CA1039633A - Diagnostic device for liquid samples - Google Patents

Diagnostic device for liquid samples

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Publication number
CA1039633A
CA1039633A CA234,338A CA234338A CA1039633A CA 1039633 A CA1039633 A CA 1039633A CA 234338 A CA234338 A CA 234338A CA 1039633 A CA1039633 A CA 1039633A
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CA
Canada
Prior art keywords
receptacle
medium
sample
culture medium
closure
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA234,338A
Other languages
French (fr)
Inventor
Gary Libman
William J. Binard
Harish A. Patel
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kendall Co
Original Assignee
Kendall Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kendall Co filed Critical Kendall Co
Application granted granted Critical
Publication of CA1039633A publication Critical patent/CA1039633A/en
Expired legal-status Critical Current

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  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

DIAGNOSTIC DEVICE FOR LIQUID SAMPLES

ABSTRACT OF THE DISCLOSURE
The present invention is concerned with a diagnostic device for collection of body fluids which is especially conveni-ent for taking mid-stream urine specimens. Generally the device comprises a bipartible receptacle having a removable portion which contains a bacteriological medium. The removable portion may be incubated and analyzed subsequent to substantially immedi-ate inoculation of the medium with any pathogens present in the fluid.

Description

BACKGROUND OF THE INVENTION
, .
~ This invention relates to the detection of the pres-;~;; ence of, and type of, bacteria in body fluids (human and animal), which is an ever-constant problem for the medical profession both for diagnostic and treatment reasons. Unreliability of laboratory tests is not uncommon. Often a time lag is present between collection of the body fluid to be tested and the inocu-lation of a culture medium therewith. Some microorganisms multi-ply so rapidly that such a time lag makes the distinction between a significant infection and an overgrowth of contami-nants impossible. Other microorganisms are so sensitive to their environment that they may not survive a time lag and a delay of inoculation of culture media will not present a true ' picture forthe diagnostician. Any apparatus and/or procedure ,~ that will eliminate or shorten the time lag will greatly help laboratory analysts.
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One of the major problems confronting hospitals today is the accurate detection of urinary tract infections. The presence of bacteria in urine is termed bacteriuria. Clean voided urine from normal individuals generally contains micro-;' organisms that are indigenous residents of the urethra. Urine in the bladder is ordinarily sterile. The presence of any bac-teria in the bladder or upper urinary tract is considered abnor-mal. Significant bacteriuria is a term for describing the num-bers of bacteria in voided urine that exceed the numbers usually due to contamination from the anterior urethra. Inasmuch as ~ voided urine is an ideal growth medium for microorganisms, it is ; imperative that an accurate assessment of bacteriuria be made immediately after a specimen is voided. Pxior art techniques for bacterial culturing have disadvantages over our invention in that each has one or more of the following drawbacks: diffi-culty of interpretation or quantitation, difficulty of perform-ance, excessive expense and time consumption, significant delay between collection of the sample and inoculation of the medium.
An advantage of our invention is that with an embodi-ment of our device a patient may void directly into the collec-tion device, yet the culture medium may be substantially immedi-- ately inoculated with that specimen, by the patient, if desired.
Our invention also allows subculturing of bacterial colonies for further biochemical studies. This is difficult with many of the prior art culturing devices.
Our invention avoids the difficulties of interpreta-tion and collection in the test tubes containing agar which have been used.
With regard to the detection of gonorrhea from a urine sample, it has been necessary in the past to centrifuge the sam-ple to precipitate the heavier bacterial material from the liquid, including the Neisseria gonorrhoeae bacteria, if present, for .. .
inoculating a culture medium. An advantage of our invention is that we are able to culture a urine sample for detection of N.

. gonorrhoeae without having to centrifuge the urine sample.

BRIEF SUMMARY OF THE INVENTION
: . .
The principal feature of the present invention is the provision of an apparatus for collecting body fluids, particu-larly the mid-stream collecting of urine, in a simplified manner which provides for the substantially immediate inoculation of a bacteriological medium by the fluid.
A further feature of our invention is the provision of a method for inoculating a bacterial medium with a body fluid .. .. ~

:`
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~039633 substantially immediately after the fluid leaves the body.
~` The device of the present invention includes a con-tainer having a portion or section thereof retaining a culture medium. The container includes a chamber adapted to receive a liquid sample without contact of the medium with the sample. It is important that the fluid not be collected directly on the medium to prevent damage to the medium, such as the breaking up thereof. Preferably the container is adapted to receive a , direct urine discharge. More particularly, our preferred device is bipartible and includes a fluid receptacle and a first close . ~
~; fitting lid therefor and removable therefrom having disposed on the underside thereof a bacteriological medium. After inocula-- tion of the medium with the fluid, a cover can be placed on the ; removed lid to form an "incubation package". If desired, a sec-ond close fitting lid can be placed over the fluid at this point ; and the fluid therein further analyzed. Alternatively, it is .....
feasible that the receptacle and lid therefor can remain intact, with provision made for discard of fluid in excess of that which - is required to inoculate the medium and this, then, forms the "incubation package."
:.
In the method of our invention a liquid sample is ~ directed into a container having a section containing a culture medium. This is done without contacting the medium with the incoming sample so as to avoid damage to the medium and the con-tainer is thereafter inverted to inoculate the medium retained in the container with the sample received in the container.

A feature of the invention is that it is especially suitable in obtaining a urine specimen from the mid-stream of micturition, after the urethra has been flushed by a flow from the bladder.

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Another feature of the invention is that the device allows substantially immediate and direct inoculation of a bac-teriological medium with fluid suspected of containing pathogens.
Yet another feature of the invention is that the diag-nostic device accomplished collection of fluid, inoculation of culture medium, and furnishes an apparatus for incubation.
Still another feature is that the device employs bac--` teriological media surfaces that allow easy interpretation of diagnostic results and easy subculturing for biochemical evalua-` 10 tion, and the positioning, if desired, of selective and non- -selective agars adjacent to one another for ease in presumptive .. ,; , - identification. ~-A further feature of the invention is that the media .;.:i , can be incubated in a horizontal positlon, which is more relia-ble than vertical incubation found in many commercial products.
'' Also a feature of the invention is that its use shows :: .: - .. , an excellent correlation with standard techniques in enumeration ~ and in presumptive identification of organisms.
;' Yet a further feature of the invention is the ability to culture a urine sample for detection of Neisseria gonorrhoeae bacteria without having to centrifuge the sample. Another fea-ture is the ability to culture a urine sample for the detection `
of yeast infections. -Further features will become readily apparent from the appended claims and from the following description of the embodi- ~
: ments of the invention taken in conjunction with the drawings. -'' ,:

DESCRIPTION OF THE DRAWINGS

In the drawings:
- ::-: -Figure 1 is an isometric view of the collection and :''' '~' ~' : . , . ., : : ........................... .
.. . . -. ~ : .

. -inoculation apparatus of the present invention;
Figure 2 is an exploded view of the embodiment of Figure 1, showing the inoculation lid or cap of the apparatus : removed from the upper portion of the body of the collection app-aratus, the cover for the inoculation lid removed and the second lid removed from the lower portion of the body of the collection . apparatus;
~ Figure 3 is an inner bottom view of the inoculation : lid or cap of Figures 1 and 2, showing the bacteriological media therein;
Figure 4 is an inner bottom view of the inoculation lid or cap of Figures 1 and 2 without the media and showing the means for securing the media in the lid;
- Figure 5 shows a cover in place on the inoculation lid : of the view of Figure 3, forming the "incubation package" of the :':
: invention; and ~; Figure 6 is a cross-section of the view of Figure 5, taken along the line 6-6 thereof.

DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring now to Figures 1 and 2, a collection and inoculation device generally 10 comprises receptacle 11 and a first, inoculation, lid, generally 12, having a top portion 14.
The rim 13 of lid 12 may be internally threaded, as shown in Figure 2 at 15, to mesh with threads 16 annularly disposed around the upper end 17 of receptacle 11. Cover, generally 25, may be conveniently removably affixed to device 10 as by fitting over lid 12. A second, closure, lid, generally 27, may be con-veniently removably affixed to receptacle 11 as by frictionally fitting about the bottom 18 thereof. Preferably lid 27 is . . .

` ~0;19633 internally threaded as shown in Figure 2 at 28 to mesh, when and if desired, with threads 16. The device is fabricated of conven-tional materials, i.e. metal, glass, plastic, etc. It is, of course, necessary that the material used for the manufacture of the device not react chemically with the body fluid being col-lected. Preferably the device is transparent. We prefer to use a rigid plastic for the receptacle, with the lid or lids of plas-tic or metal. The cover for the device is preferably made of a ; transparent plastic with a low moisture permeability rate. -10As illustrated in Figure 3, inoculation lid 12 has affixed to the inner top surface 19 thereof a bacteriological medium 20. This is conveniently done as by placing the media onto prongs 22, shown in Figure 4. If more than a single cul- ;
ture medium is employed, we have found it is preferable to phys-ically separate the media within the inner top surface, in order to avoid adulteration, such as by leaving spacer 24 between them.
While Figure 3 shows media 20 in two semicircular configurations, - any convenient configuration of media is feasible so long as an annular area 23 is left around the circumference of the lid suf- -ficiently wide to receive the upper end 17 of receptacle 11 and , allow the lid to be securely fastened to receptacle 11.
Preferably we use two or more different media, selec- ~
tive and nonselective, adjacent to one another, thereby achiev- -ing the important feature of presumptive identification of patho- -gens in a single culturing. The preferred agars we use are CLED ~-agar and MacConkey Agar or EMB Agar. CLED agar (Cystine Lactose Electrolyte Deficient Agar) is ideal in enumerating and presump-tively identifying urinary flora. It supports growth of urinary pathogens and contaminants. Additionally, the lack of electro-lytes prevents a common culturing problem - swarming of Proteus.
' .

;

~ 9633 Organisms can be presumptively identified by color of colonies and media and/or morphology ofcolonies. MacConkey Agar and EMB
Agar are well-known differential media for detection and isola-tion of enteric microorganisms. MacConkey and EMB agars have been used in hospitals for many years. The common gram negative organisms (responsible for more than 90% of urinary tract infec-tions) can be identified readily with MacConkey Agar and EMB
i Agar.

Figures 5 and 6 show the incubation package wherein ~,.
rim 13 and the inner lid 19 containing bacteriological medium is ` enclosed by cover 25 fitting snugly thereover. Cover 25 includes ` a flange portion 26 for ease in seating and unseating cover 25 in an aseptic manner, thus not complicating the diagnostic results.
In operation, assuming collection of urine is desired, - device 10 is given to a person from whom it is desired to obtain a urine specimen. Receptacle 11 is preferably of a size to allow urine to be voided directly therein. A doctor or techni-cian advises the person regarding when the specimen is to be col-lected, i.e. first emission urine, mid-stream, etc. The person from whom the specimen is to be received removes the lid 12 from the bipartible device. After lid 12 has been removed, the urine is collected in receptacle 11 and lid 12 is replaced on the receptacle. Device 10 is then inverted sufficiently to let the liquid contact the media for a brief period of time to allow for - an aliquot amount to be absorbed onto the surface. After inocu-lation the device is returned to its upright position, the lid 12 is again removed and cover 25 therefor is grasped by its flange edge 26 to unseat it from its waiting position and placed over the underside 19 of lid 12. Thus cover 25 and lid, gener-~ ~039633 ally 12, provide a package ready to be incubated in the pre- ;-ferred horizontal position. Any excess fluid can be discarded from receptacle 11 or, if desired, may be sealed with second, closure, lid 27, and used for further analysis.
If it is desired to culture the urine for the micro-organism Neisseria gonorrhoeae we have found that it is feasible to circumvent centrifuging by using a receptacle of sufficient volume to allow settling out of the microorganism onto the media when the device is tilted or inverted for on the order of at ;}:
least about two minutes, with inoculation taking usually not more than ten minutes. When it is desired to culture for this microorganism, the agar employed is a standard gonococcal medium, i.e. Transgrow or Thayer-Martin.
It is seen that with the use of our invention no time ;~
lag occurs between sampling and inoculating of bacterial culture media and an incubation package is provided that is exceptional . ::
` with regard to providing identification of pathogens and ease of -subculturing for biochemical evaluation. A system is provided which correlates to a high degree with standard technique in , enumeration and presumptive identification of organisms. The ~ ease and simplicity of the technique, together with its reliabil-; ity, make our invention of particular value to the busy labora-. .
tory. ;
The foregoing disclosure is offered for public dissemi-nation in return for the grant of a patent. Although it is detailed to ensure adequacy and aid understanding, this is not intended to prejudice that purpose of a patent which is to cover each new inventive concept therein no matter how others may later -disguise it by variations in form or additions or further improve-ments.

, ., - , . . .

Claims (14)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A diagnostic device for a liquid discharge compris-ing, a container having a generally planar section retaining a culture medium, with said medium being disposed only in a planar configuration in said section, and a chamber separable from said generally planar section and having a sufficient depth and volume to receive a substantial quantity of said liquid discharge with-out contact of said medium with said discharge, said medium fac-ing the collected discharge in said chamber, and said container being tilted to a position with said medium in a generally hori-zontal configuration to simultaneously inoculate all of said medium throughout a selected period of time.
2. A diagnostic device for a liquid sample compris-ing, a receptacle having a chamber, a top, and an opening at said top communicating with said chamber, a culture medium, and a lid having a generally planar section, means for retaining said medium in a generally planar configuration on an undersurface of said lid section, and means for removably securing the lid to the top of said receptacle to close the receptacle opening with said medium facing said chamber, with said chamber having a suf-ficient depth and volume to receive a substantial quantity of the sample and to retain the sample in the chamber without contact of the medium by the sample while the lid is secured on the recep-tacle and is disposed in an upright position, said sample being received in said chamber with the lid removed from the receptacle and without contacting the medium with the sample, said lid being secured to said receptacle to close the chamber, and said device being inverted to simultaneously inoculate all of said medium in a generally horizontal configuration of the medium throughout a selected period of time.
3. The device of claim 2 wherein said chamber has sufficient volume and depth to receive a urine discharge without overflow of the discharge therefrom.
4. A diagnostic device for use with a sample of body fluid, said diagnostic device comprising a bipartible receptacle and a culture medium, said receptacle having a first portion and a second portion, said first portion having said culture medium disposed in a generally planar configuration therewithin, said first portion being removable from said second portion to an open position and reclosable to a closed position, said second portion having a sufficient volume to directly receive a substan-tial quantity of said sample, said receptacle being inverted when said first portion is in the closed position, said sample being received in said second portion when said first portion is in an open position, said first portion being placed in the closed posi-tion and said receptacle being inverted to thereby contact said culture medium with said sample and to simultaneously inoculate the planar culture medium throughout a selected period of time with the planar medium disposed in a generally horizontal configu-ration.
5. The device of claim 4 including cover means for said first portion comprising a substantially close-fitting lid having a graspable flange portion therearound for aseptically cov-ring said first portion after inoculation of said culture medium with said sample whereby to form an incubation package.
6. The device of claim 4 including means for covering said first portion after inoculation of said culture medium with said sample whereby to form an incubation package and means for covering said second portion after inoculation of said culture medium with said sample whereby to contain said fluid for further analysis.
7. A method of diagnosing a liquid sample with a culture medium using a container which retains the culture medium in a generally planar and horizontal configuration, comprising the steps of:
directing the liquid sample into a container without contacting the medium with the incoming sample; and tilting the container while simultaneously inocu-lating the medium retained in the container with the sample received in the container throughout a selected period of time.
8. A method of diagnosing a liquid sample with a culture medium, comprising the steps of:
directing the liquid sample into a receptacle for retaining the sample;
closing the receptacle with a closure containing said medium and with the medium facing the sample retained in the receptacle;
inverting the receptacle; and simultaneously inoculating all of the medium through-out a selected period of time while maintaining the medium in a generally planar and horizontal configuration.
9. In the method of culturing a sample of urine from a patient on a bacteriological medium, using a receptacle having a retaining portion and closure including an inside and an out-side, the improvement comprising the steps of:
affixing the medium to the inside of the closure for said receptacle in a generally planar configuration facing the inside of the retaining portion of said receptacle;
collecting a discharge of urine from the patient in the retaining portion of said receptacle with said closure removed therefrom;
closing said receptacle with said closure; and inverting said receptacle and closure while simul-taneously covering said medium with the collected discharge for a selected period of time to assure inoculation of the entire medium.
10. In the method of claim 9, the further steps of:
re-inverting said receptacle and said closure;
removing said closure from said receptacle;
aseptically placing a cover over said culture medium;
and incubating said culture medium.
11. In the method of claim 9, the further steps of:
re-inverting said receptacle and said closure;
removing said closure from said receptacle;
aseptically placing a cover over said culture medium;
incubating said culture medium; and thereafter covering said receptacle with a second closure.
12. In the method of diagnosing a liquid sample for the presence of Neisseria gonorrhoeae with a gonococcal culture medium using a receptacle having a closure and retaining portion including an inside and an outside, said retaining portion being capable of holding a substantial volume of said liquid, the improvement comprising the steps of:
affixing said medium to the inside of the closure for said receptacle;
inserting a substantial volume of the liquid sample into said retaining portion of said receptacle with said closure removed therefrom;
closing said retaining portion of said receptacle with said closure; and inverting said receptacle for at least about two minutes to allow said volume to contact said medium sufficiently to cause settling out of N. gonorrhoeae microorganisms on said culture medium.
13. The method of claim 12, including the steps of:
re-inverting said receptacle and said closure;
removing said closure from said receptacle;
aseptically placing a cover over said culture medium;
and incubating said culture medium.
14. A method of diagnosing a liquid sample for the pres-ence of Neisseria gonorrhoeae, comprising the steps of:
placing a substantial quantity of the liquid sample in a receptacle;
inoculating a gonococcal culture medium with the liquid sample in the receptacle while exposing the medium to a relatively large volume of the placed liquid for at least about two minutes and permitting N. gonorrhoeae microorganisms in the sample to sufficiently settle out on the culture medium.
CA234,338A 1974-08-29 1975-08-26 Diagnostic device for liquid samples Expired CA1039633A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US49597774A 1974-08-29 1974-08-29

Publications (1)

Publication Number Publication Date
CA1039633A true CA1039633A (en) 1978-10-03

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA234,338A Expired CA1039633A (en) 1974-08-29 1975-08-26 Diagnostic device for liquid samples

Country Status (1)

Country Link
CA (1) CA1039633A (en)

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