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

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

(Summary description)Microbial (Staphylococcus) identification and drug susceptibility analysis system test plate (colorimetric/turbidimetric method)

User Manual (V1.0)



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

[Packaging Specifications] 10 servings/box.

【Intended use】 It is used for the identification of Staphylococcus and the semi-quantitative analysis of MIC of antibacterial drugs.

【Inspection Principle】

The reagent plate is composed of biochemical reaction wells and antibacterial drug MIC determination test wells. Bacterial suspension is added to the biochemical reaction wells, bacterial drug susceptibility medium is added to the antibacterial drug MIC determination test wells, and incubated at 35~37℃. Under the action of 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 (Staphylococcus) identification and drug susceptibility analysis system test board 10 pieces

2. 1 copy of the manual

3. Diluent 10

4. M-H broth medium 10 sticks

Note 1. Reagents in different kits are not interchangeable.

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, nitrate reducing reagent A, nitrate reducing reagent B, paraffin oil).

[Storage conditions and validity period] Store at 2-8°C; 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 without special nutritional requirements;

2. Positive catalase test;

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 obtain a bacterial suspension (0.5 McFarland units).

2. Use a continuous pipette (with a sterile tip) to take the bacterial solution and add it to 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, draw the bacterial solution in 4 times and add it to the test plates A1-A12, B1-B12 In the well, 100 μl per well.)

3. Add 2 drops of sterile paraffin oil to holes A1, A2, A3 and A4 respectively.

Drug susceptibility test operation method:

1. Aspirate 50μl of bacterial suspension with a sterile pipette, add it to the M-H broth base and mix, and continue to add 100μl to the remaining drug-susceptible wells.

(Quick sample addition: Aspirate 50μl of bacterial suspension, add it to the M-H broth medium and 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 doses to the drug-sensitive wells of the test plate. 100 μl per well.)

2. Tear off the self-adhesive (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. First, add one drop of VP reagent A and B in well A12, after 30 minutes, add one drop of PYR reagent in well A10, and one drop of nitrate reducing reagent A and B in well A11, and immediately interpret the result.

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 based on the background data of the database. Incomplete database data will directly affect the accuracy of the identification.

【Main performance indicators】

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 fo

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

(Summary description)Microbial (Staphylococcus) identification and drug susceptibility analysis system test plate (colorimetric/turbidimetric method)

User Manual (V1.0)



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

[Packaging Specifications] 10 servings/box.

【Intended use】 It is used for the identification of Staphylococcus and the semi-quantitative analysis of MIC of antibacterial drugs.

【Inspection Principle】

The reagent plate is composed of biochemical reaction wells and antibacterial drug MIC determination test wells. Bacterial suspension is added to the biochemical reaction wells, bacterial drug susceptibility medium is added to the antibacterial drug MIC determination test wells, and incubated at 35~37℃. Under the action of 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 (Staphylococcus) identification and drug susceptibility analysis system test board 10 pieces

2. 1 copy of the manual

3. Diluent 10

4. M-H broth medium 10 sticks

Note 1. Reagents in different kits are not interchangeable.

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, nitrate reducing reagent A, nitrate reducing reagent B, paraffin oil).

[Storage conditions and validity period] Store at 2-8°C; 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 without special nutritional requirements;

2. Positive catalase test;

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 obtain a bacterial suspension (0.5 McFarland units).

2. Use a continuous pipette (with a sterile tip) to take the bacterial solution and add it to 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, draw the bacterial solution in 4 times and add it to the test plates A1-A12, B1-B12 In the well, 100 μl per well.)

3. Add 2 drops of sterile paraffin oil to holes A1, A2, A3 and A4 respectively.

Drug susceptibility test operation method:

1. Aspirate 50μl of bacterial suspension with a sterile pipette, add it to the M-H broth base and mix, and continue to add 100μl to the remaining drug-susceptible wells.

(Quick sample addition: Aspirate 50μl of bacterial suspension, add it to the M-H broth medium and 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 doses to the drug-sensitive wells of the test plate. 100 μl per well.)

2. Tear off the self-adhesive (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. First, add one drop of VP reagent A and B in well A12, after 30 minutes, add one drop of PYR reagent in well A10, and one drop of nitrate reducing reagent A and B in well A11, and immediately interpret the result.

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 based on the background data of the database. Incomplete database data will directly affect the accuracy of the identification.

【Main performance indicators】

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 fo

Information

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

User Manual (V1.0)

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

[Packaging Specifications] 10 servings/box.

【Intended use】 It is used for the identification of Staphylococcus and the semi-quantitative analysis of MIC of antibacterial drugs.

【Inspection Principle】

The reagent plate is composed of biochemical reaction wells and antibacterial drug MIC determination test wells. Bacterial suspension is added to the biochemical reaction wells, bacterial drug susceptibility medium is added to the antibacterial drug MIC determination test wells, and incubated at 35~37℃. Under the action of 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 (Staphylococcus) identification and drug susceptibility analysis system test board 10 pieces

2. 1 copy of the manual

3. Diluent 10

4. M-H broth medium 10 sticks

Note 1. Reagents in different kits are not interchangeable.

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, nitrate reducing reagent A, nitrate reducing reagent B, paraffin oil).

[Storage conditions and validity period] Store at 2-8°C; 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 without special nutritional requirements;

2. Positive catalase test;

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 obtain a bacterial suspension (0.5 McFarland units).

2. Use a continuous pipette (with a sterile tip) to take the bacterial solution and add it to 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, draw the bacterial solution in 4 times and add it to the test plates A1-A12, B1-B12 In the well, 100 μl per well.)

3. Add 2 drops of sterile paraffin oil to holes A1, A2, A3 and A4 respectively.

Drug susceptibility test operation method:

1. Aspirate 50μl of bacterial suspension with a sterile pipette, add it to the M-H broth base and mix, and continue to add 100μl to the remaining drug-susceptible wells.

(Quick sample addition: Aspirate 50μl of bacterial suspension, add it to the M-H broth medium and 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 doses to the drug-sensitive wells of the test plate. 100 μl per well.)

2. Tear off the self-adhesive (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. First, add one drop of VP reagent A and B in well A12, after 30 minutes, add one drop of PYR reagent in well A10, and one drop of nitrate reducing reagent A and B in well A11, and immediately interpret the result.

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 based on the background data of the database. Incomplete database data will directly affect the accuracy of the identification.

【Main performance indicators】

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 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 quality control strains.

【Precautions】

1. All operations should avoid bacterial contamination.

2. The identification test outside the board must be done:

A Gram stain microscopy B Catalase test C Aggregation factor test (slide method)

The above A and B are the basis for the selection of the board.

C is the "key test" for identification, and its negative and positive results must be entered to complete the identification of bacteria.

3. The tested bacteria must be fresh and pure cultures, and 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 sterile conditions, sealed and packaged, and then pre-warmed at room temperature before being opened in a sterile environment. The plate film should not be opened at will to prevent air pollution.

6. 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.

7. This product is only used for in-vitro diagnosis and is for one-time use. It is forbidden to leak or damage the package of the reagent plate, diluent and medium bottle. Do not use if there are abnormal phenomena such as turbidity and precipitation inside.

8. Please read this manual carefully before use.

【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. 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

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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