Summary of the invention
For the deficiencies in the prior art part, the invention provides a kind of method of Bacteria Identification and Analysis of Drug Susceptibility, comprise method for determining bacteria and Analysis of Drug Susceptibility method, apply to kit, kit pallet, it is characterized in that, described method for determining bacteria is for to be placed in described kit by bacterium, observe Bacteria Identification reagent in described bacterium and described kit and produce reacted color, and be converted to numeral, described numeral is encoded, according to described numerical coding, from bacterial identification storehouse, obtain described bacteria name; Described Analysis of Drug Susceptibility method is for to be placed in described kit by target bacteria, after described target bacteria and susceptibility analytical reagent in described kit produce and reacts, and the optical density of the bacterium liquid that mensuration obtains, and then analyze the susceptibility of susceptibility.
Preferably, the described numeral that converts to comprises according to the reacted color of described generation and judges response situation, then converts numeral to according to described response situation.
In above-mentioned arbitrary scheme, preferably, describedly according to described response situation, convert numeral to and comprise according to described response situation and encoding, described response situation is positive is 1, and feminine gender is 0.
In above-mentioned arbitrary scheme, preferably, described coding comprises that three one are combined into a numeral, and then form final 5 or 6 codings according to the cryptoprinciple of BCD coding.
In above-mentioned arbitrary scheme, preferably, when described response situation is intermediary, both carry out the described coding as 1, also carried out the described coding as 0.
In above-mentioned arbitrary scheme, preferably, described bacterial identification storehouse refers to the database of producing according to the response characteristic in the biochemical hole in described kit.
In above-mentioned arbitrary scheme preferably, described in analyze susceptibility susceptibility comprise the concentration that calculates described bacterium liquid according to described optical density, then according to drug sensitivity described in described concentration and the comparative analysis of break storehouse.
In above-mentioned arbitrary scheme, preferably, described break storehouse comprises the break database of the medicine break standard making of recommending according to CLSI.
The system of a kind of Bacteria Identification and Analysis of Drug Susceptibility, comprise Bacteria Identification system and Analysis of Drug Susceptibility system, comprise kit, kit pallet, is characterized in that, described Bacteria Identification system is for being placed in described kit by bacterium, observe Bacteria Identification reagent in described bacterium and described kit and produce reacted color, and be converted to numeral, and described numeral is encoded, according to described numerical coding, from bacterial identification storehouse, obtain described bacteria name; Described Analysis of Drug Susceptibility system is for being placed in described kit by target bacteria, after described target bacteria and susceptibility analytical reagent in described kit produce and react, and the optical density of the bacterium liquid that mensuration obtains, and then analyze the susceptibility of susceptibility.
Preferably, the described numeral that converts to comprises according to the reacted color of described generation and judges response situation, then converts numeral to according to described response situation.
In above-mentioned arbitrary scheme, preferably, describedly according to described response situation, convert numeral to and comprise according to described response situation and encoding, described response situation is positive is 1, and feminine gender is 0.
In above-mentioned arbitrary scheme, preferably, described coding comprises that three one are combined into a numeral, and then form final 5 or 6 codings according to the cryptoprinciple of BCD coding.
In above-mentioned arbitrary scheme, preferably, when described response situation is intermediary, both carry out the described coding as 1, also carried out the described coding as 0.
In above-mentioned arbitrary scheme, preferably, described bacterial identification storehouse refers to the database of producing according to the response characteristic in the biochemical hole in described kit.
In above-mentioned arbitrary scheme preferably, described in analyze susceptibility susceptibility comprise the concentration that calculates described bacterium liquid according to described optical density, then according to drug sensitivity described in described concentration and the comparative analysis of break storehouse.
In above-mentioned arbitrary scheme, preferably, described break storehouse comprises the break database of the medicine break standard making of recommending according to CLSI.
With prior art, compare, the present invention has following benefit:
1,, for medical microbial check work provides an automatic bacteria evaluation/drug sensitive experiment system, make Bacteria Identification/drug sensitive test accuracy, summary, traceization, rapid more.
2, Bacteria Identification is originally the technical work of a system, complexity, and the use of instrument has replaced loaded down with trivial details manual operations to a great extent, has improved work efficiency, from manual to robotization; According to the reactiveness of biochemical, adopt bacterial identification method, can automatically identify bacterium result.
3, according to the reactiveness of susceptibility, adopt existing Antimicrobial Susceptibility Testing Methodologies, the medicine break value that in more default microbiotic storehouse, antibiotic concentration value and CLSI recommend, and then analyze susceptibility-resistance, sensitivity or the intermediary of susceptibility, can avoid the error of artificial judgment.
Embodiment
In order to understand better the present invention, below in conjunction with accompanying drawing, introduce in detail several according to the specific embodiment of the method and system of a kind of Bacteria Identification of the present invention and Analysis of Drug Susceptibility.
(1) Bacteria Identification: shown in legend 1
Step 1: manually measurable kit is placed in the kit pallet of Bacteria Identification Analysis of Drug Susceptibility instrument equipment;
Step 2: judge whether automatic interpretation kit: when result is yes, enter step 3; Otherwise enter step 4;
Step 5: obtain automatic interpretation order, kit pallet enters the interpretation region of Bacteria Identification Analysis of Drug Susceptibility instrument equipment together with kit;
Step 6: judge whether kit pallet arrives surveyed area: when result is yes, enter step 7; Otherwise enter step 8;
Step 9: the color of obtaining reagent cup in kit;
Step 10: the color that judges reagent cup in kit: negative when result, enter step 11; Positive when result, enter step 12; When result is intermediary, enter step 13;
Step 14: each state is converted to numeral: positive is converted to numeral " 1 "; Negative status is converted to digital " 0 "; Intermediate state is converted to digital " 0 " and " 1 " simultaneously;
Step 15: according to BCD coding, the numeral in three biochemical cups is one to be combined into one-bit digital, finally forms 5 or 6 codings (intermediary participates in the calculating of feminine gender/positive simultaneously)
Step 16: according to coding, obtain target bacteria title in bacterial identification storehouse
Step 17: finish
(2) susceptibility is identified: shown in legend 2
Step 18: manually measurable kit is placed in the kit pallet of Bacteria Identification Analysis of Drug Susceptibility instrument equipment;
Step 19: judge whether automatic interpretation kit: when result is yes, enter step 20; Otherwise enter step 21;
Step 22: obtain automatic interpretation order, kit pallet enters the interpretation region of Bacteria Identification Analysis of Drug Susceptibility instrument equipment together with kit;
Step 23: judge whether kit pallet arrives surveyed area: when result is yes, enter step 24; Otherwise enter step 25;
Step 26: the turbidity value that obtains each reagent cup in kit;
Step 27: according to turbidity threshold library (this storehouse is that the empirical data of obtaining after great many of experiments forms), judge the turbidity state of reagent cup: when result is clear, enter step 28; When result is muddy, enter step 29;
Step 30: the actual measurement MIC value of obtaining antibiotic last clear hole;
Step 31: relatively survey MIC value and medicine break value: when the default S value of actual measurement MIC value <=, enter step 32,35; When actual measurement MIC value=default I value, enter step 33,36; When the default R value of actual measurement MIC value >=, enter step 34,37;
Step 38: record the final susceptibility of microbiotic
Step 39: finish
(3) be illustrated in figure 3 according to a specific embodiment of the method and system of a kind of Bacteria Identification of the present invention and Analysis of Drug Susceptibility, dispose casing, kit, reagent.Casing is used for analyzing relatively, and kit is placed in kit pallet, and kit is used for being installed reagents.
Wherein, described Bacteria Identification system is for being placed in described kit by bacterium, observe Bacteria Identification reagent in described bacterium and described kit and produce reacted color, and be converted to numeral, described numeral is encoded, according to described numerical coding, from bacterial identification storehouse, obtain described bacteria name; Described Analysis of Drug Susceptibility system is for being placed in described kit by target bacteria, after described target bacteria and susceptibility analytical reagent in described kit produce and react, and the optical density of the bacterium liquid that mensuration obtains, and then analyze the susceptibility of susceptibility.The described numeral that converts to comprises according to the reacted color of described generation and judges response situation, then converts numeral to according to described response situation.Describedly according to described response situation, convert numeral to and comprise according to described response situation and encoding, described response situation is positive is 1, and feminine gender is 0.Described coding comprises that three one are combined into a numeral, and then form final 5 or 6 codings according to the cryptoprinciple of BCD coding.During described intermediary situation, both carried out the described coding as 1, also carried out as described in 0.Described bacterial identification storehouse refers to the database of producing according to the Antibiotics in various described agent plate.The described susceptibility that analyzes susceptibility comprises the concentration that calculates described bacterium liquid according to described optical density, then according to drug sensitivity described in described concentration and the comparative analysis of break storehouse.Described break storehouse comprises the break database of the medicine break standard making of recommending according to CLSI.
Binary-coded decimal (Binary-Coded Decimal) also claim BCD or binary-decimal code.Represent these 10 numbers of 0 ~ 9 in 1 decimal number with 4 bits.Be a kind of binary numerical coding form, use binary-coded decimal code (BCD code).This coding form of binary-coded decimal has utilized four bits to store a metric number, and the conversion between scale-of-two and the decimal system is carried out efficiently.This coding skill is most commonly used in the design of accounting system, because accounting system often need to be done to calculate accurately to very long numeric string.With respect to general floating point type number scale, adopt binary-coded decimal, the degree of accuracy that both can preserve numerical value, spent time in the time of can exempting from again but to make computer make floating-point operation.In addition, the calculating that needs pinpoint accuracy for other, BCD coding is also in daily use.
CLSI is the english abbreviation of the U.S. [Association for Standardization of clinical labororatory], English Clinical and Laboratory Standards Institute by name.
CLSI predecessor is NCCLS[National Committee of Clinical Laboratory Standards], English name is National committee for clinical laboratory.
Antimicrobial agents sensitivity tests method of operating and the criterion of U.S. CLSI are that domestic clinical bacteria is checked the standard of following.Owing to working out this standard, need to drop into a large amount of manpowers, financial resources and material resources, so most countries comprises China, all also do not have ability to set up the standard of oneself and rely on method and the standard of CLSI.CLSI standard is upgraded every year!
Part of standards and the guide of CLSI are as follows:
1. AST2-A, other (Point-of-Care) in-vitro diagnosis of bed (IVD) detects: approval guide (1999).
Presents is that the user of in-vitro diagnosis (IVD) equipment beyond clinical labororatory provides the guide that produces reliable results.
2. C12-A, vim and vigour and pH analyze relevant amount and the definition of conversion: approval standards (1994).
C12-A discusses specific term and provides vim and vigour and the statistical interpretation of pH analytical calculation (referring to relevant publication C25-A and C27-A).
3. C21-A, the performance characteristic of measurement blood sample pO2 and pCO2 equipment: approval standards (1992).
By American National Standards Institute (ANSI), ratified.C21-A has inquired into performance and the methodology (referring to relevant publication C27-A) for CO2 and O2 partial pressure design an apparatus in measurement blood.
4. C24-A2, quantitative measurement statistical quality control: principle and definition: approval guide (1999).This guide provides the definition of analystal section; The guide of the plan of method of quality control and quality control application.
5. C27-A, Consideration before blood gas analysis: specimen collection, calibration and control: approval guide (1993).By American National Standards Institute (ANSI), ratified.The guide that C27-A provides the blood specimen of artery to collect and process for pH and blood gas analysis; The calibration of blood gas analysis instrument and the suggestion (referring to relevant publication C12-A, C21-A, H11-A2 and M29-A) that comprises acceptable Quality Control Procedure are discussed.
6. C28-A2, the reference interval of how to confirm clinical examination: approval guide (2000).Presents is to determine the reference value of quantitative clinical Interventions Requested and the guide of reference interval.
7. C29-A2, the standardization of the electrode system that sodium potassium ion is selected: approval standards (2000).This standard comprises son suggestion by ion-selective electrode measurement sodium, potassium ion activity results expression in undiluted serum, blood plasma or whole blood.
8. C30-A, the detection of (bed is other) blood glucose is assisted by acute and chronic disease health institution: approval guide (1994).Presents provides an other blood glucose to detect the guide of performance.This file has been emphasized quality control, training and administration function.
9. C31-A, ionized calcium is measured: variation before sampling, sample selection, sampling and processing: approval guide (1995).Presents discussion affects the front Consideration of analysis of ionized calcium accuracy of measurement and clinical utilization, as patient status, sample are selected, sample and process.
10. C32-P, in whole blood, vim and vigour, electrolyte and analyte of interest are measured Consideration simultaneously: recommend guide (1993).Presents has been described at whole blood and has been measured the factor of considering before vim and vigour, electrolyte (sodium, potassium and ionized calcium) and analyte of interest (glucose) are analyzed simultaneously, and processed conventionally suggestion is provided.
11. C34-A2, the detection of sweat: sample collection and quantitative test, approval guide (2000).This guide is described the quantitative test of chlorine, sodium in sweat stimulation, collection and sweat, emphasizes to avoid volatilization simultaneously and pollutes.The quality control of sweat detection and possible source of error have been discussed.
12. DI1-A2, the term of immune diagnostic method, reagent and reference substance and guide: approval guide (19992).The user that this guide is immunodiagnosis system and producer provide general term and basic methodology (referring to relevant publication LA1-A2).
13. DI2-A2, immunoprecipitation analysis: the program of evaluating material performance, approval guide (1999).This guide provides program and the relevant specific discussion of evaluating immunoprecipitation analysis material property.
14. DI3-A, aggegation analysis: antibody feature, methodology, limitation and clinical meaning, approval guide (1993).This guide is described feature and the limitation of agglutination technology antigen and antibody specific, label information and aggegation method.
15. DI4-T, enzyme and fluoroimmunoassay: test, property guide (1986).This guide discussion affects the factor of reliable and reproducible results.It describes how to select enzyme fluorescing system; How to process, purifying and antibody and antigenic characteristic; Reagent isolation technics; Instrument and equipment.
16. EP5-A, the evaluation of the accurate performance of clinical chemistry equipment: approval guide (1999).Presents provides guide for the accurate performance test of design evaluation clinical chemistry instrument; More whether the precision that result is estimated and the precision of manufacturer require to compare, and determine effective.
17. EP6-P, the evaluation of quantitative analysis method linearity: recommend guide (1986).Presents comprises evaluation appts or whether quantitative analysis method meets the linear method requiring of manufacturer; And for providing, manufacturer detects the guide that the range of linearity is stated.
18. EP7-P, clinical chemistry interference test, recommends guide (1986).This guide provides information and the program of description disturbance material on test findings impact.
19. EP9-A, are used patient's sample to carry out method relatively and bias is estimated: approval guide (1995).Presents has been described the method for determining two clinical methods or instrument bias; And design and the data analysis of patient's sample comparative experiments method are cut apart in use.
20. EP10-A, the preliminary assessment of the quantitative clinical method of inspection: approval guide (1998).This guide is discussed the experimental design and data analysis (referring to producing mutually publication GP10-A) of analytical approach or instrument performance preliminary assessment.
21. EP13-R, laboratory statistic-standard deviation: report (1995).This report provides the correct method that calculates standard deviation.
22. GP5-A, clinical labororatory's waste management: approval guide (1993).Presents provides guide for safe handling and the discharge of chemistry, infectiousness, radioactivity and physics refuse that clinical labororatory produces.
23. GP6-A, the system of inventory control of labware: approval guide (1994).
24. GP9-A, the selection of reference laboratory and evaluation: approval guide (1998).This guide has been summarized reason and the criterion of selecting reference laboratory.The checklist in evaluation reference laboratory is helpful to decision process.
25. GP10-A, are used ROC curve to evaluate the accuracy of clinical testing: approval guide (1995).Presents has been described the research and design of clinical testing accuracy estimating: the method for making ROC curve; Vocabulary of terms; And computer software (referring to relevant publication EP 10-A).
26. GP11-A, clinical labororatory's cost accounting: approval guide (1998).Presents provide laboratory room managing person set up can running cost accounting system principle and Fang Zhi.
27. GP14-A, the mark of family expenses in-vitro diagnosis articles for use: approval guide (1996).
28. GP16-A, collection, transportation and the preservation of conventional analysis and urine sample: approval guide (1995).This guide is described routine urinalysis test process, and it comprises material and facility, visual check, clinical analysis, microscopic evaluation.It provides specimen collection, can accept the information such as sample standard and preservation condition.
29.GP17-A, the safety of clinical labororatory: approval guide (1996).American National Standard.Presents is containing the general guideline of carrying out high-quality laboratory safety program.This frame tube is closed the laboratory in any other.
30.GP18-A, lab design: approval guide (1998).This guide provides the Information base about lab design factor.These factors can be used to help Design Laboratory.
31.GP19-A, Laboratory Instruments and data management system: the confirmation of software users Interface design and end user terminal software systems, operation and supervision; Approval guide (1995).
32.GP21-A, the approval of the training of lab assistant: approval guide (1995).
33.H2-A3, erythrocyte sedimentation test (ESR) method-third edition: approval standards (1993).American National Standard.This standard to describe reference and standardization erythrocyte sedimentation rate side ratio juris, materials and methods.This file also provides the Quality Control Procedure of evaluating conventional method program and sedimentation test.
34.H3-A4, venesecton is taked the method-tetra-editions of blood specimen: approval standards (1998).The method that presents provides venesecton to take blood sample, and object is increasing analyte integrality and the training program (referring to relevant publication H18-A2 and M29-A) that reduces experimental error.
35.H4-A4, percutaneous puncture is taked the method-tetra-editions of blood specimen: approval standards (1999).This standard provides appropriate blood collecting technology and due to incorrect use skin penetrating make a collection of specimens detailed description and the explanation (referring to relevant publication H18-A2, LA4-A3 and M29-A) of the harm to patient.
36.H5-A3, the diagnosis transportation of sample and the process of processing: approval standards (1994).
37.H9-A, chromatography (microtrabeculae) Measuring hemoglobin A: approval standards (1989).American National Standard.The selection of conventional HbA2 method for quantitatively determining has been described.
38.H11-A3, program-second edition that ABS gathers: approval standards (1992).
39. H142A2, equipment 2 second editions of percutaneous puncture blood sample collection: approval guide (1990).
40. H152A2, the reference of quantitative measurement haemoglobin and system of selection 2 second editions: approval standards (1994).
41. H172A, the mensuration of serum levels of iron and total iron binding capacity: approval standards (1998).
42. H182A2, blood specimen disposal route: approval guide (1999).
43. I22A2, temperature correction 2 second editions of water bath, instrument and temperature sensor: approval standards (1990).
44. I172P, the protection instrument harm of laboratory worker: recommend guide (1991).
45.L42A3, collection 2 third editions of neonatal screening plan filter paper blood sample: approval standards (1992).
46. ILA92T, Serum Digoxin candidate reference method: radio-immunity reference method; Tentative guide (1996).
47. EP112P, in-vitro diagnosis test coherence request: recommend guide (1996).
48. GP22A3, procedure manual 2 third editions of clinical laboratory technology: approval guide (1996).
49. H12A4, the vacuum tube that blood specimen is collected and adjuvant 2 the 4th edition: approval standards (1996).
50. H262A, the performance objective of the indoor control of hyperchannel blood analyser: approval standards (1996).
51.AST42A, is not having blood glucose under laboratory support condition to detect: approval guide (1999).This guide detects blood glucose personnel for the place beyond traditional clinical labororatory suggestion is provided.This guide has also been described the responsibility of experimental performance, quality control, staff training and management.
52. GP222A, lasting quality improvement, management method basis: approval guide (1999).
53. ILA152A, the performance characteristic of apolipoprotein immune detection, exploitation and recommendation: approval guide (1997).
54. TDM62A, clinical labororatory's blood alcohol detection: approval guide (1997).
55. C382A, the control that determination of trace element makes a variation before analyzing: approval guide (1997).
56. C32A3, preparation and the test of clinical labororatory's reagent water: approval guide (1997).
T>MIC (or Time>MIC): refer to the time of drug concentration higher than MIC. MIC: minimum inhibition concentration, represent antibiotic antibacterial activity, refer to suppress the minimum antibacterial concentration of bacteria growing.This medicine of the lower explanation of MIC is stronger to the effect of corresponding pathogen.Popular point is said and is exactly: the least concentration that can suppress bacterial growth in nutrient culture media.