MICROPRO AST - Performance Evaluations ISO 13485:2016 - Tulip Diagnostics
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ISO 13485:2016
Performance Evaluations
MICROPRO AST
Antimicrobial Susceptibility Testing SystemPerformance Evaluations ISO 13485:2016
INDEX
S.No. Name of the Publications Pg. Nos.
TM
1 Comparison of Micropro MIC system against Vitek 2 compact system 110
MICROPRO AST
Antimicrobial Susceptibility Testing SystemPerformance Evaluations ISO 13485:2016
External Evaluations
INDEX
S.No. Topic Evaluated by
1 Evaluation of Micropro AST with the conventional Kirby Bauer Method Goa Medical
for Rapid Antimicrobial Susceptibility testing College & Hospital,
Bambolim, Goa
2 Evaluation of Micropro AST with the BD Phoenix for Rapid Antimicrobial Infexn Labs. Pvt.
Susceptibility testing for all sample types Ltd., Thane,
Mumbai
MICROPRO AST
Antimicrobial Susceptibility Testing System110 Antimicrobial resistance / International Journal of Infectious Diseases 101(S1) (2021) 8–119
0263 0264
Comparison of MicroproTM MIC system against Save Carbapenem Campaign: Laboratory
Vitek 2 compact system assessment of carbapenem devoid antibiotic
combinations against multidrug resistant gram
A.K. Bari 1,∗ , A. Poojary 2 , P. Divekar 3 , L. Gurav 4 , J.
negative bacilli
Pereira 5 , R. Kokare 5 , S. Rohra 2
1
R. Tellis
Breach Candy Hospital Trust, Pathology and
Microbiology, Mumbai, Maharashtra, India Yenepoya University, Microbiology, Mangalore, India
2 Breach Candy Hospital Trust, Microbiology,
Background: Infections caused by MDR gram negative bacilli
Mumbai, India
3 Breach Candy Hospital Trust, Pathology and (MDR-GNB) are a therapeutic challenge to clinicians and Combina-
tion antimicrobial therapy with empirically selected antibiotics is
Microbiology, Mumbai, India
4 Breach Candy Hospital Trust, Department of often used to treat these infections. This approach is poorly guided,
as the antibiotics selected may not be optimal because of different
Pathology and Microbiology, Mumbai, India
5 Breach Candy Hospital Trust, Dept of Pathology & killing activity. This study aims to determine in-vitro efficacy of
antibiotic combinations devoid of carbapenems to explore poten-
Microbiology, Mumbai, India
tial synergy between antibiotics of different chemical classes.
Background: Antimicrobial susceptibility testing (AST) is the Methods and materials: Prospective, experimental descriptive
cornerstone for managing bacterial infections but is a costly affair study of 85 MDR-GNB isolated from clinical samples. MIC of cef-
in most developing nations. Absence of AST data is known to lead to tazidime, amikacin, imepenem and ciprofloxacin was determined
irrational use of antibiotics paving the way for antimicrobial resis- by broth micro-dilution. Invitro effect of CAZ-AMK, CAZ-CIPRO,
tance amongst bacteria. The VITEK 2 compact (V2C) (bioMérieux) IMP-AMK & IMP-CIPRO combinations studied by checker-board
is a popular yet expensive choice for automated AST in develop- assay.
ing nations. In order to optimize the use of anti-microbial agents Results: ESBL, AmpC & MBL production was seen among 62.35%,
the availability of a cost-effective, robust, reliable, and accurate 27.05% & 44.70% of the MDR-GNB respectively.
AST system comparable to other well-established AST systems like 27.05% co-produced multiple -lactamases.
Vitek is the need of the hour. MIC90 ranges for CAZ: 16–≥1028 g/ml, Amk: 0.25–≥
Methods and materials: 600 non-duplicating pathogenic iso- 256 g/ml, CIPRO: 0.25–12 g/ml and IMP: 0.125–512 g/ml.
lates Klebsiella pneumoniae (n = 101), Escherichia coli (n = 96), CAZ-AMK and IMP-AMK combinations showed synergistic
Salmonella spp. (n = 42), Pseudomonas aeruginosa (n = 100), Acine- effect in >85% of MDR-GNB with FICI ≤0.5.
tobacter baumanii (n = 71), Staphylococcus aureus (n = 93) and Higher rates of indifference & antagonism observed with com-
Enterococcus spp. (n = 97) were included in the study. The panels binations having fluroquinolones.
used for MicroproTM was GP1, GN1 and GN3 while P628, N280 Conclusion: In-vitro antimicrobial activity of antibiotic com-
and N281 cards were used for V2C. Both the systems are princi- binations having 3rd or 4th generation cephalosporin with
pally based on BMD assays. AST was performed in accordance with aminoglycosides was comparable to that of imepenem mono or
the manufacturers’ guidelines. Interpretation’s were done as per combination therapy.
Clinical & Laboratory Standards Institute (CLSI) guidelines (2018). Combinations devoid of carbepenems to be advocated to pro-
Escherichia coli ATCC 25922, Pseudomonas aeruginosa ATCC 27853 long the clinical usefulness of this antibiotic group.
and Staphylococcus aureus ATCC 29213 were the quality control
strains tested. https://doi.org/10.1016/j.ijid.2020.09.307
Results: The Categorical and Essential Agreements (CA and EA)
for Klebsiella pneumoniae, Escherichia coli, Salmonella spp., Pseu- 0265
domonas aeruginosa, Acinetobacter baumanii, Staphylococcus aureus
The determinants of presumptive antibiotic
and Enterococcus spp. were within the acceptable limits (≥90%) as
prescribing behavior among early career
per CLSI guidlines for Verification of commercial microbial identifi-
physicians in Delhi, India
cation and antimicrobial susceptibility testing systems. The Major
errors (ME) and Minor errors (MinE) for Klebsiella pneumoniae, S. Basu 1,∗ , N. Bhatnagar 2
Escherichia coli, Salmonella spp., Pseudomonas aeruginosa, Acineto- 1 Maulana Azad Medical College, Community
bacter baumanii, Staphylococcus aureus and Enterococcus spp. were
Medicine, New Delhi, India
reported to be 1.4%, 7.6%, 4%, 1.6%, 3.1%, 6.6%, 3.2% and 5%, 4.4%, 2 Army College of Medical Sciences, Community
4.9%, 5%, 3.8%, 4%, 2.8% respectively. The cost per reportable test
Medicine, New Delhi, India
(CPRT) for MicroproTM (2.82$) is approximately half of V2C (4.87$),
whereas the capital investment for MicroproTM is 7041$–8453$ and Background: Over-prescription of antibiotics by physicians is
for V2C is 20429$–23247$. a major cause of increasing antimicrobial resistance globally. We
Conclusion: The results reported by the cost-effective, robust, conducted this study to identify the factors that influence pre-
reliable, and accurate MicroproTM AST system are comparable with sumptive antibiotic prescribing behaviors of early career physicians
the well-established automated VITEK 2 Compact system. during outpatient care in Delhi, India.
Methods and materials: We conducted a cross-sectional study
https://doi.org/10.1016/j.ijid.2020.09.306 among 125 prescribers affiliated to a premier medical college
in New Delhi, India. The study sample comprised of 60 first
and second year postgraduate resident doctors from clinical
departments, and 65 medical interns who had completed at-
least eight months of their stipulated one year of internship. We
collected data from the participants during September-October’
2019 after ethical approval. Data was collected using a self-Performance Evaluations ISO 13485:2016
EXTERNAL EVALUATIONS
MICROPRO AST
Antimicrobial Susceptibility Testing SystemTM TM
Evaluation of Micropro ~ AST with BD Phoenix
for Rapid Antimicrobial Susceptibility Testing of all Sample Types
Objective:
TM
To assess the performance of Micropro ~ AST for rapid Antimicrobial Susceptibility testing.
TM TM
To compare the performance of Micropro ~ AST by comparing the results with BD Phoenix .
To derive “Correlation Percentage” which describes the percentage similarity or correlation of
TM TM
Micropro ~ AST results with BD Phoenix .
TM
To assess the performance of individual antibiotics by comparing the results of Micropro ~ AST and BD
TM
Phoenix
Study Methods:
50 samples were used for the evaluation performed under the supervision of Dr. Sonal Bangade at Infexn
Laboratories Pvt Ltd.
TM
The Micropro ~ AST reagents bearing Lot No. P150218, N150218, U200218 were used in the evaluation
TM
and the performance was compared with the results of BD Phoenix .
Results:
Sample wise AST Report Analysis
Panels Percentage Correlation
Gram Negative Pathogens 92
Gram Positive Pathogens 90
UTI Pathogens 95
Overall 92
Antibiotic wise AST Report Analysis
When comparing individual antibiotic performance, an agreement of 84 – 100% has been observed between
TM TM
Micropro ~ AST and BD Phoenix .
Conclusion:
TM TM
After comparing the percentage similarity of Micropro ~ AST results with BD Phoenix , an overall correlation
percentage of 92.3 % was observed.
Antibiotic wise AST report analysis showed an overall correlation percentage of 92 %.
1Background:
The primary role of clinical microbiology laboratory personnel is to provide the information with which physicians
can diagnose and treat the infectious diseases. If a communicable disease is present, the identification of a
specific pathogen is of utmost importance to a hospital epidemiologist or public healthcare worker.
However, the two most important pieces of information for a clinician are;
1) Whether an infectious agent is present, and
2) Which antimicrobial agent should provide adequate therapy?
The most widely used conventional method for antibiotic susceptibility testing includes the disk diffusion method
which takes about 12 to 16 hours. The later generation testing methods include Broth Microdilution method and
are associated with instruments. Use of instrumentation can standardize the reading of end points and often
produce susceptibility test results in a shorter time period. Sensitive optical detection systems allow detection of
TM
the even subtle changes in bacterial growth. Micropro ~ AST is a system intended for Antimicrobial
Susceptibility Testing of most pathogens involved in various samples of UTI, GI, GT, ENT, CNS, Blood etc. within
5-8 hours.
Study Method:
1. Patient samples received were inoculated on plates and incubated overnight.
2. Culture plates with positive results were received and registered with unique Sample ID and Tray ID.
3. A total of 50 positive samples from various clinical sources were tested for this evaluation.
4. Culture suspension with McFarland standard 0.5 was prepared from each culture.
TM
5. For detailed SOP refer Micropro ~ AST packinsert attached.
6. Results obtained from both the methods were noted down and compared.
7. All the results were tabulated together and “Correlation Percentage” is calculated.
Samples used for evaluation:
Urine, Sputum, Pus, CVP TIP, ET TIP, CSF
TM
Micropro ~ AST Kit – Lot No: P150218, N150218, U200218.
Procedure:
TM TM
The test procedure, as mentioned in the packinsert of Micropro ~ AST and BD Phoenix .
Observations and Results:
Sample wise AST Report Analysis for Gram Negative Pathogens
Sample ID Pathogen Total Antibiotics Tally Correlation percentage
72012496 Escherichia coli 24 22 92
72030208 Escherichia coli 24 24 100
72030364 Escherichia coli 24 17 71
71974835 Escherichia coli 20 19 95
72031282 Escherichia coli 24 19 79
72006709 Escherichia coli 24 24 100
72031053 Escherichia coli 24 20 83
72030208 Escherichia coli 24 24 100
72026451 Escherichia coli 24 21 88
72031283 Pseudomonas aeruginosa 21 19 90
72031078 Pseudomonas aeruginosa 21 19 90
72030839 Pseudomonas aeruginosa 21 20 95
71980195 Klebsiella pneumoniae 23 21 91
72031052 Klebsiella pneumoniae 23 22 96
71979306 Acinetobacter baumannii 23 21 91
272019882 Acinetobacter baumannii 23 23 100
72030923 Proteus mirabilis 18 16 89
72031281 Morganella morganii 23 23 100
72031037 Burkholderia cepacia 19 17 90
Cumulative Correlation % 92
AST Report Analysis for Gram Positive Pathogens
Sample ID Pathogen Total Antibiotics Tally Correlation percentage
72031621 Enterococcus faecalis 11 10 91
72031620 Enterococcus faecalis 11 9 82
72023423 Enterococcus faecalis 11 9 82
58544657 Enterococcus faecalis 11 9 82
72019804 Staphylococcus aureus 18 16 89
72031447 Staphylococcus aureus 16 15 94
72031456 Staphylococcus aureus 18 18 100
Cumulative Correlation % 90
AST Report Analysis for UTI Pathogens
Sample ID Pathogen Total Antibiotics Tally Correlation percentage
78769948 Escherichia coli 20 19 95
72026126 Escherichia coli 20 19 95
71980608 Escherichia coli 20 19 95
72019654 Escherichia coli 20 20 100
71977313 Escherichia coli 20 19 95
84415736 Escherichia coli 20 19 95
60131693 Escherichia coli 20 20 100
96528887 Escherichia coli 20 20 100
72026221 Escherichia coli 20 20 100
72019502 Escherichia coli 20 20 100
72030782 Escherichia coli 20 20 100
72030800 Escherichia coli 20 20 100
72030777 Escherichia coli 20 20 100
70030776 Escherichia coli 20 20 100
72030771 Escherichia coli 20 20 100
69181321 Escherichia coli 20 18 90
84035012 Escherichia coli 20 20 100
72030922 Escherichia coli 20 17 85
72026330 Escherichia coli 20 17 85
72026466 Escherichia coli 20 13 65
Cumulative Correlation % 95
3Antibiotic wise AST Report Analysis
Antibiotics Total Cases Tally Percentage
Ampicillin 45 40 89
Tobramycin 43 41 95
Ciprofloxacin 49 46 94
Gentamicin 44 35 80
Nitrofurantoin 49 46 94
Norfloxacin 45 44 98
Trimethoprim/Sulfamethoxazole 43 39 90
Ceftriaxone 43 39 90
Amoxicillin/Clavulanic acid 49 48 98
Chloramphenicol 28 26 93
Doxycycline 24 16 67
Amikacin 40 36 90
Levofloxacin 39 38 97
Tetracycline 35 30 86
Cefazolin 40 39 98
Cefepime 40 39 98
Ceftazidime 40 39 98
Aztreonam 40 39 98
Meropenem 39 36 92
Piperacillin/Tazobactam 39 38 98
Ampicillin/Sulbactam 35 31 89
Cefoxitin 19 19 100
Imipenem 18 15 84
Penicillin 9 7 78
Teicoplanin 9 9 100
Erythromycin 9 7 78
Clindamycin 4 3 75
Oxacillin 4 2 50
Linezolid 9 8 89
Vancomycin 9 9 100
Moxifloxacin 4 3 75
Rifampin 3 3 100
Azithromycin 3 3 100
Fosfomycin 21 21 100
Total Cases 970 894 92
4Results:
Sample wise AST Report Analysis
Panels Percentage correlation
Gram Negative Pathogens 92
Gram Positive Pathogens 90
UTI Pathogens 95
Overall 92
Antibiotic wise AST Report Analysis
When comparing individual antibiotic performance, an agreement of 84 – 100% has been observed between
TM TM
Micropro ~ AST and BD Phoenix .
Discussion:
Sample wise AST Report Analysis for Gram Negative Pathogens
TM
Antibiotics panels were run of both MicroproTM ~ AST and BD Phoenix and reports were collected for further
analysis. Both manufacturers have different sets of antibiotics for Gram negative, Gram positive and UTI panels.
Against one patient ID, the results of antibiotics common in both the panels (for MicroproTM ~ AST and BD
TM
Phoenix ) were compared and a tally score was obtained and correlation percentage was calculated.
The results obtained were tabulated for each patient ID for the three panels GN, GP and UTI.
The overall correlation percentage obtained was 92.3 %.
Antibiotic wise AST Report Analysis
Out of the common antibiotics compared in both the systems, individual antibiotic performance was also
assessed.
Total number of cases was noted against each antibiotic, and the tally score was obtained based on the number
of cases the results are in agreement. The results obtained were tabulated for each antibiotic for all the 50
TM TM
cases. An agreement of 84 – 100% has been observed between Micropro ~ AST and BD Phoenix .
Less than 80 % score was also obtained for few antibiotics, which may be due to insufficient sample size.
Conclusion:
TM
With Micropro ~ AST system, susceptibility test results can be delivered rapidly.
TM
Micropro ~ AST system and computerized user interface are convenient to work with.
Sample preparation and result interpretation requires less effort and expertise.
TM
With a cumulative Correlation Percentage of 92 %, Micropro ~ AST system is an ideal tool for routine
susceptibility testing in microbiology laboratories.
5TULIP DIAGNOSTICS (P) LTD
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