SuperFlex

Automated Chemiluminescent Immunoassay Analyzer

Flexible Powerful

NMPA & CE-IVD both Available

SuperFlex Overview
DESCRIPTION
Product Name SuperFlex
Direct chemiluminescent immunoassay
Methods based on magnetic beads (Acridinium
Analytical units ester)
Throughput 60 tests/hour
Sample type Serum, Plasma, Whole blood
2 racks to load up to 24 patient samples,
Sample positions
controls and calibrators
615mm
Results 5-15 mins
Analytical Units 12 independent channels
Sample volume 20ul-100uL
792mm 670mm
Dimensions
615X792X670 mm
(HxWxD)
Net Weight 78Kg
Sample positions
Operation Color touchscreen（Chinese/English）
Calibration When change to a new lot

Leading Mechanism
● Outstanding properties of
M-PVA Magnetic beads as
CLIA reaction carriers.
● Dynamically capture
targets（Ab/Ag）
SuperFlex Features
Flexible Detection
SuperFlex integrates 12
independent channels to
execute incubation reaction
and beads transfer, that can
be used flexibly in batch or
single mode.
Single-use reagents
A SuperFlex test strip contains
everything needed to perform an
immunoassay.
● Less waste with unitized reagent
packing
● Eliminate cross-contamination
 Easy to use ----Sample tube-in Result-out

①Scan samples barcode ②Click to run ③Click to print reports

Key End Markets & Applications

Central Lab/Clinical Lab

• Need the ability to quantitatively detect CRP,
PCT, cTnI, MYO, CK-MB and NT-proBNP
• Fast flexible precise characteristics are needed

Emergency/Cardiology Dep
• Need the ability to quantitatively detect CRP, PCT,
cTnI, MYO, CK-MB and NT-proBNP
• Small fast flexible precise characteristics are
needed

To serve patients with chest pain(acute coronary syndrome), heart failure, infection( Sepsis)
Assay menu on SuperFlex
TAT
Assay name Linearity Precision LoD NMPA CE-IVD
(min)

PCT(ng/ml) 15 0.05-200 CV≤8% 0.05 Y 2021.01

CRP(mg/L) 5 0.5-200 CV≤8% 0.1 Y 2021.01

CKMB(ng/ml) 15 0.3-300 CV≤8% 0.3 Y 2021.01

cTnI(ng/ml) 15 0.01-100 CV≤8% ≤0.01 Y 2021.01

MYO(ng/ml) 5 1-3000 CV≤8% ≤1.0 Y 2020.03

NT-proBNP
15 15-30000 CV≤8% 15 Y 2021.01
(pg/ml)

Anti-SARS-CoV-2 IgG 15 / / / N 2020.07

D-Dimer CV≤8%
15 0.1-80 0.1 2022.Q1 N/A
(mg/L)
Control Kits
CV≤8%
(PCT/CRP/CKMB/cTnI/MYO/NT- Y N/A
proBNP)
SuperFlexTM Anti-SARS-CoV-2 IgG detection

Test Anti-SARS-CoV-2 IgG Assay

Package 50 Tests/Kit

Ag information S1 protein

Sample Type Serum, Plasma, Whole blood

Sample Volume 20ul

Assay time (sample to result) 15min

Negative coincidence rate 98%

Positive coincidence rate 94%

SuperFlexTM Anti-SARS-CoV-2 IgG detection
SuperFlexTM Anti-SARS-CoV-2 IgG Testing data
of samples from NCCL

High sensitivity and specificity

SuperFlexTM Anti-SARS-CoV-2 IgG Testing data
of samples from Wuhan blood bank

• PerkinElmer VS Wantai
biopharm, A NMPA approved
product

• At Wuhan blood bank，positive

rate of IgG is more than 5%（up
to 10%）

• PerkinElmer S/CO value can be

used for semi-quantification
 SuperFlex Cardiac Troponin I kit grade

Company/ Platform/ Assay 99th percentile , ng/mL 10% CV, ng/mL

SuperFlex Cardiac Troponin I 0.0258 0.0067

Acceptance designation Total imprecision at the 99th percentile, Test results

CV%

Guideline acceptable ≤10 7.24

Clinical usable ＞10 to ≤20

Not acceptable ＞20

Assay designation Measurable normal values below the 99th Test results
percentile, %
Level 4 (third generation, hs) ≥95

Level 3 (second generation, hs) 75 to ＜95 82.57

Level 2 (first generation, hs) 50 to ＜75

Level 1 (contemporary) ＜50

11
 Definition of highly sensitive cTnI and its clinical significance

• The likely clinical effects of using assays rated as guideline

acceptable or clinically usable by the scorecard are

• (1) emergency medicine physicians will achieve improvements in triage

through earlier ruling out (improved specificity) and ruling in (improved
sensitivity) of MI patients;

• (2) cardiology and internal medicine physicians will see improved

outcomes for both inpatients (hospitalized, short-term risk) and outpatients
(posthospitalization, long-term risk);

• (3) other medical specialty physicians will be better able to identify

patients, often without clinical symptoms, who may be at risk of cardiac
related adverse outcomes;

• (4) clinical trial investigators will be able to identify appropriate and optimal
patient enrollment and outcome measures.

12
 Method comparison

Method comparison with Beckman Access AccuTnI Method comparison with Siemens TNI-Ultra
100 100

80
75

PKI(ng/mL)
PKI(ng/mL)

60
50 Passing-Bablok fit
Passing-Bablok fit (y = 0.004846 + 0.7154 x)
40
(y = -0.0002872 + 1.01 x)

25
20

0 0
0 20 40 60 80 100 0 25 50 75 100 125
Beckman (ng/mL) Siemens (ng/mL)

N 105 N 195
Minimum Maximum Minimum Maximum
Beckman 0.01 94.15000 Siemens 0 123.78
PKI 0.01 95.03000 PKI 0.002 96.57
Correlation - r 0.9999 Correlation - r 0.988
Passing-Bablok fit Passing-Bablok fit
Equation PKI = -0.0002872 + 1.01Beckman Equation PKI = 0.004846 + 0.7154 Siemens
Bootstrap 95% Bootstrap 95%
Parameter Estimate CI Parameter Estimate CI
to 3.029E- Intercept 0.0048 0.004 to 0.005
Intercept -2.872E-04 -0.003508
04
Slope 0.7154 0.6818 to 0.7750
Slope 1.010 0.9875 to 1.079
CI based on 999 bootstrap samples.
CI based on 999 bootstrap samples.

13
 Clinical test result with high-risk AMI samples

1
• A total of 200 citrated plasma were tested in this study,
0.9 including 40 patients with AMI, age from 36 to 91 years old,
0.8 30 male patients and 10 female patients, which were

0.7 tested positive, and 160 patients without AMI, 30 were

tested positive.
TPF (Sensitivity)

0.6
No discrimination
• According to CLSI GP10-A, ROC scatter plots were used
0.5
PKI CTNI
(0.974)
to analyze the results from clinical data as the left figure,
0.4
the Cutoff value of SuperFlex Cardiac Troponin I kit
0.3
diagnostic for AMI was determined to be 0.5ng/mL.
0.2
• The following table summarizes the sensitivity and
0.1 specificity of the SuperFlex Cardiac Troponin I kit.
0
Sensitivity Specificity
0 0.2 0.4 0.6 0.8 1
FPF (1 - Specificity)
SuperFlex cTnI 100% 81.25%
Positive Negative Total
Judgment 40 160 200 Number of 40 160
patients
AUC 95% CI SE 95% CI 91.24%-100% 74.50%-89.29%
PKI CTNI 0.974 0.955 to 0.992 0.0095

14
 Installation of SuperFlex

China mainland（>100 units） Overseas

15
Thanks
BACK UP SLIDES

FROM R&D
SuperFlex All in One CRP Assay
Method Comparison of SuperFlex CRP against BodiTech CRP using Whole Blood
• Correlation • T-test
Hypothesized difference 0
Correlation (Passing-Bablok fit)
175

PKD SuperFlex All in One CRP, mg/L

t statistic -0.78
150 DF 39
125 p-value 0.4372

100
Acceptable Criteria P≥0.05
75
Result P=0.4372
50 Statistically comparable
25

0
0 25 50 75 100 125 150 175
BodiTech i-Chroma All in One CRP, mg/L

BodiTech i-Chroma
Minimum
0.510
Maximum
171.635
• Coincidence rate & Chi-Square test
PKD SuperFlex 0.627 151.284
Correlation - r 0.992 Positive 100%
Negative 100%
Acceptable Criteria r≥0.99
Total 100%
Result r=0.992

• Imprecision Kappa
Wald 95% CI
1.00
1.00 to 1.00
1 sample with concentration near cut-off value was tested 12 SE 0.000
times; CV was calculated

N 12 Acceptable Criteria Kappa close to 1

Acceptable Criteria CV≤8% Result Kappa=1.00
Result CV=4.65%
SuperFlex PCT Assay
Comparison of Whole Blood Results against Plasma Results using SuperFlex (each whole
blood-plasma pair is collected at same time from same donor)

• Correlation • T-test
Hypothesized difference 0
40
Correlation (Passing-Bablok fit)
35 t statistic 0.39
DF 54
Whole Blood, ng/ml
30 p-value 0.6978
25
20 Acceptable Criteria P≥0.05
15 Result P=0.6978
Statistically comparable
10
5
0
0 5 10 15 20 25 30 35 40
Plasma, ng/ml

Plasma
Minimum
0.050
Maximum
38.030
• Coincidence rate & Chi-Square test
Whole Blood 0.040 38.580
Correlation - r 0.992 Positive 100%
Negative 100%
Acceptable Criteria r≥0.99
Total 100%
Result r=0.992

• Imprecision Kappa
Wald 95% CI
1.00
1.00 to 1.00
1 sample with concentration near cut-off value was tested 12 SE 0.000
times; CV was calculated

N 12 Acceptable Criteria Kappa close to 1

Acceptable Criteria CV≤8% Result Kappa=1.00
Result CV=4.13%
SuperFlex MYO Assay
Comparison of Whole Blood Results against Plasma Results using SuperFlex (each whole
blood-plasma pair is collected at same time from same donor)

• Correlation • T-test
Hypothesized difference 0
Correlation (Passing-Bablok fit)
3000
t statistic 1.29
2500 DF 49
Whole Blood,ng/ml p-value 0.2026
2000

1500 Acceptable Criteria P≥0.05

Result P=0.2026
1000
Statistically comparable
500

0
0 500 1000 1500 2000 2500 3000
Plasma,ng/ml

Plasma
Minimum
11.420
Maximum
2891.290
• Coincidence rate & Chi-Square test
Whole Blood 12.790 2878.950
Correlation - r 0.997 Positive 100%
Negative 100%
Acceptable Criteria r≥0.99
Total 100%
Result r=0.997

• Imprecision Kappa
Wald 95% CI
1.00
1.00 to 1.00
1 sample with concentration near cut-off value was tested 12 SE 0.000
times; CV was calculated

N12 Acceptable Criteria Kappa close to 1

Acceptable Criteria CV≤8% Result Kappa=1.00
Result CV=5.09%
SuperFlex CK-MB Assay
Comparison of Whole Blood Results against Plasma Results using SuperFlex (each whole
blood-plasma pair is collected at same time from same donor)

• Correlation • T-test
Hypothesized difference 0
Correlation (Passing-Bablok fit)
350
t statistic -0.49
300 DF 49
Whole Blood,ng/ml p-value 0.6265
250

200
Acceptable Criteria P≥0.05
150
Result P=0.6265
100 Statistically comparable
50

0
0 50 100 150 200 250 300 350
Plasma,ng/ml

Plasma
Minimum
1.890
Maximum
295.450
• Coincidence rate & Chi-Square test
Whole Blood 1.920 305.500
Correlation - r 1.000 Positive 100%
Negative 100%
Acceptable Criteria r≥0.99
Total 100%
Result r=1.000

• Imprecision Kappa
Wald 95% CI
1.00
1.00 to 1.00
1 sample with concentration near cut-off value was tested 12 SE 0.000
times; CV was calculated

N 12 Acceptable Criteria Kappa close to 1

Acceptable Criteria CV≤8% Result Kappa=1.00
Result CV=2.27%
SuperFlex cTnI Assay
Comparison of Whole Blood Results against Plasma Results using SuperFlex (each whole
blood-plasma pair is collected at same time from same donor)

• Correlation • T-test
Hypothesized difference 0
80
Correlation (Passing-Bablok fit)
70 t statistic 0.27
DF 49
Whole Blood,ng/ml 60
p-value 0.7849
50
40 Acceptable Criteria P≥0.05
30 Result P=0.7849
20 Statistically comparable

10
0
0 10 20 30 40 50 60 70 80
Plasma,ng/ml

Plasma
Minimum
0.010
Maximum
75.280
• Coincidence rate & Chi-Square test
Whole Blood 0.008 69.190
Correlation - r 0.998 Positive 100%
Negative 100%
Acceptable Criteria r≥0.99
Total 100%
Result r=0.998

• Imprecision Kappa
Wald 95% CI
1.00
1.00 to 1.00
1 sample with concentration near cut-off value was tested 12 SE 0.000
times; CV was calculated

N 12 Acceptable Criteria Kappa close to 1

Acceptable Criteria CV≤8% Result Kappa=1.00
Result CV=4.33%
SuperFlex NT-proBNP Assay
Comparison of Whole Blood Results against Plasma Results using SuperFlex (each whole
blood-plasma pair is collected at same time from same donor)

• Correlation • T-test
Hypothesized difference 0
12000
Correlation (Passing-Bablok fit)
t statistic -1.32
10000 DF 48
Whole blood,pg/ml
p-value 0.1941
8000

6000 Acceptable Criteria P≥0.05

Result P=0.1941
4000
Statistically comparable
2000

0
0 2000 4000 6000 8000 10000 12000
Plasma,pg/ml

Plasma
Minimum Maximum
34.100 10651.500
• Coincidence rate & Chi-Square test
Whole Blood 27.000 9386.400
Correlation - r 0.996 Positive 100%
Negative 100%
Acceptable Criteria r≥0.99
Total 100%
Result r=0.996

• Imprecision Kappa
Wald 95% CI
1.00
1.00 to 1.00
1 sample with concentration near cut-off value was tested 12 SE 0.000
times; CV was calculated

N 12 Acceptable Criteria Kappa close to 1

Acceptable Criteria CV≤8% Result Kappa=1.00
Result CV=5.82%
Detail Performance Data for 6 assay
Result
Project Item Criteria
Lot1 Lot2 Lot3
Linearity r≥0.99(1.0~3000) 1.0000 0.9998 0.9999
Intra-Lot CV≤8% 4.42% 1.88% 3.23%
Precision
Between Lot CV≤10% 8.11%
LoB ≤1 0.24 0.69 0.12
MYO(ng/mL)
±20%(L target:48.2) 43.49 50.47 44.73
Accuracy(L,M,H) ±20%(M target:251.53) 236.61 253.24 242.5
±20%(H target:1072.2) 1023.06 1106.2 1086.53
Method Comparation r≥0.9 with Beckman 0.9569 0.9417 0.9684
Linearity r≥0.99(0.3~300) 1.0000 1.0000 1.0000
Intra-Lot CV≤8% 1.44% 2.38% 1.79%
Precision
Between Lot CV≤10% 2.15%
LoB ≤0.3 0.009 0.015 0.000
CK-MB(ng/mL)
±20%(L target:6.46) 6.439 6.046 7.034
Accuracy(L,M,H) ±20%(M target:29.56) 29.508 28.784 29.343
±20%(H target:139.284) 144.822 153.446 147.375
Method Comparation r≥0.9 with Beckman 0.9894 0.9829 0.9905
Linearity r≥0.99(0.05~200) 1.0000 0.9999 1.0000
Intra-Lot CV≤8% 3.63% 3.37% 3.04%
Precision
Between Lot CV≤10% 4.21%
PCT(ng/mL)
LoB ≤0.02 0.000 0.000 0.000
±20%(L target:0.48) 0.47 0.49 0.5
Accuracy(L,M)
±20%(M target:9) 9.46 10.09 9.19
Linearity r≥0.99(0.5~200) 0.9995 0.9953 0.9922
Intra-Lot CV≤8% 4.08% 3.72% 4.57%
Precision
Between Lot CV≤10% 6.42%
CRP(mg/L) LoB ≤0.05 0.000 0.000 0.000
±10%(L target:1.35) 1.37 1.27 1.22
Accuracy(L,M)
±10%(M target:13.5) 13.56 13.44 12.17
Method Comparation r≥0.95 with i-chroma 0.977 0.9886 0.9911
Linearity r≥0.99(15~30000) 0.9997 0.9992 0.9999
Intra-Lot CV≤8% 4.47% 7.05% 4.55%
Precision
Between Lot CV≤15% 8.14%
NT-proBNP(pg/mL) LoB ≤5 0.000 0.560 0.040
±10%(L target:186.7) 172.37 177.91 178.15
Accuracy(L,M,H)
±10%(M target:1093.2) 1006.63 996.07 1023.29
Method Comparation r≥0.9 with roche 0.9437 0.9328 0.9487
Linearity r≥0.99(0.01~100) 0.9998 0.9999 0.9996
Intra-Lot CV≤8% 1.41% 2.56% 2.75%
Precision
Between Lot CV≤10% 6.24%
cTnI(ng/mL) LoB ≤0.01 0.004 0.000 0.002
±20%(L target:0.38) 0.432 0.357 0.407
Accuracy(L,M,H)
±20%(M target:3.71) 3.736 3.769 3.339
Method Comparation r≥0.9 with Beckman 0.9919 0.9831 0.9984