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US 4,376,634 AGranted
Assay kit having syringe, dilution device and reagents within sealed container
AssigneeMallinckrodt Inc.
InventorsRichard B. Prior, Vincent A. Spagna
Life of this patent
Estimating the term…
Abstract
A diagnostic kit for rapid presumptive diagnosis of gonococcal urethritis using Limulus lysate reagent. A urethral specimen taken by a syringe without a needle is mixed with specimen diluent carried by a sterile reservoir containing the requisite amount of diluent. After a sufficient dilution has occurred, a needle is placed on the syringe permitting delivery to a vial containing the Limulus lysate reagent. After a specified incubation period the vial is observed for gelation as the presumptive diagnostic test for gonococcal urethritis.
Claims42
A diagnostic kit comprising
- (a) a syringe having a tip with an opening for extracting a specimen to be tested under negative pressure and expelling said specimen under positive pressure;
- (b) a sealed dilution device containing a preselected quantity of sterile, pyrogen-free diluent for diluting said specimen, said dilution device having an opening for providing access to said sterile, pyrogen-free diluent;
- (c) a needle fixable to the tip of said syringe;
- and
- (d) a vial containing reagents for an assay, said vial having a septum penetrable by said needle;
- wherein said tip is engageable with said dilution device for receiving sterile, pyrogen-free diluent from said dilution device and said needle is of a sufficient length to pass through said septum and provide a path to said reagents for an assay contained in said vial for diluted specimen.
3 more elements
A method for diagnostic test comprising:
- (a) taking a specimen of the material to be tested with a syringe having an end portion for placing in the area where the specimen exists and a plunger portion for imparting a negative or positive pressure, pulling said plunger to impart negative pressure to draw a specimen into said syringe;
- (b) providing a preselected amount of sterile, pyrogen-free diluent in a container which has an opening for access to the container and a closure for sealing said opening;
- (c) removing said closure to expose said opening within said container;
- (d) placing said end portion of said syringe with the specimen therein into said opening with sufficient force to seal the path between the sterile, pyrogen-free diluent container and the syringe, diluting the specimen by expelling the specimen into the sterile, pyrogen-free diluent container and withdrawing the diluted specimen into the syringe, removing the syringe from the sterile, pyrogen-free diluent container, with a selected amount of diluted specimen in said syringe;
- (e) placing a needle on the end portion of the syringe;
- (f) providing in a vial reagents for an assay for diagnosing the specimen, said vial having a septum portion penetrable by said needle;
- (g) pushing said needle through said septum and expelling said diluted specimen into said vial by pressing said plunger downwardly and providing positive pressure on the specimen;
- and
- (h) observing said specimen and reagents for an assay for a signal to indicate positive or negative results.
6 more elements
A diagnostic kit comprising:
- (a) a specimen-collecting means for extracting exudate under negative pressure and expelling said specimen under positive pressure;
- (b) a sealed dilution device including a container containing a preselected quantity of sterile, pyrogen-free diluent for diluting said specimen, said dilution device having an opening for providing access to said sterile, pyrogen-free diluent;
- and
- (c) a vial containing reagents for an assay having a resealable opening configured to receive the diluted specimen in sealed relationship with said specimen-collecting means for sealing the diluted specimen and reagents for the assay from the surrounding atmosphere;
- wherein said dilution device opening has a frangible seal sealing said sterile, pyrogen-free diluent within said container and said specimen-collecting means is configured to engage said dilution device in sealed relationship therewith at said dilution device opening to receive said sterile, pyrogen-free diluent from said container sealed from the surrounding atmosphere.
2 more elements
A method for diagnostic test comprising:
- (a) taking a specimen of material to be tested under negative pressure;
- (b) providing a preselected amount of sterile, pyrogen-free diluent in a container which has an opening for access sealed by a frangible membrane;
- (c) breaking said frangible membrane to obtain access to the sterile, pyrogen-free diluent within said container;
- (d) diluting the specimen by expelling the specimen under positive pressure through said opening and in sealed relationship with said membrane to seal the path for the specimen from the surrounding atmosphere;
- (e) withdrawing a preselected amount of diluted specimen from said container while sealed from the surrounding atmosphere;
- (f) providing in a vial reagents for an assay for diagnosing a specimen, said vial having a resealable opening for receiving diluted specimens;
- (g) delivering the diluted specimen to said vial in sealed relationship with said resealable opening and expelling said diluted specimen into said vial sealed from the surrounding atmosphere;
- and
- (h) observing said specimen and reagents for an assay for a signal to detect positive or negative results.
6 more elements
A diagnostic kit comprising:
- (a) a specimen-collecting means including a body for extracting exudate under negative pressure and expelling said specimen under positive pressure;
- (b) a hollow shaft having at one end a base for releasably securing said shaft to said body and having at the other end an absorbent pad for absorbing the specimen;
- (c) a sealed dilution device including a container containing a preselected quantity of sterile, pyrogen-free diluent for diluting said specimen, said dilution device having an opening for providing access to said sterile, pyrogen-free diluent;
- (d) a frangible seal for covering said opening and sealing said sterile, pyrogen-free diluent within said container;
- (e) said specimen-collecting means being configured to engage said dilution device in sealed relationship therewith at said opening to receive sterile, pyrogen-free diluent from said container sealed from surrounding atmosphere;
- and
- (f) a vial containing reagents for an assay, said vial having a resealable opening configured to receive diluted specimen in sealed relationship with said specimen-collecting means for sealing the diluted specimen and reagents for the assay from surrounding atmosphere.
4 more elements
A diagnostic kit comprising:
- (a) a syringe having a tip with an opening for drawing therethrough a specimen to be tested under negative pressure and expelling therethrough said specimen under positive pressure;
- (b) a hollow shaft having at one end a base for releasably securing said shaft to said tip of the syringe and having at the other end an absorbent pad for absorbing the specimen;
- (c) a sealed dilution device for containing a preselected quantity of sterile, pyrogen-free diluent for diluting said specimen, said dilution device having an opening for providing access to said sterile, pyrogen-free diluent;
- (d) a needle affixable to the tip of said syringe;
- and
- (e) a vial containing reagents for an assay, said vial having a septum penetrable by said needle;
- wherein said base of said shaft is engageable with said dilution device for extending said shaft into said dilution device to provide a path through the pad and hollow shaft for sterile, pyrogen-free diluent contained in said dilution device and said needle is of a sufficient length to pass through said septum and provide a path to said reagents for an assay contained in said vial for diluted specimen.
4 more elements
A diagnostic kit comprising:
- (a) a specimen-collecting means for obtaining a specimen and subjecting the specimen alternately to negative pressure and positive pressure;
- (b) a sealed dilution device including a container containing a preselected quantity of sterile, pyrogen-free diluent for diluting said specimen, said dilution device having an opening for providing access to said sterile, pyrogen-free diluent;
- (c) said opening having a frangible seal sealing said sterile, pyrogen-free diluent within said container;
- (d) a needle having a base member for securing said needle to said specimen-collecting means, said base member being configured for engaging said dilution device in sealed relationship therewith at said opening to permit passage of sterile, pyrogen-free diluent from said container into said collecting means sealed from surrounding atmosphere;
- and
- (e) a vial containing reagents for an assay, said vial having a resealable opening for sealing relationship with said needle when penetrated thereby to expel diluted specimen into said vial.
3 more elements
A diagnostic kit comprising:
- (a) a specimen-collecting means including a hollow body for extracting exudate under negative pressure and expelling said specimen under positive pressure;
- (b) a hollow shaft having at one end a base for releasably securing said shaft to said body and having at the other end an absorbent pad for absorbing the specimen;
- (c) a sealed dilution device including a container containing a preselected quantity of sterile, pyrogen-free diluent for diluting said specimen, said dilution device having an opening for providing access to said sterile, pyrogen-free diluent;
- and
- (d) a vial containing reagents for an assay;
- wherein said opening has a frangible seal sealing said sterile, pyrogen-free diluent within said container, said specimen-collecting means is configured to engage said dilution device in sealed relationship therewith at said opening to receive sterile, pyrogen-free diluent from said container sealed from surrounding atmosphere, said body of the specimen-collecting means has a tip at one end thereof and a needle for being secured to said tip of said specimen-collecting means, said vial has a septum for sealing relationship with said needle when penetrated by the needle such that the collected diluted specimen can be expelled within said vial after having penetrated the septum in sealing relationship therewith, and said needle has an adapter on one end thereof for securing said needle to said hollow body, said base of said hollow shaft is configured for releasably securing said shaft to said adapter.
3 more elements
A method for diagnostic test comprising:
- (a) taking a specimen of material to be tested under negative pressure;
- (b) providing a preselected amount of sterile, pyrogen-free diluent in a container which has an opening for access sealed by a frangible membrane;
- (c) breaking said frangible membrane to obtain access to the sterile, pyrogen-free diluent within said container;
- (d) diluting the specimen by expelling the specimen under positive pressure through said opening and in sealed relationship with said membrane to seal the path for the specimen from the surrounding atmosphere;
- (e) withdrawing a preselected amount of diluted specimen from said container while sealed from the surrounding atmosphere;
- (f) providing in a vial reagents for an assay for diagnosing a specimen, said vial having a resealable opening for receiving diluted specimen;
- (g) delivering the diluted specimen to said vial in sealed relationship with said resealable opening and expelling said diluted specimen into said vial sealed from the surrounding atmosphere;
- (h) observing said specimen and reagents for an assay for a signal to detect positive or negative results;
- (i) said steps for collecting specimen under negative pressure and expelling specimen under positive pressure include providing an elongated hollow body with a plunger therein movable within said body portion and having one end open for collecting and expelling said specimen and another end from which extends said plunger for operation by user whereby pressing of said plunger towards said one end provides positive pressure for expelling specimen and retracting of said plunger toward the other end provides negative pressure for collecting a specimen;
- and
- (j) said hollow body including a tip, a needle is affixed to the tip prior to breaking the frangible membrane, and the frangible membrane being broken by inserting the needle into the opening for the sterile, pyrogen-free diluent container.
8 more elements
A method for diagnostic test comprising:
- (a) taking a specimen of material to be tested by absorbing the specimen on an absorbent pad located on the end of a hollow shaft;
- (b) providing a preselected amount of sterile, pyrogen-free diluent in a container which has an opening for access sealed by a frangible membrane;
- (c) breaking the frangible membrane to obtain access to the sterile, pyrogen-free diluent within said container;
- (d) diluting the specimen by inserting the absorbent pad into the sterile, pyrogen-free diluent container and drawing sterile, pyrogen-free diluent under negative pressure through the pad and expelling drawn sterile, pyrogen-free diluent under positive pressure through the pad to the container while sealed from the surrounding atmosphere;
- (e) withdrawing a preselected amount of diluted specimen from said container while sealed from the surrounding atmosphere;
- (f) providing in a vial reagents for an assay for diagnosing a specimen, said vial having a releasable opening for receiving diluted specimen;
- (g) delivering the diluted specimen to said vial in sealed relationship with said resealable opening and expelling said diluted specimen into said vial sealed from the surrounding atmosphere;
- and
- (h) observing said specimen and reagents for an assay for a signal to detect positive or negative results.
6 more elements
Dependencies are inferred from the claim text.