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Mycoplasma Identification Medium (Microbial Culture Method) Instruction Manual

Mycoplasma Identification Medium (Microbial Culture Method) Instruction Manual

(Summary description)

Mycoplasma Identification Medium (Microbial Culture Method) Instruction Manual

(Summary description)

Information

Mycoplasma identification medium (microbial culture method)

User Manual (V1.0)

【Product name】 Common name: Mycoplasma identification medium (microbial culture method)

【Product Specifications】 20 servings/box.

【Intended use】 It is suitable for the isolation and identification of Ureaplasma urealyticum, Mycoplasma hominis and Mycoplasma pneumoniae.

【Test principle】The medium contains mycoplasma basal broth, horse serum, yeast extract, phenol red indicator, mixed antibiotics, urea, arginine, glucose and other substances. When Uu or Mh grows, the urea or arginine in the medium is decomposed, and the generated alkaline substances cause the pH value to rise, and the medium changes from yellow to red. When Mp grows, the glucose in the medium is decomposed, and the generated acidic substances reduce the pH, the medium changes from red to yellow, and the medium is added with bacteriostatic agents, which can inhibit the growth of bacteria and fungi in the reproductive tract. It has high sensitivity, strong specificity, simple operation and reliable results.

【Main components】

1. Mycoplasma identification medium 20 pieces

2. 1 copy of the instruction manual

The main components of the medium: each liter of medium contains 25.5g of basal powder, 150 ml of horse serum, 4g of yeast powder, 0.5 ml of 4g/L phenol red, and 1.5 ml of mixed antibiotics.

【Storage conditions and validity period】 Store frozen below 0°C, valid for 12 months.

【Sample requirements】

Specimens must be taken before medication. Mycoplasma has a strong affinity for the cell surface. As many cells as possible should be collected. Specimens should be inoculated as soon as possible after collection. die.

Male: Use male sterile swab to take urethral secretions from 1-2 cm from the anterior urethra. According to the needs of the disease, prostate massage fluid and semen can also be taken.

Women: When taking cervical specimens, the excess mucus should be wiped off the cervix first, and the cervical secretions should be taken from the 1-2 cm of the cervical canal with a female swab, and then another swab should be used to obtain the material. When taking the swab, rotate and hold in the cervix (or urethra) for at least 20 seconds to obtain more cells.

If it is necessary to use urine for mycoplasma culture, 10-20ml of urine can be collected in the middle of the morning. After high-speed centrifugation, the sediment is inoculated, but the positive rate of urine mycoplasma culture is significantly lower than that of urethral (or cervical) secretions.

Specimens for culture of Mycoplasma pneumoniae are throat swabs, throat swabs, sputum (or tracheal secretions).

【Testing method】

1. The medium was removed from the refrigerator and kept at room temperature so that the medium was close to room temperature.

2. Insert the collected specimen swab into the culture bottle, and squeeze and rotate the swab several times on the bottle wall near the liquid surface to infiltrate the sample in the swab.

3. For semen and prostatic fluid samples, add 200 μl to the medium; for midstream urine, centrifuge at 2000 rpm for 10 minutes, and add 100 μl of the sediment to the medium.

4. Tighten the lid, put it in the incubator at 35℃~37℃, and observe the result in 24h~72h.

【Explanation of test results】

Ureaplasma urealyticum and Mycoplasma hominis medium becomes clear and transparent red is positive, and the medium does not change color (yellow or orange) is negative, the results are observed within 24 hours of Ureaplasma urealyticum medium, and the results of Mycoplasma hominis medium are observed within 48 hours .

Mycoplasma pneumoniae culture medium becomes clear and transparent yellow, it is positive, and the medium does not change color (red), it is negative. Negative specimens can be cultured for 72 hours, and the medium still does not change color, and it is judged as negative.

【Limitations of the test method】

1. The test results largely depend on the collection of specimens, so a negative result does not confirm that there is no infection.

2. A positive result indicates the presence of Mycoplasma in the urogenital tract, but it cannot be used as a sufficient basis for clinical diagnosis. Clinical diagnosis requires a combination of laboratory test results and clinical symptoms.

【Product performance index】

1. Accuracy:

Ureaplasma urealyticum identification medium was 100% accurate for the identification of U. urealyticum standard strain ATCC27813.

The accuracy rate of Mycoplasma hominis identification medium for the identification of Mycoplasma hominis standard strain ATCC14027 was 100%.

Mycoplasma pneumoniae identification medium has an accuracy rate of 100% for the identification of Mycoplasma pneumoniae standard strain ATCC15531.

2. Repetition rate:

Ureaplasma urealyticum identification medium was 100% reproducible for the identification of Ureaplasma urealyticum standard strain ATCC27813.

The reproducibility of Mycoplasma hominis identification medium for the identification of Mycoplasma hominis standard strain ATCC14027 was 100%.

The reproducibility of Mycoplasma pneumoniae identification medium for the identification of Mycoplasma pneumoniae standard strain ATCC15531 was 100%.

3. Intraassay Imprecision: There should be no difference.

4. Inter-assay imprecision: There should be no difference.

【Precautions】

1. Please pay attention to the validity period and use it within the validity period.

2. Women during menstruation and threatened abortion are prohibited; it is prohibited after vaginal medication or lavage.

3. Read the instructions carefully before use. If the medium turns red, turbid, precipitated, or hairy before use, it should not be used.

4. Specimens should be collected correctly. When taking urethral and cervical secretions, a swab slightly soaked in sterile saline should be used to extend into the urethra or cervix for more than 1 cm, slowly twist the swab and stay for at least 20 seconds to obtain the swab there. Epithelial cells, timely inoculation of medium and standardized operating procedures are the keys to improving the positive detection rate and accuracy.

5. The growth of mycoplasma should keep the medium transparent and clear, and the turbidity and redness caused by the contamination of miscellaneous bacteria should not be reported as positive for mycoplasma (but some samples with more secretions, inoculation into the medium may cause the clarity of the medium to decrease, please pay attention to the difference).

6. When the culture medium is red but obviously turbid, it should be centrifuged at 3000 rpm for 10 minutes, and the supernatant should be transferred to another tube of culture medium. If necessary, inoculate solid medium, observe with low magnification microscope after incubation, and those with (fried egg)-like colonies are positive.

7. The medium should be stored frozen below 0°C, and the performance of the medium will decrease if the temperature is too high.

8. This product is only used for in vitro diagnosis and is for one-time use. If it is damaged, please do not use it.

9. The operation process must have the necessary protective measures to prevent the operator from being infected. Waste should be treated as a source of infection.

【Explanation of the logo】

   18.png:In vitro diagnostic medical devices.

   19.png:Refer to the instructions for use.

   20.png:Not to be used twice

【references】

    1. Patrick R.Murray, Mannal of clinical Microbiology, 7th edition.

    2. Glatt,A.E.,W.M.Mc Cormack. and D. Taylor-Robison 1989. Genital mycoplasma , P279-293 in sexually  

       Transmitted Disease,2nd , McGraw-Hill Book co., New York, N.Y.

   3. Wen Yumei, Modern Medical Microbiology, First Edition, Shanghai Medical University Press.

   4. Compiled by Wang Xiancai, Contemporary STD Diagnosis and Treatment, First Edition, Qingdao Publishing House.

   5. Ye Shunzhang, Laboratory Diagnosis of Sexually Transmitted Diseases, 1st Edition, Science Press.

【Basic Information】

Name of the registrant/manufacturer: Zhuhai Meihua Medical Technology Co., Ltd.

Address: Unit 3B-3, 3rd Floor, Annex Building, Building 10, Science and Technology 1st Road, Gangwan Avenue, Tangjiawan Town, Zhuhai City

Contact: (0756) 3865699

Postcode: 519085

Tel: (0756) 3865688 Fax: (0756) 3865669

http://www.meihuayl.com 

Name of after-sales service unit: Zhuhai Meihua Medical Technology Co., Ltd.

Contact: 400-603-1358

Production address: Unit 3B-3, 3rd Floor, Annex Building, Building 10, Science and Technology 1st Road, Gangwan Avenue, Tangjiawan Town, Zhuhai City

Production license number: Guangdong Food and Drug Administration Production Xu No. 20081652

【Medical device registration certificate number/product technical number】

Medical device registration certificate number:

Product technical requirement number:

【Approval date and revision date of the specification】 June 1, 2015

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© 2022  Zhuhai Meihua Medical Technology Co., Ltd.  All rights reserved.   粤ICP备2022023050号   SEO

© 2022  Zhuhai Meihua Medical Technology Co., Ltd.  All rights reserved.   粤ICP备2022023050号   SEO