Method and instrument for the detection of neisseria gonorrheae without culture

Claim 1

A METHOD FOR RAPID TESTING FOR NEISSERIA GONORRHEA IN THE MALE PATIENT WITHOUT CULTURE AND WITOUT GRAMSTANDING OF THIS ORGANISM, CONSISTING ESSENTIALLY OF SAMPLING THE URETHRAL EXUDATE OF A MALE PATIENT DIRECTLY ONTO A STERILE SWAB TO THEREBY PROVIDE A SPECIMEN OF EXUDATE ON SAID SWAB; BRINGING SAID SWAB INTO CONTACT WITH A POROUS ABSORBENT PLEDGET IN DRY CONDITION WHICH HAS BEEN IMPREGNATED WITH A SOLE COLORFORMING REAGENT SELECTED FROM THE GROUP CONSISTING OF PAMINO DIMETHYLANILINE OXALATE, N, N-DIMETHYL-PPHENYLENEDIAMINE DIHYDROCHLORIDE, N, N-DIMETHYL-PPHENYLENEDIAMINE OXALATE, N, N-DIMETHYL-P-PHENYLENE DIAMINE MONOHYDROCHLORIDE AND N, N, N'' N'' TETRA-METHYL-PPHENYLENEDIAMINE DIHYDROCHLORIDE, WHICH HAS BEEN PLACED IN A TUBE OF TRANSPARENT PLASTIC HAVING FLEXIBLE SIDE WALLS AND A CLOSED END; PROVIDING A FRANGIBLE AMPUL IN SAID TUBE CONTAINING PHYSIOLOGICAL SALT SOLUTION AT PH 6.5 TO 7.2 AS A WETTING ACTIVATING AGENT FOR REAGENT IN SAID PLEDGET WHICH IS LOCATED ADJACENT SAID PLEDGET AT THE END OF SAID TUBE; SAID IMPREGNATED PLEDGET IN THE DRY STATE BEING POSITIONED ABOVE SAID FRANGIBLE AMPUL AND BEING SUBSTANTIALLY COLORLESS BEFORE SAID AMPUL HAS BEEN BROKEN; AND MANUALLY SQUEEZING SAID TUBE AT THE FLEXIBLE SIDE WALLS NEAR THE CLOSED END ADJACENT SAID FRANGIBLE AMPUL TO BREAK AND TO RELEASE SAID WETTING ACTIVATING REAGENT THEREBY WETTING SAID PLEDGET AND SWAB WITH SPECIMEN WITH SAID LIQUID WETTING ACTIVATING AGENT TO PRODUCE A COLOR CHANGE ON THE SPECIMEN OF EXUDATE ON THE SWAB WHEN NEISSERIA GONORRHEAE IS PRESENT, THE COLOR RESULTING FROM CONTACT BETWEEN SAID SPECIMEN ON SAID SWEB WETTED BY SAID WETTING ACTIVATING ATENT WHICH TRANSPORTS THE REAGENT FROM THE PLEDGET TO THE SWAB REACTING WITH THE NEISSERIA GONORRHEAE PRESENT IN THE SPECIMEN AND PRODUCING A COLOR CHANGE NORMALLY TO PURPLE, REDORANGE OR DARK GREY, INDICATING A POSITIVE TEST OF NEISSERIA GONORRHEAE IS SAID SPECIMEN, THE FRAGMENTED MATERIAL FROM THE AMPUL BEING RETAINED WITHIN SAID TUBE AND THE COLOR BEING OBSERVED WITHIN 30 TO 120 SECONDS.

Claim 2

A METHOD FOR RAPID TESTING FOR NEISSERIA GONORRHEA IN THE MALE PATIENT WITHOUT CULTURE AND WITOUT GRAMSTANDING OF THIS ORGANISM, CONSISTING ESSENTIALLY OF SAMPLING THE URETHRAL EXUDATE OF A MALE PATIENT DIRECTLY ONTO A STERILE SWAB TO THEREBY PROVIDE A SPECIMEN OF EXUDATE ON SAID SWAB; BRINGING SAID SWAB INTO CONTACT WITH A POROUS ABSORBENT PLEDGET IN DRY CONDITION WHICH HAS BEEN IMPREGNATED WITH A SOLE COLORFORMING REAGENT SELECTED FROM THE GROUP CONSISTING OF PAMINO DIMETHYLANILINE OXALATE, N, N-DIMETHYL-PPHENYLENEDIAMINE DIHYDROCHLORIDE, N, N-DIMETHYL-PPHENYLENEDIAMINE OXALATE, N, N-DIMETHYL-P-PHENYLENE DIAMINE MONOHYDROCHLORIDE AND N, N, N'' N'' TETRA-METHYL-PPHENYLENEDIAMINE DIHYDROCHLORIDE, WHICH HAS BEEN PLACED IN A TUBE OF TRANSPARENT PLASTIC HAVING FLEXIBLE SIDE WALLS AND A CLOSED END; PROVIDING A FRANGIBLE AMPUL IN SAID TUBE CONTAINING PHYSIOLOGICAL SALT SOLUTION AT PH 6.5 TO 7.2 AS A WETTING ACTIVATING AGENT FOR REAGENT IN SAID PLEDGET WHICH IS LOCATED ADJACENT SAID PLEDGET AT THE END OF SAID TUBE; SAID IMPREGNATED PLEDGET IN THE DRY STATE BEING POSITIONED ABOVE SAID FRANGIBLE AMPUL AND BEING SUBSTANTIALLY COLORLESS BEFORE SAID AMPUL HAS BEEN BROKEN; AND MANUALLY SQUEEZING SAID TUBE AT THE FLEXIBLE SIDE WALLS NEAR THE CLOSED END ADJACENT SAID FRANGIBLE AMPUL TO BREAK AND TO RELEASE SAID WETTING ACTIVATING REAGENT THEREBY WETTING SAID PLEDGET AND SWAB WITH SPECIMEN WITH SAID LIQUID WETTING ACTIVATING AGENT TO PRODUCE A COLOR CHANGE ON THE SPECIMEN OF EXUDATE ON THE SWAB WHEN NEISSERIA GONORRHEAE IS PRESENT, THE COLOR RESULTING FROM CONTACT BETWEEN SAID SPECIMEN ON SAID SWEB WETTED BY SAID WETTING ACTIVATING ATENT WHICH TRANSPORTS THE REAGENT FROM THE PLEDGET TO THE SWAB REACTING WITH THE NEISSERIA GONORRHEAE PRESENT IN THE SPECIMEN AND PRODUCING A COLOR CHANGE NORMALLY TO PURPLE, REDORANGE OR DARK GREY, INDICATING A POSITIVE TEST OF NEISSERIA GONORRHEAE IS SAID SPECIMEN, THE FRAGMENTED MATERIAL FROM THE AMPUL BEING RETAINED WITHIN SAID TUBE AND THE COLOR BEING OBSERVED WITHIN 30 TO 120 SECONDS.

Claim 4

A method for rapid testing for Neisseria Gonorrheae in the male patient without culture and without gram-staining of this organism, consisting essentially of sampling the urethral exudate of a male patient directly onto a sterile swab to thereby provide a specimen of exudate on said swab; bringing said swab into contact with a porous absorbent pledget in dry condition which has been impregnated with a sole color-forming reagent selected from the group consisting of p-Amino Dimethylaniline Oxalate, N, N-Dimethyl-p-Phenylenediamine Dihydrochloride, N, N-Dimethyl-p-Phenylenediamine Oxalate, N, N-Dimethyl-p-Phenylenediamine Monohydrochloride and N, N, N'' N'' Tetra-Methyl-p-Phenylenediamine Dihydrochloride, which has been placed in a tube of transparent plastic having flexible side walls and a closed end; providing a frangible ampul in said tube containing a wetting activating agent consisting of water at pH 6.5 to 7.2 which is located adjacent said pledget at the end of said tube; said impregnated pledget in the dry state being positioned in contact with said frangile ampul and being substantially colorless before said ampul has been broken; and manually squeezing said tube at the flexible side walls near the closed end adjacent said frangible ampul to break and release said water at pH 6.5 to 7.2 thereby wetting said pledget and swab with specimen to produce a color change on the specimen of exudate on the swab when Neisseria gonorrheae is present, the color resulting from contact between said specimen on said swab wetted by water which transports the reagent from the pledget to the swab reacting with the Neisseria gonorrheae present in the specimen and producing a color change normally to purple, red-orange or dark grey, indicating a positive test of Neisseria gonorrheae in said specimen, the fragmented material from the ampul being retained within said tube and the color being observed within 30 to 120 seconds.

Claim 5

A method for rapid testing for Neisseria Gonorrheae in the male patient without culture and without gram-staining of this organism, consisting essentially of sampling the urethral exudate of a male patient directly onto a sterile swab to thereby provide a specimen of exudate on said swab; bringing said swab into contact with a porous absorbent pledget in dry condition which has been impregnated with a sole color-forming reagent selected from the group consisting of p-Amino Dimethylaniline Oxalate, N, N-Dimethyl-p-Phenylenediamine Dihydrochloride, N, N-Dimethyl-p-Phenylenediamine Oxalate, N, N-Dimethyl-p-Phenylenediamine Monohydrochloride and N, N, N'' N'' Tetra-Methyl-p-Phenylenediamine Dihydrochloride, which has been placed in a tube of transparent plastic having flexible side walls and a closed end; providing a frangible ampul in said tube containing a wetting activating agent consisting of water at pH 6.5 to 7.2 which is located adjacent said pledget at the end of said tube; said impregnated pledget in the dry state being positioned in contact with said frangile ampul and being substantially colorless before said ampul has been broken; and manually squeezing said tube at the flexible side walls near the closed end adjacent said frangible ampul to break and release said water at pH 6.5 to 7.2 thereby wetting said pledget and swab with specimen to produce a color change on the specimen of exudate on the swab when Neisseria gonorrheae is present, the color resulting from contact between said specimen on said swab wetted by water which transports the reagent from the pledget to the swab reacting with the Neisseria gonorrheae present in the specimen and producing a color change normally to purple, red-orange or dark grey, indicating a positive test of Neisseria gonorrheae in said specimen, the fragmented material from the ampul being retained within said tube and the color being observed within 30 to 120 seconds.