Evaluation for Different Models of the Automated Mass

Spectrometry Microbial Identification System

Autof ms1000 / Autof ms2000 / Autof ms600 / Autof ms800 / Autof

ms1600 / Autof ms2600

(Autofms11011021, Autofms11021021, Autofms11031021, Autofms11041021,

Autofms11051021, Autofms11061021)

Author(s) Approver

Name: Liu Meili Name: Zhao Gaoling

Function/Department: RA Manager Function/Department: QA Manager

Signature:/Signed/ Signature: /Signed/

Date: 2022.9.3 Date: 2022.9.3

 Table of Contents
1. Purpose.........................................................................................................................................1
2. Materials for performance evaluation..........................................................................................1
2.1Evaluated Instruments.......................................................................................................1
2.2Evaluated strains...............................................................................................................1
3. Protocol........................................................................................................................................1
3.1Evaluation environment....................................................................................................1
3.2Performance parameter.....................................................................................................2
3.2.1 Sensitivity..........................................................................................................2
3.2.2 Mass resolution.................................................................................................2
3.2.3 Mass accuracy...................................................................................................2
3.2.4 Mass repeatability.............................................................................................3
3.2.5 Mass stability.....................................................................................................4
3.2.6 Identification accuracy......................................................................................4
3.3Safety evaluation...............................................................................................................4
3.3.1. Grounding impedance test................................................................................4
3.3.2. Dielectric strength test......................................................................................5
3.3.3. Contract current test.........................................................................................5
4. Results..........................................................................................................................................5
4.1Performance parameter.....................................................................................................5
4.1.1. Sensitivity.........................................................................................................5
4.1.2. Mass resolution................................................................................................5
4.1.3. Mass accuracy..................................................................................................7
4.1.4. Mass repeatability............................................................................................8
4.1.5. Mass stability....................................................................................................8
4.1.6. Identification accuracy.....................................................................................9
4.2Grounding impedance test...............................................................................................11
4.3Dielectric strength test.....................................................................................................11
4.4Contract current test........................................................................................................11
5. Conclusion..................................................................................................................................12
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1. Purpose

The purpose of this study is to various performance characteristics of the 6 models of Automated
Mass Spectrometry Microbial Identification System.

2. Materials for performance evaluation

2.1 Evaluated Instruments

The 6 models of Automated Mass Spectrometry Microbial Identification System used in this
study were listed in table 1.
Table 2 Evaluated instruments

Instrument Modules Instrument No.

Autof ms 600 1103 100 1030
Autof ms 800 1104 100 1022
Autof ms 1000 1101 100 1325
Autof ms 1600 1105 100 1000
Autof ms 2000 1102 100 1024
Autof ms 2600 1106 100 1000

2.2 Evaluated strains

Table 3 Evaluated strains

No. Strain name

1 Enterococcus faecalis (ATCC51299)
2 Escherichia coli (ATCC25922)
3 Enterococcus faecium (ATCC19434)
4 Staphylococcus aureus (ATCC29213)
5 Bacteroides fragilis (ATCC25285)
6 Pseudomonas aeruginosa (ATCC 27853)
7 Candida parapsilosis (ATCC 22019)

3. Protocol

3.1 Evaluation environment

The requirement of the evaluation environment is as follows:

1) Temperature：10℃～30℃；
2) Humidity：Rh≤70%；
3) Atmospheric pressure：700hPa～1060hPa；
4) Power supply： AC 220V±22V，50Hz±1Hz

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3.2 Performance parameter

3.2.1 Sensitivity

Study Description: Inoculate BSA to the target plate and dry at room temperature, overlay the
sample spot with 1µL HCCA, dry at room temperature. Then identify the sample with MALDI-
TOF MS. The information of BSA is listed in the table.

Name M/Z Concentration

BSA 66430.09 Da 1 pmol/µL

Data analysis: Read the data in the displayed graph peak directly. Acceptance Criteria: The
signal-to-noise ratio (S/N) should be ≥ 10.

3.2.2 Mass resolution

Study Description: Inoculate 1µL angiotensinogen, 1µL cytochrome C and 1µL mix protein to
the target plate separately and dry at room temperature, overlay each sample spot with 1ul
HCCA, dry at room temperature. Then identify the sample with MALDI-TOF MS. The
information of angiotensinogen, cytochrome C and mix protein is listed in the table.

Name M/Z Concentration

Angiotensinogen 1760.01 Da 1 pmol/µL
Cytochrome C 12362.96 Da 10 pmol/µL
Mix protein / Insulin: MYO: Cytochrome C (1 pmol:10 pmol: 10 pmol)

Data analysis: Select the method of Peptide-3k and method of Microbe as the calibration method
and test method. The laser is used for 40 times, and each sample is measured for more than 3
effective tests. The resolution of each test and the corresponding instrument parameters were
recorded. Read the data in the displayed graph peak directly.
Acceptance Criteria: The mass resolution of single protein and mixed protein should meet the
following criteria.

Protein name Criteria

Single protein Angiotensinogen Mass resolution ≥3600
Cytochrome C Mass resolution ≥800
Mixed protein Insulin Mass resolution ≥400
Myoglobin M2+ Mass resolution ≥600
Cytochrome C Mass resolution ≥700

3.2.3 Mass accuracy

Study Description: Calibrate the device with the calibrator, acquisit the map of Insulin (m/z=
5808.57(M+H)+) and Cytochrome C (m/z= 12362.96(M+H)+) separately, choose the mass-to-
charge ratio of corresponding mass spectrum peak, then carry out 3 effective tests and calculate
the average value. The information of calibration protein is listed in the table.

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Protein name Concentration Molecular weight

Insulin 1 pmol/ul 5808.57
Cytochrome C 10 pmol/ul 12362.96

Data analysis: Test the Insulin and Cytochrome C after calibration of the device, take 3 maps of
each sample spot. The laser is used for 40 times. Calculate the mass accuracy of each peak in the

map with the formula: ΔM =

|:mtest +mstandart|
× 106
mstandart
ΔM —— Mass accuracy;
mtest ——Average value of test maps from mass-to-charge ratio of corresponding mass spectrum
peak;
mstandart —— Standard value of test maps from mass-to-charge ratio of corresponding mass
spectrum peak.
Acceptance Criteria: Indication error should be less than 100 PPM.

3.2.4 Mass repeatability

Study Description: Calibrate the device with bacterial protein calibrator, acquisit the map of
Insulin and Cytochrome C separately, choose the mass-to-charge ratio of corresponding mass
spectrum peak, then carry out 6 effective tests. The information of calibration protein is listed
in the table.

Protein name M/Z Concentration

Insulin 5808.57 Da 1 pmol/µL
Cytochrome C 12362.96 Da 10 pmol/µL

Data analysis: Test the Insulin and Cytochrome C after calibration of the device, take 6 maps of
each sample spot. The laser was used for 40 times. Calculate the mass repeatability of each peak

√
n
1
in the map with the formula: CV = ∑ ( m −m)2 ×10%
n−1 i=1 i
m

CV —— Mass variation coefficient of the corresponding mass spectrum peak of the map;
mi —— Measured value of the corresponding mass spectrum peak i of the map;
m——average value of 6 measurements of the corresponding mass spectrum peak of the map.
Acceptance Criteria: The CV of peak mass in the chromatograms of insulin and cytochrome C
should be less than 0.02%.

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3.2.5 Mass stability

Study Description: Calibrate the device with bacterial protein calibrator, acquisit the map of
Insulin and Cytochrome C separately, choose the mass-to-charge ratio of corresponding mass
spectrum peak, then carry out 3 effective tests and calculate the average value. Repeat the above
testing process after 24 hours and compare the mass deviation with initial test results. The
information of calibration protein is listed in the table.

Protein name M/Z Concentration

Insulin 5808.57 Da 1 pmol/µL
Cytochrome C 12362.96 Da 10 pmol/µL

Data analysis: Calculate the mass stability of each peak in the map with the formula:
|m2−m1|
D= × 106
m1

D —— Mass stability of mass spectrum peaks;

m1 ——Average value of the 3 measurements of the initial mass spectrum peaks;

m2 ——Average value of the 3 measurements of the initial mass spectrum peaks after 24 hours.
Acceptance Criteria: The relative mass deviation of the test results of peak masses obtained in
the chromatograms of insulin and cytochrome C 24 h after the instrument is turned on and stable
from the initial test result when the instrument is stable should be ≤ 300 ppm.

3.2.6 Identification accuracy

Study Description: Inoculate the 1µL suspension of Enterococcus faecalis (ATCC51299),

Escherichia coli(ATCC25922), Enterococcus faecium(ATCC19434), Staphylococcus
aureus(ATCC21913), Bacteroides fragilis(ATCC25285), Pseudomonas
aeruginosa(ATCC27852), Candida parapsilosis(ATCC22019) to the target plate separately and
dry at room temperature, overlay each sample spot with 1ul HCCA, dry at room temperature.
Then identify the sample with MALDI-TOF MS.
Data analysis: Read the identification value of each sample.
Acceptance Criteria: The identification value should be ≥ 9.0 of standard strains of Enterococcus
faecalis (ATCC51299), Escherichia coli(ATCC25922), Enterococcus faecium(ATCC19434),
Staphylococcus aureus(ATCC21913), Bacteroides fragilis(ATCC25285), Pseudomonas
aeruginosa(ATCC27852), Candida parapsilosis(ATCC22019).

3.3 Safety evaluation

3.3.1. Grounding impedance test

1) Measuring equipment: AC grounding resistance tester

2) Performance indicators: the instrument has no alarm during the test, and the measured
grounding resistance value is less than 100m ω.

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1) Parameter requirements: set grounding resistance tester test parameters: current 10A (AC),
test time 20S, grounding resistance upper limit 0.1 ω;

3.3.2. Dielectric strength test

1) Measuring equipment: AC and DC voltage tester

2) Performance index: no alarm; No breakdown or repeated arcs.
3) Test parameters: a) Basic insulation: test voltage 1390V, voltage rise time 2S, voltage
duration 2s, contact current upper limit 10mA. B) Double insulation: test voltage 2230V,
voltage rise time 2S, voltage duration 2s, contact current upper limit 10mA.

3.3.3. Contract current test

1) Measuring equipment: grounding leakage current tester

2) Performance index:
a) Value under normal conditions: current is not greater than 0.5mA effective value;
b) Limit under single fault condition: current is not greater than 3.5mA effective value.

4. Results

4.1 Performance parameter

4.1.1. Sensitivity

The results of sensitivity on 6 models were as follows:

S/N
Protein Concentr S/N.
Models Laser Repeat Repeat Repeat Final
name ation limit
1 2 3 value
Autof ms600 40 22 20 35 35 >10
Autof ms800 41 17 16 17 17 >10
Autof
40 12 12 13 13 >10
ms1000
1pmol/ Autof
BSA 41 25 28 30 30 >10
µL ms1600
Autof
40 16 15 16 16 >10
ms2000
Autof
41 14 13 19 19 >10
ms2600
Conclusion: According to the above results, the sensitivity of the 6 models met the criteria.

4.1.2. Mass resolution

The results of mass resolution on Autof ms 600 were as follows:

Protein Laser Mass resolution Res. limit
Repeat 1 Repeat 2 Repeat 3 Final value
Angiotensinogen 7 3967 4803 4325 4325 >3600
Cytochrome C 18 1044 1016 924 1044 >800
Mixed protein
21 713 707 756 756 >400
5808.57
Mixed protein
21 1440 1052 1210 1440 >600
8477.14

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Mixed protein
21 879 937 948 948 >700
12362.96

The results of mass resolution on Autof ms 800 were as follows:

Mass resolution
Protein Laser Res. limit
Repeat 1 Repeat 2 Repeat 3 Final value
Angiotensinogen 5 4239 4201 4035 4239 >3600
Cytochrome C 15 853 906 854 906 >800
Mixed
18 1086 784 900 1086 >400
protein5808.57
Mixed protein
18 1284 657 1276 1284 >600
8477.14
Mixed
18 745 781 771 781 >700
protein12362.96

The results of mass resolution on Autof ms 1000 were as follows:

Mass resolution
Protein Laser Res. limit
Repeat 1 Repeat 2 Repeat 3 Final value
Angiotensinogen 5 3727 3798 4492 4492 >3600
Cytochrome C 16 881 915 891 915 >800
Mixed
19 972 934 950 972 >400
protein5808.57
Mixed protein
19 1804 1000 1367 1804 >600
8477.14
Mixed
19 904 785 729 904 >700
protein12362.96

The results of mass resolution on Autof ms 1600 were as follows:

Mass resolution
Protein Laser Res. limit
Repeat 1 Repeat 2 Repeat 3 Final value
Angiotensinogen 7 3714 4429 4000 4429 >3600
Cytochrome C 18 861 990 993 993 >800
Mixed protein
23 699 827 701 827 >400
5808.57
Mixed protein
23 1263 1291 1108 1291 >600
8477.14
Mixed protein
23 827 751 1140 1140 >700
12362.96

The results of mass resolution on Autof ms 2000 were as follows:

Mass resolution
Protein Laser Final Res. limit
Repeat 1 Repeat 2 Repeat 3
value
Angiotensinogen 6 4092 4366 3737 4366 >3600
Cytochrome C 18 985 915 844 985 >800
Mixed protein
21 721 655 693 721 >400
5808.57
Mixed protein
21 1120 806 963 1120 >600
8477.14
Mixed protein
21 811 793 813 813 >700
12362.96

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The results of mass resolution on Autof ms 2600 were as follows:

Mass resolution
Protein Laser Res. limit
Repeat 1 Repeat 2 Repeat 3 Final value
Angiotensinogen 8 3864 5839 4660 5839 >3600
Cytochrome C 20 1036 884 916 1036 >800
Mixed protein
22 525 540 487 540 >400
5808.57
Mixed protein
22 1015 1049 900 1049 >600
8477.14
Mixed protein
22 958 932 909 958 >700
12362.96

Conclusion: According to the above results, the mass resolution of the 6 models met the criteria.

4.1.3. Mass accuracy

The results of mass accuracy on Autof ms 600 were as follows:

Concentratio Molecular Mass accuracy
Protein ppm
n weight Repeat 1 Repeat 2 Repeat 3
Insulin 1 pmol/µL 5808.57 5808.581 5808.758 5808.317 3
Cytochrome
10 pmol/µL 12362.96 12362.647 12362.554 12363.897 6
C

The results of mass accuracy on Autof ms 800 were as follows:

Concentratio Molecular Mass accuracy
Protein ppm
n weight Repeat 1 Repeat 2 Repeat 3
Insulin 1 pmol/µL 5808.57 5808.593 5808.158 5808.821 8
Cytochrome
10 pmol/µL 12362.96 12362.549 12362.105 12363.765 12
C

The results of mass accuracy on Autof ms 1000 were as follows:

Concentratio Molecular Mass accuracy
Protein ppm
n weight Repeat 1 Repeat 2 Repeat 3
Insulin 1 pmol/µL 5808.57 5808.825 5808.376 5808.513 0
Cytochrom
10 pmol/µL 12362.96 12363.277 12362.340 12363.276 0
eC

The results of mass accuracy on Autof ms 1600 were as follows:

Concentratio Molecular Mass accuracy
Protein ppm
n weight Repeat 1 Repeat 2 Repeat 3
Insulin 1 pmol/µL 5808.57 5808.351 5808.923 5808.379 3
Cytochrom
10 pmol/µL 12362.96 12363.491 12363.508 12361.820 2
eC

The results of mass accuracy on Autof ms 2000 were as follows:

Concentratio Molecular Mass accuracy
Protein ppm
n weight Repeat 1 Repeat 2 Repeat 3
Insulin 1 pmol/µL 5808.57 5808.670 5808.623 5808.580 9
Cytochrom
10 pmol/µL 12362.96 12363.067 12363.124 12362.909 6
eC

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The results of mass accuracy on Autof ms 2600 were as follows:

Concentratio Molecular Mass accuracy
Protein ppm
n weight Repeat 1 Repeat 2 Repeat 3
Insulin 1 pmol/µL 5808.57 5808.568 5808.719 5808.431 0
Cytochrom
10 pmol/µL 12362.96 12361.783 12363.032 12362.500 42
eC
Conclusion: According to the above results, the mass accuracy of the 6 models met the criteria.

4.1.4. Mass repeatability

The results of mass repeatability on 6 models were as follows:

Mass repeatability
Protein 1 2 3 4 5 6 CV
Autof
Cytochrome 12362.58
ms 12362.94 12362.871 12362.787 12362.936 12363.185 0.002%
C 3
600
Insulin 5808.325 5808.131 5808.691 5808.905 5808.859 5808.653 0.005%
Autof Cytochrome 12363.80
12362.390 12362.124 12363.076 12363.129 12363.228 0.005%
ms C 7
800 Insulin 5808.850 5808.678 5808.672 5808.397 5808.586 5808.528 0.003%
Autof Cytochrome 12363.169 12363.075 12363.55 12363.600 12362.816 12362.625 0.003%
ms C 1
1000 Insulin 5808.879 5808.621 5808.484 5808.465 5808.646 5808.630 0.003%
Autof Cytochrome 12362.911 12362.039 12363.61 12363.402 12363.638 12362.722 0.005%
ms C 3
1600 Insulin 5808.561 5808.408 5808.978 5809.022 5808.576 5808.321 0.005%
Autof Cytochrome 12363.180 12363.032 12362.59 12363.668 12363.310 12363.772 0.003%
ms C 6
2000 Insulin 5808.627 5808.598 5808.671 5808.688 5808.566 5808.737 0.001%
Autof Cytochrome 12363.481 12361.702 12363.88 12363.471 12362.471 12362.108 0.007%
ms C 4
2600 Insulin 5808.534 5808.759 5808.435 5808.528 5808.826 5808.603 0.003%
Conclusion: According to the above results, the mass repeatability of the 6 models met the
criteria.

4.1.5. Mass stability

The results of mass stability on 6 models were as follows:

Mass stability
Models Protein Test value at first time Test value after 24hours D
Repeat 1 Repeat 2 Repeat 3 Repeat 1 Repeat 2 Repeat 3
Autof ms Insulin 5808.618 5808.505 5808.788 5808.785 5808.601 5808.643 7
600 Cytochrom 12362.949 12363.760 12362.056 12363.225 12363.702 12363.061 33
eC
Autof ms Insulin 5808.632 5808.654 5808.54 5808.504 5808.711 5808.832 13
800 Cytochrom 12362.979 12362.85 12362.899 12362.964 12362.937 12362.965 4
eC
Autof ms Insulin 5808.483 5808.555 5808.576 5808.530 5808.399 5808.702 1
1000 Cytochrom 12363.348 12362.277 12362.591 12363.671 12362.511 12362.808 21
eC
Autof ms Insulin 5808.350 5808.476 5808.451 5808.625 5808.975 5808.701 59
1600 Cytochrom 12363.032 12362.979 12362.794 12362.211 12363.491 12362.888 6
eC
Autof ms Insulin 5808.319 5808.358 5808.855 5808.723 5808.540 5808.376 6
2000 Cytochrom 12363.869 12363.277 12362.278 12362.037 12363.522 12363.704 4
eC

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Autof ms Insulin 5808.46 5808.677 5808.543 5808.671 5808.551 5808.595 8
2600 Cytochrom 12362.452 12363.14 12362.945 12362.886 12362.576 12362.917 4
eC
Conclusion: According to the above results, the mass stability of the 6 models met the criteria.

4.1.6. Identification accuracy

The results of identification accuracy on Autof ms 600 were as follows:

Result
Identificatio
Strains Sampl Sampl Sampl Sampl Sampl Sampl n score
e1 e2 e3 e4 e5 e6
Enterococcus
9.669 9.637 9.680 9.672 9.759 9.679 9.637
faecalis(ATCC51299)
Escherichia
9.678 9.721 9.688 9.678 9.737 9.718 9.678
coli(ATCC25922)
Enterococcus
9.704 9.749 9.718 9.761 9.740 9.728 9.704
faecium(ATCC19434)
Staphylococcus
9.733 9.708 9.736 9.739 9.643 9.734 9.634
aureus(ATCC29213)
Bacteroides fragilis(ATCC
9.665 9.681 9.734 9.714 9.736 9.750 9.665
25285)
Pseudomonas
9.608 9.627 9.635 9.625 9.630 9.634 9.608
aeruginosa(ATCC27853)
Candida parapsilosis(ATCC
9.614 9.503 9.668 9.619 9.611 9.662 9.503
22019)

The results of identification accuracy on Autof ms 800 were as follows:

Result
Identificatio
Strains Sampl Sampl Sampl Sampl Sampl Sampl
n score
e1 e2 e3 e4 e5 e6
Enterococcus
9.650 9.667 9.727 9.678 9.659 9.656 9.650
faecalis(ATCC51299)
Escherichia
9.624 9.688 9.713 9.617 9.627 9.612 9.612
coli(ATCC25922)
Enterococcus
9.714 9.749 9.717 9.739 9.747 9.737 9.714
faecium(ATCC19434)
Staphylococcus
9.701 9.727 9.688 9.662 9.611 9.718 9.611
aureus(ATCC29213)
Bacteroides fragilis(ATCC
9.742 9.757 9.732 9.710 9.704 9.717 9.704
25285)
Pseudomonas
9.537 9.569 9.619 9.614 9.634 9.567 9.537
aeruginosa(ATCC27853)
Candida parapsilosis(ATCC
9.650 9.682 9.657 9.691 9.615 9.614 9.614
22019)

The results of identification accuracy on Autof ms 1000 were as follows:

Result Identificatio
Strains
Sample 1 Sample 2 Sample 3 Sample 4 Sample 5 Sample 6 n score
Enterococcus
9.679 9.684 9.686 9.695 9.734 9.678 9.678
faecalis(ATCC51299)
Escherichia 9.649 9.727 9.759 9.688 9.712 9.740 9.649

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coli(ATCC25922)
Enterococcus
9.694 9.628 9.721 9.759 9.737 9.736 9.628
faecium(ATCC19434)
Staphylococcus
9.759 9.792 9.782 9.768 9.794 9.789 9.759
aureus(ATCC29213)
Bacteroides
9.702 9.724 9.736 9.723 9.759 9.775 9.702
fragilis(ATCC 25285)
Pseudomonas
aeruginosa(ATCC27853 9.656 9.644 9.557 9.623 9.648 9.669 9.623
)
Candida
parapsilosis(ATCC 9.644 9.663 9.653 9.667 9.666 9.678 9.644
22019)

The results of identification accuracy on Autof ms 1600 were as follows:

Result
Identificatio
Strains Sampl Sampl Sampl Sampl Sampl Sampl
n score
e1 e2 e3 e4 e5 e6
Enterococcus
9.624 9.684 9.627 9.656 9.602 9.624 9.602
faecalis(ATCC51299)
Escherichia
9.720 9.763 9.717 9.718 9.748 9.711 9.711
coli(ATCC25922)
Enterococcus
9.749 9.760 9.692 9.789 9.784 9.739 9.692
faecium(ATCC19434)
Staphylococcus
9.723 9.740 9.721 9.711 9.743 9.755 9.711
aureus(ATCC29213)
Bacteroides fragilis(ATCC
9.717 9.717 9.782 9.779 9.763 9.662 9.662
25285)
Pseudomonas
9.688 9.744 9.694 9.694 9.688 9.749 9.688
aeruginosa(ATCC27853)
Candida parapsilosis(ATCC
9.723 9.694 9.595 9.715 9.643 9.702 9.595
22019)

The results of identification accuracy on Autof ms 2000 were as follows:

Result
Identificatio
Strains Sample Sample Sample Sample Sample Sample
n score
1 2 3 4 5 6
Enterococcus
9.553 9.538 9.587 9.595 9.506 9.518 9.506
faecalis(ATCC51299)
Escherichia coli(ATCC25922) 9.666 9.572 9.561 9.550 9.630 9.619 9.550
Enterococcus
9.670 9.662 9.720 9.630 9.682 9.643 9.630
faecium(ATCC19434)
Staphylococcus
9.701 9.657 9.654 9.672 9.679 9.637 9.637
aureus(ATCC29213)
Bacteroides fragilis(ATCC
9.467 9.623 9.596 9.507 9.694 9.518 9.467
25285)
Pseudomonas
9.633 9.630 9.555 9.323 9.521 9.614 9.323
aeruginosa(ATCC27853)
Candida parapsilosis(ATCC
9.526 9.467 9.325 9.479 9.548 9.417 9.325
22019)

The results of identification accuracy on Autof ms 2600 were as follows:

Strains Result Identification
Sample Sample Sample Sample Sampl Sample 6 score

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1 2 3 4 e5
Enterococcus
9.648 9.712 9.683 9.689 9.673 9.672 9.648
faecalis(ATCC51299)
Escherichia coli(ATCC25922) 9.659 9.691 9.705 9.696 9.678 9.684 9.659
Enterococcus
9.739 9.733 9.734 9.758 9.781 9.757 9.733
faecium(ATCC19434)
Staphylococcus
9.715 9.720 9.711 9.727 9.724 9.695 9.695
aureus(ATCC29213)
Bacteroides fragilis(ATCC
9.619 9.710 9.727 9.695 9.673 9.707 9.619
25285)
Pseudomonas
9.612 9.583 9.670 9.672 9.659 9.643 9.583
aeruginosa(ATCC27853)
Candida parapsilosis(ATCC
9.646 9.666 9.653 9.420 9.656 9.662 9.420
22019)
Conclusion: According to the above results, the identification accuracy of the 6 models met the
criteria.

4.2 Grounding impedance test

The results of 6 models were as follows:

Model type Criteria Result (mΩ)
Autof ms600 76
Autof ms800 58
Autof ms1000 58
<100mΩ
Autof ms1600 72
Autof ms2000 78
Autof ms2600 55
Conclusion: According to the above results, the grounding impedance result of the 6 modules
met the criteria.

4.3 Dielectric strength test

The results of 6 models were as follows:

Model type Basic insulation Result Double insulation Result
Autof ms600 Pass Pass
Autof ms800 Pass Pass
Autof ms1000 Pass Pass
1390V 2230V
Autof ms1600 Pass Pass
Autof ms2000 Pass Pass
Autof ms2600 Pass Pass
Conclusion: According to the above results, the Dielectric strength result of the 6 models met the
criteria.

4.4 Contract current test

The results of 6 models were as follows:

Contact current
Current value
value under Result Result
Model type under single
normal (mA) (mA)
failure condition
conditions
Autof ms600 <0.5mA 0.03 <3.5mA 2.237
Autof ms800 0.03 2.282
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Autof ms1000 0.03 2.310

Autof ms1600 0.03 2.260
Autof ms2000 0.03 2.327
Autof ms2600 0.03 2.254

Conclusion: Conclusion: According to the above results, the contract current result of the 6
models met the criteria.

5. Conclusion

According to the results above, the performance parameter and electric safety of 6 models of
Automated Mass Spectrometry Microbial Identification System can meet the criteria, there
is no difference between the 6 models during the usage.

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