Microbial (non-fermentative bacteria) identification and drug sensitivity analysis system test plate (colorimetric/turbidimetric method)

User Manual (V1.0)

【Product name] Common name: Microbial (non-fermentative bacteria) identification and drug susceptibility analysis system test board (colorimetric/turbidimetric method)

[Packaging Specifications] 10 servings/box.

【Intended use】 For the identification of non-fermentative bacteria and semi-quantitative analysis of antimicrobial MIC.

【Inspection Principle】

     The system test plate is composed of biochemical reaction wells and antibacterial drug MIC determination test wells. Bacterial suspension is added to the biochemical reaction wells, and bacterial drug susceptibility medium is added to the antibacterial drug MIC determination test wells. After incubation at 35~37 °C, the biochemical reaction is at Under the action of bacterial metabolism, the color changes directly or after the addition of auxiliary reagents. The antibacterial drug MIC determination test determines whether there is bacterial growth according to whether the test hole appears turbid (precipitation). , Accurately identify the species and analyze the MIC value of antibacterial drugs.

【Main components】 Kit composition:

  1. Microbial (non-fermentative bacteria) identification and drug sensitivity analysis system test board 10 pieces

  2. 1 copy of the manual

  3. Diluent 10 pieces

  4. M-H broth medium 10 sticks

  Note 1. Reagents in different batches of kits cannot be used interchangeably.

  2. Not included in the product, but the necessary reagent components for this test: auxiliary reagents (nitrate reducing reagent A, nitrate reducing reagent B, sterile paraffin oil, indigo base reagent)

【Storage conditions and validity period】 Store at 2-8°C; validity period is 12 months.

【Applicable instruments】 Microbial identification drug sensitivity analysis system.

【Sample requirements]】 The tested bacteria using this test board should meet the following three requirements:

1. Gram-negative bacilli without special nutritional requirements;

2. The oxidase test is positive, or the oxidase is negative but anaerobic glucose does not produce acid;

3. A single pure colony (or pure culture) isolated and cultured for 18-24 hours

【Testing method】

　   Biochemical test operation method:

1. Preparation of bacterial suspension: Pick a single colony of pure culture and grind it on the inner wall of the diluent bottle to form a bacterial suspension (0.5 McFarland units).

2. Use a continuous pipette (with a sterile tip) to draw the bacterial solution into wells A1-A12 and B1-B12 of the test plate, 100 μl per well.

(Quick sample addition: pour the bacterial suspension into the groove on the right side of the test plate, install 6 sterile tips with an 8-channel pipette, and draw the bacterial solution in 4 times.

Put it into wells A1-A12 and B1-B12 of the test plate, 100 μl per well. )

3. Add 2 drops of sterile paraffin oil to wells A1-A7 respectively.

　    Drug susceptibility test operation method:

1. Aspirate 50 μl of the bacterial suspension, add it to the M-H broth medium and mix, and continue to add 100 μl to the remaining wells of the test plate (all drug-susceptible wells and growth control wells C+ and 6.5% NaCl).

(Quick sample addition: Aspirate 50μl of bacterial suspension, add it to the M-H broth medium, mix well, pour it into the left groove of the test plate, and continue to use an 8-channel pipette to add 2 more tips for a total of 8 , Add 12 times to the drug-sensitive wells of the test plate. Each well is 100 μl.)

2. Immerse the remaining bacterial solution and the tip in the sterilizing solution for sterilization.

3. Tear off the self-adhesive paper (align the holes) and stick it on the identification plate (attach the grooves on both sides of the identification plate as well), incubate at 35~37°C for 18-24 hours, and interpret the results.

【Explanation of test results】

First add two drops of indigo matrix reagent in well A11 (IND), and then add one drop of nitrate reducing reagent A and B in well A10 (NIT) after a few minutes, and read the result immediately.

2. Analyze the test plate with the microbial identification drug susceptibility analysis system. After the analysis is completed, the bacterial species and MIC semi-quantitative results will be automatically determined, and the report will be printed (the detailed operation of the microbial identification drug susceptibility analysis system will be introduced separately).

【Limitations of the test method】

The identification of drug susceptibility analysis system is to identify bacteria according to the background data of the database. Incomplete database data will directly affect the accuracy of identification.

【Product performance index】

1. Accuracy rate: The accuracy rate of the system test board for the identification of the quality control strains should be 100%; the accuracy rate of the system test board for the determination of the MIC of the quality control strains should be 100%.

2. Repeatability: The repeatability of the system test board for the identification of quality control strains should be 100%; the repeatability of the system test board for the MIC determination of quality control strains should be 100%.

3. Intra-assay imprecision: There should be no difference in the intra-assay imprecision of the quality control strains identified by the system test plate. There should be no difference in the intra-assay imprecision of the system test plate for the determination of the antimicrobial drug MIC of the quality control strains.

4. Inter-batch imprecision: There should be no difference in the batch-to-batch imprecision of the system test plate for the identification of quality control strains; there should be no difference in the batch-to-batch imprecision of the system test plate for the MIC determination of the quality control strains.

【Precautions】

1. All operations should avoid bacterial contamination.

2. Solitary cholerae must be tested for slide agglutination with diagnostic serum immediately and reported promptly within the specified time.

3. The identification test outside the plate must be done in advance, that is, Gram stain microscopy and oxidase test (if necessary, the power should also be observed). sexual error.

4. The tested bacteria must be fresh and pure culture, strictly avoid using two or more colonies or using old cultures for testing.

5. The reaction results after 48 hours of incubation cannot be used as a basis for judgment.

6. The substrates of each well of this test plate are freeze-dried under sterile conditions, sealed and packaged, and then pre-warmed at room temperature before opening in a sterile environment.

7. Necessary protective measures must be taken during the operation to prevent the operator from being infected, and the waste should be treated as a source of infection.

8. This product is only used for in vitro diagnosis and is for one-time use. It is forbidden to use the reagent plate package if there is air leakage or damage, and abnormal phenomena such as turbidity and precipitation in the diluent and medium bottle should not be used.

9. Please read this manual carefully before use.

【Explanation of the logo】

   ：In vitro diagnostic medical devices.

  ：Refer to the instructions for use.

  ：Not to be used twice.

【references】

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

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

  3. "National Clinical Inspection Operating Regulations"

  4. "Clinical and Laboratory Standards Institute" document

【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