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FIA Meter Plus (FS-113)
Fluorescence Immunoassay Analyzer
Test Item
Speci Specimen
Volume
men
Type
Measuring
Range
Clinical
Reference
Qualification
Coagulation
D-Dimer WB/Plasma 0.1-10 mg/L 0-0.5 mg/L
WB/Serum/Plasma
Tumor
Markers
AFP 5-400 ng/mL 0-20 ng/mL
PSA WB/Serum/Plasma
WB/Serum/Plasma
2-100 ng/mL 0-4 ng/mL
CEA 1-500 ng/mL 0-5 ng/mL
WB/Serum/Plasma
fPSA 0.2-30 ng/mL < 1 ng/mL
WB/Serum/Plasma
Diabetic
& Renal
Injury
Markers
HbA1c WB 4.0-14.5% 4-6.5%
MAU Urine 5-300 mg/L 0-20 mg/L
CysC 0.2-10 mg/L 0.5-1.1 mg/L
WB/Serum/Plasma
Urine 10-1500 ng/mL ≤131.7 ng/mL
0.3-20 mg/L 1.0-2.7 mg/L
NGAL
β2-MG
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
Cardiac
Markers
NT-proBNP 18-35000 pg/mL
<75 years old, 0-300 pg/mL
≥75 years old, 0-450 pg/mL
cTn I 0.1-50 ng/mL 0-0.3 ng/mL
Myo 2.0-400 ng/mL 0-58 ng/mL
CK-MB 0.3-100 ng/mL 0-5 ng/mL
H-FABP 1-120 ng/mL
5-5000 pg/mL 0-100 pg/mL
≤1.0 mg/L
0-7 ng/mL
3 in 1
(cTn I/Myo/CK-MB)
Same with
single items
Same with
single items
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
WB/Plasma
D-Dimer one step WB/Plasma 0.1-10 mg/L 0-0.5 mg/L
BNP
hsCRP
TnT
2 in 1
(cTn I/ NT-proBNP)
Same with
single items
0.1-10 mg/L
Same with
single items
Inflammation
Markers
PCT WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
0.1-100 ng/mL
1.0-300 mg/L 0-10 mg/L
0-0.5 ng/mL
CRP
(hsCRP+CRP)
WB/Serum/Plasma
0.5-200 mg/L
CRP:0.5-150 mg/L
PCT:0.1-100 ng/mL
CRP:<10 mg/L
PCT:<0.5 ng/mL
CRP:0-10 mg/L
hsCRP:0-1 mg/L
SAA
2 in 1
(CRP+PCT)
Ongoing: Ferritin, FOB, H.Pylori antigen, Vit-B12, ST2
WB/Serum/Plasma
Fertility
2-200,000 mIU/mL
β-HCG 5 mIU/mL
WB/Serum/Plasma 1-100 mIU/mL
LH
Male: 1.70-8.60 mIU/mL;
Female:
Follicular phase :2.95-13.65 mIU/mL
Ovulation phase:13.65-95.75 mIU/mL
Luteal phase:1.25-11.00 mIU/mL
Menopause phase:8.24-55.23 mIU/mL
WB/Serum/Plasma 1-100 mIU/mL
Male: 1.50-12.40 mIU/mL
Female:
Follicular phase :4.46-12.43 mIU/mL
Ovulation phase:4.88-20.96 mIU/mL
Luteal phase:1.96-7.70 mIU/mL
Menopause phase: 22.70-130.00 mIU/mL
FSH
WB/Serum/Plasma
WB/Serum/Plasma 0.1-16 ng/mL
AMH
Male: 20-60 years old, 0.92-13.89 ng/mL
Female:20-29 years old, 0.88-10.35 ng/mL
30-39 years old, 0.31-7.86 ng/mL 40-50 years old, ≤5.07 ng/mL
1.5-60 ng/mL
Prog
Male: 0.2-1.5 ng/mL
Female:
Follicular phase: 0.2-2.0 ng/mL
Ovulation phase: 0.7-3.5 ng/mL
Luteal phase: 3.0-30 ng/mL
Menopause phase: 0.1-0.9 ng/mL
7 weeks of pregnancy: 24.5±7.6 ng/mL
9-12 weeks of pregnancy: 38.0±13.0 ng/mL
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
1-200 ng/mL
9-3000 pg/mL
0.2-15 ng/mL
PRL
E2
Testosterone
Female(non-pregnant): 4.60-25.07 ng/mL
Male: 3.45-17.42 ng/mL
Male: <85 pg/mL
Female:
Follicular Phase: 12-262 pg/mL
Ovulation: 40-396 pg/mL
Luteal Phase: 21-381 pg/mL
Menopause: <190 pg/mL
Pregnancy: >145 pg/mL
Male: 20-49 years old, 1.61-8.41 ng/mL
≥50 years old, <0.61 ng/mL
Female: 20-49 years old, ≤0.80 ng/mL
≥50 years old, <0.71 ng/mL
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
T3 0.61-9.22 nmol/L
12.87-300 nmol/L
0.1-100 mIU/L
1.23-3.07 nmol/L
66-181 nmol/L
0.3-4.2 mIU/L
T4
TSH
fT3 WB/Serum/Plasma
0.40-50.00 pmol/L or
0.26-32.55 pg/mL
2.8-7.1 pmol/L
(1.82-4.61 pg/mL)
fT4 WB/Serum/Plasma
1.00-100 pmol/L or
0.078-7.77 ng/dL
12-22 pmol/L
(0.94-1.72 ng/dL)
Thyroid
Function
Cortisol WB/Serum/Plasma 50-1000 nmol/L
7:00-10:00 a.m.: 201.31-536.54 nmol/L
4:00-8:00 p.m.: 65.78-330.85 nmol/L
Others
Serum/Plasma 75 μL
10 μL
75 μL
10 μL
75 μL
10 μL
75 μL
75 μL
75 μL
75 μL
75 μL
20 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
10 μL
100 μL for whole blood
75 μL for plasma/serum
5-100 ng/mL 30-100 ng/mL
Vitamin D
Reaction
Time
5 min
15 min
15 min
15 min
15 min
5 min
3 min
5 min
15 min
10 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
3 min
15 min
15 min
15 min
3 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
15 min
Vitamin
CE
CE
CE
IFCC NGSP
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
CE
75 μL 10-1000 ng/mL <225 ng/mL
Lp-PLA2 15 min
0123
CE
0123
CE
CE
CE
15 μL for whole blood
10 μL for plasma
100 μL for whole blood
75 μL for plasma
75 μL for whole blood
50 μL for plasma/serum
8.5 μL for whole blood
5 μL for plasma/serum
75 μL
75 μL
75 μL
75 μL
75 μL
75 μL
<0.2 ng/mL
S100β WB/Serum/Plasma 0.05-10 ng/mL
Craniocerebral
Injury Markers 15 min
75 μL
10 μL
3~4000 pg/mL ≤10 pg/mL
WB/Serum/Plasma
IL-6 15 min
75 μL
0.03-10 ng/mL 0-0.1 ng/mL
Category Test Item
Speci Specimen
Volume
men
Type
Measuring
Range
Clinical
Reference
Qualification
Reaction
Time
Category
WB/Serum/Plasma
WB/Serum/Plasma
WB/Serum/Plasma
10 μL
10 μL
Qualitative
Qualitative
Negative
Negative
SARS-CoV-2 IgM
SARS-CoV-2 Antibody
10 min
10 min
CE
CE
10 μL Qualitative Negative
SARS-CoV-2 IgM/IgG 10 min
COVID-19
CE
FIA METER PLUS
Inner
Temperature
Control
APPLICATION
TEST PROCEDURE
FS-113
Mixing Dropping
Sampling Reading
Serum
or Plasma
or Whole blood
Buffer
75μL
Dropping
Laboratory ER ICU Clinics GP Office Ambulance
• Dimension: 270*238*146mm
• Weight: 2.8 Kg
Portable
Easy to operate
Get results in
3-15 minutes
Provide better
reaction condition
Good correlation
with CLIA method
Built-in Thermal Printer
Real-time auto-printing •
Support for external printers •
Large Display
8" LCD Touch Screen •
Intuitive user interface •
Test Channel
Multiple testing modes available •
Unique quick mode for large number of samples •
Test Reagent
Room temperature storage •
Suitable for whole blood, serum, plasma and urine •
Connection
• Direct connection to LIS/HIS
ID chip inlet
• Automatically reading of batch number and
calibration information in the ID chip
Designed Sampler
• Specially-designed sampler for small volume
of specimen
Convenient Rapid Test
Temperature
control
Reliable
Accuracy
3-15min
ID CARD

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FINECARE-METER-PLUS.pdf

  • 1. FIA Meter Plus (FS-113) Fluorescence Immunoassay Analyzer Test Item Speci Specimen Volume men Type Measuring Range Clinical Reference Qualification Coagulation D-Dimer WB/Plasma 0.1-10 mg/L 0-0.5 mg/L WB/Serum/Plasma Tumor Markers AFP 5-400 ng/mL 0-20 ng/mL PSA WB/Serum/Plasma WB/Serum/Plasma 2-100 ng/mL 0-4 ng/mL CEA 1-500 ng/mL 0-5 ng/mL WB/Serum/Plasma fPSA 0.2-30 ng/mL < 1 ng/mL WB/Serum/Plasma Diabetic & Renal Injury Markers HbA1c WB 4.0-14.5% 4-6.5% MAU Urine 5-300 mg/L 0-20 mg/L CysC 0.2-10 mg/L 0.5-1.1 mg/L WB/Serum/Plasma Urine 10-1500 ng/mL ≤131.7 ng/mL 0.3-20 mg/L 1.0-2.7 mg/L NGAL β2-MG WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma Cardiac Markers NT-proBNP 18-35000 pg/mL <75 years old, 0-300 pg/mL ≥75 years old, 0-450 pg/mL cTn I 0.1-50 ng/mL 0-0.3 ng/mL Myo 2.0-400 ng/mL 0-58 ng/mL CK-MB 0.3-100 ng/mL 0-5 ng/mL H-FABP 1-120 ng/mL 5-5000 pg/mL 0-100 pg/mL ≤1.0 mg/L 0-7 ng/mL 3 in 1 (cTn I/Myo/CK-MB) Same with single items Same with single items WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma WB/Plasma D-Dimer one step WB/Plasma 0.1-10 mg/L 0-0.5 mg/L BNP hsCRP TnT 2 in 1 (cTn I/ NT-proBNP) Same with single items 0.1-10 mg/L Same with single items Inflammation Markers PCT WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma 0.1-100 ng/mL 1.0-300 mg/L 0-10 mg/L 0-0.5 ng/mL CRP (hsCRP+CRP) WB/Serum/Plasma 0.5-200 mg/L CRP:0.5-150 mg/L PCT:0.1-100 ng/mL CRP:<10 mg/L PCT:<0.5 ng/mL CRP:0-10 mg/L hsCRP:0-1 mg/L SAA 2 in 1 (CRP+PCT) Ongoing: Ferritin, FOB, H.Pylori antigen, Vit-B12, ST2 WB/Serum/Plasma Fertility 2-200,000 mIU/mL β-HCG 5 mIU/mL WB/Serum/Plasma 1-100 mIU/mL LH Male: 1.70-8.60 mIU/mL; Female: Follicular phase :2.95-13.65 mIU/mL Ovulation phase:13.65-95.75 mIU/mL Luteal phase:1.25-11.00 mIU/mL Menopause phase:8.24-55.23 mIU/mL WB/Serum/Plasma 1-100 mIU/mL Male: 1.50-12.40 mIU/mL Female: Follicular phase :4.46-12.43 mIU/mL Ovulation phase:4.88-20.96 mIU/mL Luteal phase:1.96-7.70 mIU/mL Menopause phase: 22.70-130.00 mIU/mL FSH WB/Serum/Plasma WB/Serum/Plasma 0.1-16 ng/mL AMH Male: 20-60 years old, 0.92-13.89 ng/mL Female:20-29 years old, 0.88-10.35 ng/mL 30-39 years old, 0.31-7.86 ng/mL 40-50 years old, ≤5.07 ng/mL 1.5-60 ng/mL Prog Male: 0.2-1.5 ng/mL Female: Follicular phase: 0.2-2.0 ng/mL Ovulation phase: 0.7-3.5 ng/mL Luteal phase: 3.0-30 ng/mL Menopause phase: 0.1-0.9 ng/mL 7 weeks of pregnancy: 24.5±7.6 ng/mL 9-12 weeks of pregnancy: 38.0±13.0 ng/mL WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma 1-200 ng/mL 9-3000 pg/mL 0.2-15 ng/mL PRL E2 Testosterone Female(non-pregnant): 4.60-25.07 ng/mL Male: 3.45-17.42 ng/mL Male: <85 pg/mL Female: Follicular Phase: 12-262 pg/mL Ovulation: 40-396 pg/mL Luteal Phase: 21-381 pg/mL Menopause: <190 pg/mL Pregnancy: >145 pg/mL Male: 20-49 years old, 1.61-8.41 ng/mL ≥50 years old, <0.61 ng/mL Female: 20-49 years old, ≤0.80 ng/mL ≥50 years old, <0.71 ng/mL WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma T3 0.61-9.22 nmol/L 12.87-300 nmol/L 0.1-100 mIU/L 1.23-3.07 nmol/L 66-181 nmol/L 0.3-4.2 mIU/L T4 TSH fT3 WB/Serum/Plasma 0.40-50.00 pmol/L or 0.26-32.55 pg/mL 2.8-7.1 pmol/L (1.82-4.61 pg/mL) fT4 WB/Serum/Plasma 1.00-100 pmol/L or 0.078-7.77 ng/dL 12-22 pmol/L (0.94-1.72 ng/dL) Thyroid Function Cortisol WB/Serum/Plasma 50-1000 nmol/L 7:00-10:00 a.m.: 201.31-536.54 nmol/L 4:00-8:00 p.m.: 65.78-330.85 nmol/L Others Serum/Plasma 75 μL 10 μL 75 μL 10 μL 75 μL 10 μL 75 μL 75 μL 75 μL 75 μL 75 μL 20 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL 10 μL 100 μL for whole blood 75 μL for plasma/serum 5-100 ng/mL 30-100 ng/mL Vitamin D Reaction Time 5 min 15 min 15 min 15 min 15 min 5 min 3 min 5 min 15 min 10 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 3 min 15 min 15 min 15 min 3 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min 15 min Vitamin CE CE CE IFCC NGSP CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE CE 75 μL 10-1000 ng/mL <225 ng/mL Lp-PLA2 15 min 0123 CE 0123 CE CE CE 15 μL for whole blood 10 μL for plasma 100 μL for whole blood 75 μL for plasma 75 μL for whole blood 50 μL for plasma/serum 8.5 μL for whole blood 5 μL for plasma/serum 75 μL 75 μL 75 μL 75 μL 75 μL 75 μL <0.2 ng/mL S100β WB/Serum/Plasma 0.05-10 ng/mL Craniocerebral Injury Markers 15 min 75 μL 10 μL 3~4000 pg/mL ≤10 pg/mL WB/Serum/Plasma IL-6 15 min 75 μL 0.03-10 ng/mL 0-0.1 ng/mL Category Test Item Speci Specimen Volume men Type Measuring Range Clinical Reference Qualification Reaction Time Category WB/Serum/Plasma WB/Serum/Plasma WB/Serum/Plasma 10 μL 10 μL Qualitative Qualitative Negative Negative SARS-CoV-2 IgM SARS-CoV-2 Antibody 10 min 10 min CE CE 10 μL Qualitative Negative SARS-CoV-2 IgM/IgG 10 min COVID-19 CE
  • 2. FIA METER PLUS Inner Temperature Control APPLICATION TEST PROCEDURE FS-113 Mixing Dropping Sampling Reading Serum or Plasma or Whole blood Buffer 75μL Dropping Laboratory ER ICU Clinics GP Office Ambulance • Dimension: 270*238*146mm • Weight: 2.8 Kg Portable Easy to operate Get results in 3-15 minutes Provide better reaction condition Good correlation with CLIA method Built-in Thermal Printer Real-time auto-printing • Support for external printers • Large Display 8" LCD Touch Screen • Intuitive user interface • Test Channel Multiple testing modes available • Unique quick mode for large number of samples • Test Reagent Room temperature storage • Suitable for whole blood, serum, plasma and urine • Connection • Direct connection to LIS/HIS ID chip inlet • Automatically reading of batch number and calibration information in the ID chip Designed Sampler • Specially-designed sampler for small volume of specimen Convenient Rapid Test Temperature control Reliable Accuracy 3-15min ID CARD