Microbial (Strep/Enterococcus) identification and drug susceptibility analysis system test plate (colorimetric/turbidimetric method)

User Manual (V1.0)

【Product name】 Common name: Microbial (Strep/Enterococcus) identification and drug susceptibility analysis system test board (colorimetric/turbidimetric method)

[Packaging Specifications] 10 servings/box.

【Intended use】 For the identification of Streptococcus and Enterococcus 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, and incubated at 35~37°C. The biochemical reaction produces a color change directly under the action of bacterial metabolism or after adding auxiliary reagents. The antimicrobial drug MIC determination test determines whether there is bacterial growth according to whether the test hole appears turbid (precipitation). Quickly and accurately identify bacteria to species and analyze the MIC value of antibacterial drugs.

【Main components】 Kit composition:

    1. Microbial (Strep/Enterococcus) identification and drug susceptibility analysis system test board 10 pieces

   2. 1 copy of the manual

3. Diluent 10 pieces

4. M-H broth medium 10 sticks

5. 10 sticks of enrichment liquid

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 (VP ​​reagent A, VP reagent B, PYR chromogenic reagent, hippurate reagent).

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

[Applicable instruments] Microbial identification and drug sensitivity analysis system.

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

1. Gram-positive cocci with no special nutritional requirements or high nutritional requirements;

2. The catalase test is negative;

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

【Testing method】

Biochemical test operation method:

1. Record the type of colony hemolysis (α-hemolysis, β-hemolysis).

2. Pick a single colony of pure culture and mix it in 0.3ml sterile water.

3. The above bacterial suspension is streaked with an inoculation ring or evenly spread on the blood plate with a sterile cotton swab.

4. For β-hemolytic streptococcus and enterococcus, larger colonies can generally be formed after 24 hours of incubation, while for other streptococci, 48 hours

Larger colonies can be formed during incubation. For some fastidious bacteria with extremely high nutritional requirements, take the colonies in the special culture medium for streptococcus (1ml) and incubate at 35~37°C for 5 hours, spread the above bacterial suspension evenly on the blood plate, and then place it at 35~35°C. Incubate at 37°C for 18-24 hours.

5. Use a sterile cotton swab to take the colony into the diluent to make a bacterial suspension (2 McFarland units).

6. Use a pipette (with a sterile tip) to draw the bacterial suspension into wells A5-A12 of the test plate, 100 μl per well.

7. Draw 500μl from the above bacterial suspension, add the enrichment solution (2.5ml), mix well, and then add the enrichment solution to wells B1-B12 of the test plate, 100μl per well.

(Quick sample addition: Pour the enrichment solution into the groove on the right side of the test plate, install 6 sterile tips with an 8-channel pipette, draw the bacterial solution in 2 times and add it to holes B1-B12 of the test plate. 100 μl.)

8. Add 2 drops of sterile paraffin oil to holes A9 and B1-B12 respectively.

Drug susceptibility test operation method:

1. Take 50μl from the remaining enrichment solution, add it to the M-H broth medium and mix, and continue to add it to the remaining drug-susceptible wells, 100μl per well.

(Quick sample addition: Take 50μl from the remaining enrichment solution, add it to the M-H broth medium and mix well, pour it into the groove on the left side of the test plate, and continue to use an 8-channel pipette to add 2 more tips (total 8), added to the drug-sensitive wells (including 6.5NC wells) of the test plate in 12 times, 100μ per well.)    

2. Tear off the self-adhesive paper (align the holes) and stick it on the identification plate (the grooves on both sides of the identification plate are also attached), incubate at 35~37℃ for 24 hours (individual slow growth can be extended to 36-48 hours), interpret the results.

【Explanation of test results】

1. Add one drop of VP reagents A and B to well A10, read after 20 minutes, then add one drop of PYR reagent to well A11, and then add one drop of hippurate reagent to well A12, and read the result within 30 minutes.

2. Analyze the reagent plate with the microbial identification drug susceptibility analysis system. After the analysis, 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 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 the 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 system test plate for the identification of quality control strains; there should be no difference in the intra-assay imprecision of the system test plate for the MIC determination of the quality control strains.

4. Inter-batch imprecision: There should be no difference in the batch-to-batch imprecision for the identification of quality control strains by the system test plate; 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. The identification test outside the plate must be done: A, Gram stain microscopy B, catalase test

The above A and B are the basis for selecting the board. If it is not done or done inaccurately, it may lead to a wrong board selection.

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

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

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

6. Necessary protective measures must be taken during operation to prevent operator infection, and waste should be treated as a source of infection.

7. 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 the dilution liquid, the turbidity and sedimentation in the culture medium bottle and other abnormal phenomena should not be used.

8. Please read this manual carefully before use.

【Explanation of the logo】

 : In vitro diagnostic medical devices.

: Refer to the instructions for use.

: Do not use it 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 Operation 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