Specimen Type

Product Product Buffer Buffer

Test Item Diseases Buffer Mixture Reaction Time Linear Range Clinical Reference
Class Shelf-life Storage Shelf-life Whole Seru Plasm
Blood m a

PCT 24 months 4-30℃ 24 months Sepsis 75 μL 50 μL 50 μL 200 μL 75 μL 15 min 0.1-100 ng/mL 0-0.5 ng/mL

PCT(One Step) 24 months 4-30℃ 24 months Sepsis 100 μL 75 μL 75 μL / / 15 min 0.1-100 ng/mL 0-0.5 ng/mL

CRP CRP: 0-10 mg/L

24 months 4-30℃ 24 months Inflammation 8.5 μL 5 μL 5 μL 500 μL 75 μL 3 min 0.5-200 mg/L

Infection
(hsCRP+CRP) hsCRP: 0-1 mg/L

Inflammation& CRP: 0.5～150 mg/L CRP: ＜10 mg/L

CRP/PCT 12 months 4-30℃ 12 months 75 μL 75 μL 75 μL 380 μL 75 μL 15 min
Sepsis PCT: 0.1～100 ng/mL PCT: ＜0.5 ng/mL

SAA 4-30℃ Infection & Inflammation 10 μL 10 μL 10 μL 400 μL 75 μL 15 min 1.0-300 mg/L 0-10 mg/L

D-Dimer 24 months 4-30℃ 24months Thrombosis 15 μL / 10 μL 200 μL 75 μL 5 min 0.1-10 mg/L 0-0.5 mg/L
Coagulati
on
D-Dimer (One Step) 24 months 4-30℃ / Thrombosis 75 μL / 75 μL / / 5 min 0.1-10 mg/L 0-0.5 mg/L

＜75y, 0-300 ng/L

NT-proBNP 24 months 4-30℃ 24 months Heart Failure 75 μL 75 μL 75 μL 200 μL 75 μL 15 min 18-35000 pg/mL

≥75y, 0-450 ng/L

＜75y, 0-300 ng/L

NT-proBNP (One Step) 24 months 4-30℃ / Heart Failure 100 μL 75μL 75μL / / 15 min 18-35000 pg/mL

≥75y, 0-450 ng/L

BNP 4-30℃ Heart Failure 75 μL / 75 μL 200 μL 75 μL 15 min 5-5000 pg/mL 0-100 pg/mL

cTnI:0.00~0.30 ng/mL
cTnI: 0.1~50 ng/mL NT-ProBNP:
cTnI/NT-ProBNP 4-30℃ Heart Failure 75 μL 75 μL 75 μL 200 μL 75 μL 15 min
NT-ProBNP:18~35000 pg/mL <75 year old：0~300 pg/mL;
≥75 years old：0~450 pg/mL
 cTnI 24 months 4-30℃ 24 months Myocardial Infarction 75 μL 75 μL 75 μL 200 μL 75 μL 15 min 0.1-50 ng/mL 0-0.3 ng/mL

Cardiac cTnI (One Step) 24 months 4-30℃ / Myocardial Infarction 100 μL 75 μL 75 μL / / 15 min 0.1-50 ng/mL 0-0.16 ng/mL

Myo 24 months 4-30℃ 24 months Myocardial Infarction 75 μL 75 μL 75 μL 200 μL 75 μL 15 min 2.0-400 ng/mL 0-58 ng/mL

Myo(One Step) 24 months 4-30℃ / Myocardial Infarction 100 μL 75 μL 75 μL / / 15 min 2.0-400 ng/mL 0-58 ng/mL

CK-MB 24 months 4-30℃ 24 months Myocardial Infarction 75 μL 75 μL 75 μL 200 μL 75 μL 15 min 0.3-100 ng/mL 0-5 ng/mL

CK-MB (One Step) 24 months 4-30℃ / Myocardial Infarction 100 μL 75 μL 75 μL / / 15 min 0.3-100 ng/mL 0-5 ng/mL

H-FABP 24 months 4-30℃ 24 months Myocardial Infarction 75 μL 75 μL 75 μL 200 μL 75 μL 15 min 1-120 ng/mL 0-7 ng/mL

3 in 1 (cTnI/Myo/CK-MB) 4-30℃ 24 months Myocardial Infarction 75 μL 75 μL 75 μL 350 μL 75 μL 15 min Same with single items Same with single items

3 in 1 (cTnI/Myo/CK-MB)
24 months 4-30℃ / Myocardial Infarction 100 μL 75 μL 75 μL / / 15 min Same with single items Same with single items
(One Step)

AFP 24 months 4-30℃ 24 months Liver Cancer / 75 μL 75 μL 200 μL 75 μL 15 min 5-400 ng/mL 0-20 ng/mL

FPSA 24 months 4-30℃ 24 months 75μL 75μL 75μL 300μL 75μL 15min 0.2~30ng/mL 0~1.0ng/mL

PSA 24 months 4-30℃ 24 months Prostate Cancer / 75 μL 75 μL 200 μL 75 μL 15 min 2-100 ng/mL 0-4 ng/mL

Cancer fPSA 4-30℃ Prostate Cancer 75 μL 75 μL 75 μL 300 μL 75 μL 15 min 0.2~30 ng/mL < 1 ng/mL

CEA 24 months 4-30℃ 24 months Colorectal Carcinoma 75 μL 75 μL 75 μL 350 μL 75 μL 15 min 1-500 ng/mL 5ng/ml
Cancer

HbA1c 24 months 4-30℃ 24 months Diabetes Mellitus 10 μL / / 1000 μL 75 μL 5 min 23q4.0-14.5% 0-6.5%

MAU (One Step) 24 months 4-30℃ / Renal Injury Urine 75 μL / / 3 min 5-300 ng/mL 0-20 ng/mL

Cys-C 12 months 4-30℃ 12 months Renal Injury 10 μL 10 μL 10 μL 600 μL 75 μL 5 min 0.2-10 mg/L 0.5-1.1 mg/L

NGAL 4-30℃ Renal Injury Urine 75 μL 750 μL 75 μL 15 min 10-1500 ng/mL ≤131.7 ng/mL
Diabetes
& Renal
Injury Proximal Renal

β2-MG 4-30℃ 10 μL 10 μL 10 μL 250 μL 75 μL 10 min 0.3~20mg/L 1.0～2.7mg/L

Tubule Dysfunction

β-HCG 18 months 4-30℃ 18 months Fertility 20 μL 20 μL 20 μL 300 μL 75 μL 15 min 2-200,000 mIU/mL 5 mIU/mL

0.40~50.00 (0.26~32.55)
Fertility fT3 24 months 4-30℃ 24 months Thyroid Malfunction 75μL 75μL 75μL 100μL 75μL 15min
pmol/L (pg/mL)
2.8~7.1 (1.82~4.61)pmol/L (pg/mL)

1.00~100 (0.078~7.77)pmol/L
fT4 24 months 4-30℃ 24 months Thyroid Malfunction 75μL 75μL 75μL 500μL 75μL 15min 12~22 (0.94~1.72)pmol/L (ng/dL)
(ng/dL)
T3 24 months 4-30℃ 24 months Thyroid Malfunction 75 μL 75 μL 75 μL 100 μL 75 μL 15 min 0.61-9.22 nmol/L 1.3-3.1 nmol/L

T4 24 months 4-30℃ 24 months Thyroid Malfunction 75 μL 75 μL 75 μL 500 μL 75 μL 15 min 12.87-300 nmol/L 66-181 nmol/L

TSH 24 months 4-30℃ 24 months Thyroid Malfunction 75 μL 75 μL 75 μL 200 μL 75 μL 15 min 0.1-100 mIU/L 0.3-4.2 mIU/L

Male 1.50~12.40
Follicular period 4.46~12.43
FSH 24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 380ul 75 μL 15 min 1 -100 mIU/mL Ovulation period 4.88~20.96
Luteal phase 1.96~7.70
Menopause phase 22.70~130.00

Male——
20-60 years old: 0.92~13.89ng/mL Female——
AMH 24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 100μL 75μL 15min 0.1~16ng/mL 20-29 years old: 0.88~10.35ng/mL 30-39 years
old: 0.31~7.86ng/mL 40-50 years old:
≤5.07ng/mL

Male 1.70~8.60
Follicular period 2.95~13.65
LH 24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 380ul 75 μL 15 min 1 -100 mIU/mL Ovulation period 13.65~95.75
Luteal period 1.25~11.00
Menopause period 8.24~55.23

Hormone
 Male 3.45~17.42
PRL 24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 1000 μL 75 μL 15 min 1 ~200 ng/mL
Female (non-pregnant) 4.60~25.07
Hormone
Male 38.0±13.0
Follicular Phase 0.2-2.0
Ovulatory Phase 0.7-3.5
PROG 24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 150ul 75 μL 15 min 1.5~60 ng/mL Luteal Phase 3.0-30.0
Postmenopausal 0.1-0.9
7th Week of Pregnancy
Male <85 4.5±7.6
9-12th Week ofperiod
Follicular Pregnancy
12.4 -38.0±13.0
262
Ovulation period 101 - 396
E2 24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 100μL 75 μL 15 min 9~3000 pg/Ml
Luteal phase 95 - 381
Menopause phase <190
Pregnancy 145 - >3000

Testosterone Male 1.61～8.41 ng/mL

24 months 4-30℃ 24 months Sex hormone 75 μL 75 μL 75 μL 150μL 75 μL 15 min 0.2~15 ng/mL
Female ＜0.61 ng/mL

Dissociation agent <20 Deficiency

24 months, A 2.5 ML
Reconstitution : A+B： 20-30 Insufficiency
VD 2-8℃ 12 months Bone metabolism / 75 μL 75 μL B 2.5 ML 75 μL 5~100 ng/mL
10min Dissociation agentC： 30-100 Sufficiency
2-8℃ for 28 days C 4.5 ML
5min Reaction: 15min >100 Toxicity

7:00 ~ 10:00 a.m.: 201.31～536.54

Cortisol 24 months 4-30℃ 24 months Adrenal dysfunction 75 μL 75 μL 75 μL 750ul 75 μL 15 min 50~ 1000 nmol/L 4:00 ~ 8:00 p.m.: 65.78～330.85
 Whole blood
Qualification CV Traceability brand Anticoagulant
Coefficient

1.0
CE CFDA CV≤15% Peripheral blood/S/P: ROCHE EDTA, Heparin, Sodium Citrate
0.65

CE CV≤15% / VIDAS® B•R•A•H•M•S PCT EDTA, heparin or sodium citrate

CV≤15% 1

CE CFDA ROCHE EDTA, Heparin, Sodium Citrate

CV≤15%

CRP：ROCHE
CE CV≤15% 1.4 EDTA, Heparin, Sodium Citrate
PCT：ROCHE

CE CV≤15% 1.4 Siemens EDTA, Heparin, Sodium Citrate

CE CFDA CV≤15% 1 Siemens EDTA, Heparin, Sodium Citrate

CE CV≤15% / SYSMEX EDTA-k2

CE CFDA CV≤15% 1.3 Roche EDTA

CE unknown / Roche EDTA

CE CV≤15% 1.5 Alere EDTA

cTnI:1.0 cTnI：Backman
CE CV≤15% EDTA
NT-proBNP:1.3 NT-proBNP：Roche
 Intra-Lot 0.3, CV≤10%
CE CFDA 1 Roche EDTA
Inter-Lot 0.3,CV≤15%

CE unknown / Roche EDTA

CE CFDA CV≤15% 1 Backman EDTA

CE CV≤15% / Backman EDTA

CE CFDA CV≤15% 1 Backman EDTA

CE unknown / Backman EDTA

CE CFDA CV≤15% 1.5 Roche EDTA, Heparin, Sodium Citrate

cTnI:1.0
/ CV≤15% CK-MB:1.0 Backman EDTA
Myo:1.0

CE CFDA unknown / x EDTA

CE CFDA CV≤10% 1.75 Roche EDTA, Heparin, Sodium Citrate

EDTA, Heparin and Sodium

CE CV≤15% 1.5 Roche FPSA reagent kit
Citrate

CE CFDA CV≤15% 1.7 Boditech Med Inc EDTA, Heparin, Sodium Citrate

/ CV≤15% 1.5 ROCHE EDTA, Heparin, Sodium Citrate

/ CV≤15% 1.5 ROCHE EDTA, Heparin, Sodium Citrate

CE CFDA NGSP Intra-Lot 8%, CV≤6%
1 Bio-Rad HPLC EDTA,
IFCC Inter-Lot 8%,,CV≤10%

CE CFDA CV≤15% —— Orion ——

CE CV≤15% 1.5 Hitachi biochemical analyzer EDTA

CE CV≤15% 1 ABBOT NGAL Reagent Kit ——

CE CV≤15% 1.41 SIMENS EDTA

CE CV≤15% 1.5 Roche β-hCG Reagent Kit EDTA, Heparin, Sodium Citrate

Intra-Lot, CV≤15%
/ 1.5 Roche fT3 Reagent Kit EDTA, Heparin, Sodium Citrate
Inter-Lot,CV≤20%

/ CV≤15% 1.5 Roche fT4 Reagent Kit EDTA, Heparin, Sodium Citrate
CE CV≤15% 1.5 Roche T3 Reagent Kit EDTA, Heparin, Sodium Citrate

CE CV≤15% 1.5 Roche T4 Reagent Kit EDTA, Heparin, Sodium Citrate

CE CV≤15% 1.25 Roche TSH Reagent Kit EDTA, Heparin, Sodium Citrate

CE CV≤15% 1.6 Roche Elecsys® FSH test EDTA

Intra-Lot , CV≤10%
/ 1.55 Roche EDTA
Inter-Lot ,CV≤15%

CE CV≤15% 1.3 Roche Elecsys® EDTA

/ CV≤15% 1.5 Roche Elecsys® PRL test EDTA

Roche Elecsys® Progesterone II

CE CV≤15% 1.67 Sodium Citrate
Immunoassay on Cobas e Analyzers

EDTA, lithium heparin and orsodium

/ CV≤15% 1.2 Roche Elecsys®
citrate

/ CV≤15% 1.7 Roche Elecsys® EDTA

Heparin，lithium heparin or sodium

/ CV≤15% 1 Roche Cobas
citrate

/ CV≤15% 1.6 Roche reagent kit EDTA