or less tend to pass through the pores and particles having effective crosswise dimensions of greater than about 10um tend to be blocked.
4. The specimen-preparation vial of claim 2 in which the microfiltration filters are sandwiched on opposite surfaces of a porous filter-support pad.
5. The specimen-preparation vial of claim 4 in which the filter-support pad comprises a fabric mesh of nylon.
6. The specimen-preparation vial of claim 1 in which the dispenser-tip closure means is a break-away tab plug seal connected to an end of the dispenser tip by a breakable joint to close off and seal the channel passing through the dispenser tip, the break-away-tab plug seal having a plug shaft adapted to be inserted in the filtrate-discharge orifice at the end of the channel passing through the dispenser tip to plug the orifice after the break-away-tab plug seal has been broken away from the dispenser tip.
7. The specimen-preparation vial of claim 6 in which the dispenser tip is generally conical in shape.
8. The specimen-preparation vial of claim 7 in which the specimen-collection tool is detachably connected to the cap housing.
9. The specimen-preparation vial of claim 8 in which the specimen collection tool has a tool-support base which cooperates with the cap housing to retain the microfiltration filter in the cap housing.
10. The specimen-preparation vial of claim 9 in which the specimen-collection tool is shaped to form a spoon.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US65138084A | 1984-09-17 | 1984-09-17 | |
| US651,380 | 1984-09-17 | ||
| US70396785A | 1985-02-21 | 1985-02-21 | |
| US703,967 | 1991-05-22 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1251716A true CA1251716A (en) | 1989-03-28 |
Family
ID=27096056
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000482354A Expired CA1251716A (en) | 1984-09-17 | 1985-05-24 | Diagnostic-test specimen-preparation vial |
Country Status (9)
| Country | Link |
|---|---|
| KR (1) | KR890000078B1 (en) |
| AU (1) | AU571697B2 (en) |
| BR (1) | BR8502683A (en) |
| CA (1) | CA1251716A (en) |
| DK (1) | DK226385A (en) |
| ES (1) | ES8608845A1 (en) |
| IN (1) | IN165193B (en) |
| NO (1) | NO852064L (en) |
| PT (1) | PT80549A (en) |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4293405A (en) * | 1971-06-07 | 1981-10-06 | Greenwald Robert J | Fecal examination device (B) |
| US3811326A (en) * | 1972-02-10 | 1974-05-21 | V Sokol | Disposable dilution system |
| US4559837A (en) * | 1981-10-01 | 1985-12-24 | Cerqueira Francisco L | Faeces collection and concentration receiver |
-
1985
- 1985-05-21 DK DK226385A patent/DK226385A/en not_active Application Discontinuation
- 1985-05-23 AU AU42801/85A patent/AU571697B2/en not_active Ceased
- 1985-05-23 NO NO852064A patent/NO852064L/en unknown
- 1985-05-24 CA CA000482354A patent/CA1251716A/en not_active Expired
- 1985-05-27 IN IN388/MAS/85A patent/IN165193B/en unknown
- 1985-05-29 PT PT80549A patent/PT80549A/en not_active IP Right Cessation
- 1985-06-03 ES ES543827A patent/ES8608845A1/en not_active Expired
- 1985-06-04 BR BR8502683A patent/BR8502683A/en unknown
- 1985-06-12 KR KR1019850004146A patent/KR890000078B1/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| ES543827A0 (en) | 1986-07-16 |
| BR8502683A (en) | 1986-05-27 |
| KR890000078B1 (en) | 1989-03-07 |
| PT80549A (en) | 1985-06-01 |
| IN165193B (en) | 1989-08-26 |
| DK226385D0 (en) | 1985-05-21 |
| KR860002260A (en) | 1986-04-24 |
| AU4280185A (en) | 1986-04-10 |
| AU571697B2 (en) | 1988-04-21 |
| DK226385A (en) | 1986-03-18 |
| NO852064L (en) | 1986-03-18 |
| ES8608845A1 (en) | 1986-07-16 |
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| MKEX | Expiry | ||
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