SE414410B - AGENTS FOR PAVISANING NEISSERIA GONORRHEAE THROUGH ITS OXIDA ACTIVITY - Google Patents

Description

.721z927-2, 2 10 25 35 HO aids that facilitate the choice of drug treatment for the physician.

The need for a simple and inexpensive diagnostic system that can work in the field, independent of bacteriological and microscopic tests is beyond doubt. One of the difficulties in providing a rapid and reliable diagnosis of infections in men is that in the initial stages there is a confusing resemblance to urethritis.

Urethral discharge in men can occur due to the following other causes: prostatitis, trauma, Escherichia coli, staphylococci, tuberculosis, balanitis, ingested urethral irritants, cantharidin, vegetables rich in oxalates and other things that can cause urethral inflammation. Pellagra, diabetes and gout can in some cases be the cause. Trichomonas vaginalís can be found in considerable amounts in abacterial urethritis. Entamoeba histolytica as a cause of urethral secretion occurs only in the presence of a recto-urethral or vesical fistula.

Bilharzia is a metazoa that causes urethritis quite often in endemic areas. Systemic diseases such as typhoid, mumps, influenza and chickenpox can, if they are septicemic, cause urezritis.

'In a percentage of individuals with chronic urethral discharge, even if they are suspected of having a gonorrhea infection, it is not possible to detect Neisseria. Many of these are treated as gonococcal infections and it is only when they survive after a number of therapeutic treatments that the abacterial nature can be recognized.

Subsequent careful examination of the entire anterior and posterior urethra and upper urinary tract may reveal that there are signs of inflammation but that structural malformations are not pre-dispositional and furthermore that etiological organisms are completely absent.

It has been estimated that 80 percent of non-specific urethrids are abacterial. Two forms are prevalent: the acute type, similar to acute gonorrhea, and the subacute type or Welsch 'type. Abacterial pyuric conditions of the prostate and upper urinary tract have been known for a long time, and sometimes urethritis is associated with symptoms that can be attributed to the upper urinary tract. The acute abacterial urethritis usually begins one to five days after the connection. Abundant, purulent discharge occurs while the meatus turns red during simultaneous dysuria. Impact on the posterior urethra can be indicated by frequency, urgency and finally hematuria. The clinical picture is so similar to that given by gonorrhea that it is puzzling as Neisseria cannot be demonstrated.

The differential diagnosis of a urethral discharge is based on the exclusion of the urethrids that appear in gonorrhea as a first step, depending on the choice of reagent used. The compress that is in 7213927-2 3 1 secondarily on other bacteria, foreign bodies, trauma, local neoplastic and specific inflammatory diseases, hypersensitivity reactions, urethral symptoms of systemic diseases and infestations of protozoa, metazos and fungi.

The present invention therefore relates to a means for detecting Neisseria gonorrhea without gram staining or culture. This agent is characterized by a sterile fibrous tip swab for collecting a secretion sample from a patient and a transparent plastic tube with flexible side walls and a closed end, in which is placed a dry, absorbent compress impregnated with a p-phenylenediamine, which reacts with Neisseria gonorrhea causing a discoloration, and a lightly crushed ampoule containing an aqueous medium activating the p-phenylenediamine.

It is suitable that the p-phenylenediamine consists of p-amino-dimethyl-aniline oxalate, N, N-dimethyl-p-phenylenediamine dihydrochloride, N, X--dimethyl-p-phenylenediamine oxalate, N, N-dimethyl -p-phenylenediamine monohydrochloride or N, N, N ', N'-tetramethyl-p-phenylenediamine dihydrochloride. A compress or carrier of any suitable material such as dacron fibers, cotton fibers or any other porous material is impregnated or saturated with one of these reagents under certain conditions described below and then dried. It then remains in the dry state until it is activated by the aqueous medium.

The compress is the most important component in the diagnostic system, as it contains the reactive chemical that can identify the gonococcus. In the dry state, a compress made according to this procedure is stable and can be stored for a long time. The second part of the system consists of the wetting agent which is kept separate from the compress by being enclosed in a lightly crushed ampoule. When this ampoule is crushed, the wetting agent contained therein is released, whereby the reagent in the compress is activated. The compress is brought after it has been sensitized in contact with the sample on top of the collection stick, reacts with gonococci present and causes this - in that the sample present on the sample stick assumes a characteristic almost colorless does not cause any confusing reaction as it does not as to react colorimetrically. The color change takes place in the sample collected on the test strip. The reaction time required for a positive sample is usually of the order of 30 seconds. The aqueous medium contained in the ampoule may be water, physiological saline, pH buffer solutions or any other solution or combination of solutions which enhances or sensitizes the oxidase reaction. A pH adjustment of the aqueous medium is suitable, so that autooxidation of the reagent is prevented in the compress. The preferred pH range for the aqueous medium is 6.5-7.2. For a more detailed description of the manner in which the test is performed using the indicated reagents, reference is made to the accompanying drawing, in which Fig. 1 shows a vertical view of an instrument suitable for the detection of Neisseria gonorrhea, the instrument being shown for use in a test in the form marketed as a packaged system consisting of two main parts; and Fig. 2 shows a vertical view of the instrument shown in Fig. 1 after it has been used in a test. The drawing shows a variety of instruments that can be used to perform the present test, wherein 10 is a tube of transparent, flexible plastic, in which is placed a compress 12 of cotton impregnated or saturated with reagent: and dried. The compressor rests on a lightly crushed glass ampoule located at the closed end of the tube and a sleeve 16 is placed over the open end of the tube. A sterile swab with a top 18 and a plastic shaft 20 to be used for sampling the exudate is sealed in a separate, sterile package 22, and the tube and package are packed in an envelope or other suitable container (not shown). ). Although the wall structure of the plastic tube is hot to maintain flexibility, it normally has a sufficiently rigid - substantially cylindrical shape and to allow easy insertion of the test strip after an exudate sample has been taken. The ampoule contains a suitable wetting agent, as indicated, and is easily crushed to break easily when the sides of the flexible tube are pressed inwards between the thumb and forefinger, whereby the ampoule ruptures and the liquid therein can wet the material impregnated in the compress, as normal inserted into the liquid and shards of glass when the test strip is inserted into the tube. When the specimen containing the sample comes in contact with the compress, the reaction between specimen on the swab and reagent in the compress begins immediately and, if gonococci are present, the specimen on the swab changes color, near purple, red-orange or dark gray, depending on the reagent used in the compress, thus indicating a positive test. The reaction time to indicate a positive test is usually 30 to 120 seconds. The manufacture of the compress and the preparation of an aqueous medium can be carried out, for example, as follows: 1g N, N, N ', N'-tetramethyl-p-phenylenediamine dihydrochloride are added to 35 ml of dist . water, which was heated to boiling and then allowed to cool to room temperature. Solution is achieved by rapid stirring. Then 64 ml of ethanol are added and stirred.

Cotton tape, with a width of 1.9 cm and a length of 50 cm, is then dipped in the resulting 1% solution and placed on a nylon screen in a horizontal position and allowed to air dry. The dried hand is then cut into 1, U cm long strands. These form the commnresses.

A physiological saline line is prepared by adding 0.85 g of sodium chloride to 99 ml of des. water and pH are adjusted to 7.0. This solution is the wetting agent. Lightly crushed ampoules containing 0.5 ml of this solution are prepared, as this is the amount required to properly wet the compresses of 1.9 X 1, Ä cm. 5The ampoule, with an approximate diameter of 7 mm and a length of 35 mm, is placed on the bottom of a flexible plastic tube with an approximate inner diameter of 8 mm and a length of 160 mm. A compress made as above is rolled up and pushed down into the tube so that it comes into contact with the ampoule. A telescopic sleeve with an approximate length of 65 mm is placed over the open end of the plastic tube and covers the system.

A sterile dachron top mounted on a plastic shaft of approximately 150 mm in length is packed together with the reagent system, this combination constitutes the diagnostic instrument. This sample and swab are stored separately in a special, sterile glassine packaging.

The above two units, which constitute a single package, are intended to be sold via standard pharmaceutical channels to doctors, clinics and hospitals, and the package is immediately available for a test and a quick diagnosis of the patient's condition. When a diagnostic test for gonorrhea is to be performed, the package is opened and the sterile swab can be removed from the casing and a sample of the exudate is collected on top of the swab. the sleeve is then removed from the plastic tube and the test strip is inserted with the top first into the plastic tube. The sleeve is then put on again. The flexible tube is then compressed where the ampoule is located, which is crushed and its contents released. At the same time, the telescopic sleeve is pushed down, forcing the test strip containing the sample into contact with i. 7213927-2 6 10 15 20 25 compresses. Due to this effect, the compress is also forced into the wetting agent, whereby the system is activated. If the sample on the swab turns purple within two minutes, this is a positive test for gonorrhea. The test strip can be withdrawn from the compress approximately 2.5 cm to facilitate reading of the result, ie the previous color change of the sample on the test strip. The use of this test therefore provides the physician with a rapid and safe diagnostic method in the first stage of differential diagnosis.

To further illustrate the sensitivity of this system and its ability to detect gonococci exactly at the point where the sample was collected on the specimen, this procedure was repeated and a culture of Neisseria gonorrhea was used as a representative example of an exudate according to the previous example. In this example, the test strip was used to collect a few Few colonies from an odJing in a putris bowl. E11 identical procedure was performed with the instrument. A distinct purple staining of the bacteria on the test strip could be observed within one minute. The almost colorless compress and the white background of the dachron top make the identification of the organisms on the test strip clear and distinct, just as with the exudate directly from a patient.

U.S. Patent No. 5 H50 129 discloses easily crushed ampoules for transporting reagents, but the use of this method is specifically directed to the transport of a sample to a laboratory and the use of this method to preserve the viability of bacteria until they can be cultured. while this refers to a diagnostic system that does not require culture. It's a direct test.

The diagnosis is made when the sample is collected.

Claims (4)

7 121392? -2 __W Ü ggtentkrav 1. A means of detecting Neisserin gonorrhea without gram staining or culture, characterized by a sterile, fibrous tip specimen for collecting a patient excretion sample and a transparent plastic tube with flexible sidewalls and a closed end, wherein is a dry, absorbent compress impregnated with a p-phenylenediamine, which reacts with Neisseria gonorrhea to induce a discoloration, and a lightly crushed ampoule containing an aqueous medium which activates the p-phenylenediamine. Composition according to Claim 1, characterized in that the p-phenylenediamine consists of p-amino-dimethyl-aniline oxalate, N, N-dimethyl-p-phenylenediamine dihydrochloride, N, N-dimethyl-p-phenylenediamine oxalate, N, N-dimethyl-p-phenylenedinemine monohydrochloride or N, N, N ', N' -thotrimotyl-p-phenylenedinmine dihydrochloride. Agent according to Claim 1 or 2, characterized in that the aqueous agent consists of water, physiological saline or a water-containing buffer solution with a pH in the range 6.5-7.2. Agent according to one of Claims 1 to 3, characterized in that the sterile test strip with a fibrous top is placed in a separate package. STATED PUBLICATIONS: Great Britain l 245 999 US 3 450 129 (128-2) Other publications: Nature l78 (1956), p. 703. Journal of general microbiology 25 (l96l), p. 297.