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ST2 High Accurate FIA Rapid Quantitative Test Kit POCT 20T Assay

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ST2 High Accurate FIA Rapid Quantitative Test Kit POCT 20T Assay

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Brand Name :	WWHS
Model Number :	ST2
Certification :	ISO 13485, CE
Price :	Negotiable
Payment Terms :	L/C, T/T
Supply Ability :	20000 Kits per Week
Delivery Time :	7 Days

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ST2 High Accurate FIA Rapid Quantitative Test Kit POCT 20T Assay

【Product name】 ST2.pdf

Diagnostic Kit for growth STimulation expressed gene 2(Immunochromatographic assay)

【Test principle】

The ST2 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of ST2. The ST2 antigen in the sample was first bound with the conjugated compound of fluorescent labeled ST2 monoclonal antibody, then moved and combined with another ST2 monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.

【Reference interval】

Healthy non-pregnant adults are expected to have serum ST2 values below 35.00ng/mL. It is strongly recommended that each laboratory should determine its own normal and abnormal values based on population.

【Performance】

1. Limits of detection

No more than 10.00ng/mL.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (10.00~ 400.00ng/mL), the linear correlation coefficient R≥0.990.

WWHS Assay list
Cardiac
cat#.	Product item	Specimen	Reaction Time	Measure Range	Clinical Range	Itended Use
1	cTnI	WB/Serum/Plasma	12min.	0.1-40ng/ml	<0.3ng/ml	several heart diseases including myocardial infarction and heart failure.
2	Myo	WB/Serum/Plasma	12min.	5-400ng/ml	<58ng/ml	acute myocardial infarction (AMI) in early stage.
3	CK-MB	WB/Serum/Plasma	12min.	1-200ng/ml	<5ng/ml	acute myocardial infarction (AMI) in early stage.
4	NT-proBNP	WB/Serum/Plasma	10min.	20-35000pg/ml	Under 75:0~347pg/mL, Over 75:0~449pg/mL	heart failure .
5	D-Dimer	WB/Plasma	10min.	40-10000ng/ml	<500ng/ml	disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.
6	cTnI+Myo+CKMB	WB/Serum/Plasma	12min.	same with single item	same with single item	Triple marker of myocardial infarction.
7	ST2	WB/Serum/Plasma	10min.	10-400ng/ml	<35ng/ml	heart failure .
8	Lp-PLA2	WB/Serum/Plasma	10min.	10-900ng/ml	<175ng/ml	Risk evaluation of ACS and atherosclerotic ischemic stroke patients.
9	S100-β	WB/Serum/Plasma	10min.	0.05-10ng/ml	<0.2ng/ml	Cerebral infarction, cerebral injury.
Inflammation
10	CRP / hs-CRP	WB/Serum/Plasma	3min.	0.5-200mg/L	CRP<10mg/L,hs-CRP<1mg/L	nonspecficity inflammatory marker.
11	SAA	Serum	5min.	1-200mg/L	<10mg/L	inflammation&infection.
12	PCT	WB/Serum/Plasma	10min.	0.2-100ng/ml	<0.5ng/ml	Sepsis
13	CRP+SAA	WB/Serum/Plasma	5min.	same with single item	same with single item	inflammation&infection.
14	IL-6	WB/Serum/Plasma	10min.	5-4000pg/ml	10pg/ml	diabetes,rheumatoid arthritis,etc
Thyroid Hormone
15	TSH	Serum/Plasma	15min.	0.3-100mU/L	0.35-5mU/L	hyperthyroidism and hypothyroidism
16	TT3	Serum/Plasma	15min.	0.5-10nmol/L	1.3-3.1nmol/L	thyroid dysfunction
17	TT4	Serum/Plasma	15min.	5-300nmol/L	66-181nmol/L	thyroid dysfunction
18	FT3	Serum/Plasma	15min.	1-100pmol/L	4-10pmol/L	thyroid dysfunction
19	FT4	Serum/Plasma	15min.	5-300pmol/L	19-39pmol/L	thyroid dysfunction
Tumor Marker
20	AFP	Serum/Plasma	15min.	2.5-200ng/ml	<20ng/ml	pregnancy cancer
21	CEA	Serum/Plasma	15min.	1-200ng/ml	<5ng/ml	colon cancer, colorectal cancer,etc.
22	NSE	Serum/Plasma	15min.	1-400ng/ml	<16ng/ml	non-small cell lung cancer
23	FOB	fecal specimens	10min.	50-1000ng/ml	<100ng/ml	Abnormal recessive gastrointestinal bleeding
24	PG II	Serum/Plasma	15min.	1-100ug/L	PGI/PGII>3.0	gastric abnormalities
25	PG I	Serum/Plasma	15min.	2.5-200ug/L	>70ng/ml	gastric abnormalities
26	TPSA	Serum/Plasma	15min.	0.5-40ng/ml	<4ng/ml	prostate cancer
27	FPSA	Serum/Plasma	15min.	0.1-10ng/ml	<1ng/ml	prostate cancer
28	CA12-5	Serum/Plasma	15min.	20-500U/ml	<35U/ml	ovarian cancer
29	CA15-3	Serum/Plasma	15min.	10-400U/ml	< 25 U/mL	breast cancer
30	HE4	Serum/Plasma	15min.	50-2000pmol/L	<140 pmol/L	ovarian cancer
31	CA19-9	Serum/Plasma	15min.	10-400U/ml	< 27 U/mL	pancreatic cancer
32	β-HCG	Serum/Plasma	15min.	5-400mIU/ml	<10 mIU/mL	Early pregrancy, ectopic HCG cancer,incomplete abortion
33	CK19(Cyfra21-1)	Serum/Plasma	15min.	0.5-50ng/ml	<2.5ng/ml	non-small cell lung cancer
Fertility
34	HCG / β-HCG	Serum/Plasma	10min.	5-20000mIU/ml	<5 mIU/mL	early pregrancy.
35	AMH	Serum/Plasma	10min.	0.1-16ng/ml	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	ovarian reserve level
Gastrointestinal
36	FOB	fecal specimens	10min.	qualitative	qualitative	gastrointestinal hemorrhage.
37	TRF	fecal specimens	10min.	qualitative	qualitative	gastrointestinal hemorrhage.
38	FOB+TRF	fecal specimens	10min.	qualitative	qualitative	gastrointestinal hemorrhage.
Infection
39	C.Pneumonia	WB/Serum/Plasma	15min.	qualitative	qualitative	CP infection
40	M.Pneumonia	WB/Serum/Plasma	15min.	qualitative	qualitative	MP infection
41	Covid-19 Antigen	nasal swab, throat swab or nasal wash/aspirate specimens	15min.	qualitative	qualitative	respiratory tract
42	Covid-19 Ab IgG/IgM	WB/Serum/Plasma	15min.	qualitative	qualitative	respiratory tract
43	FluA	nasal swab, throat swab or nasal wash/aspirate specimens	15min.	qualitative	qualitative	respiratory tract
44	FluB	nasal swab, throat swab or nasal wash/aspirate specimens	15min.	qualitative	qualitative	respiratory tract
Renal Injury
45	CysC	WB/Serum/Plasma	5min.	0.4-9mg/L	0.5-1.1mg/L	renal function
46	NGAL	Urine	10min.	10-1500ng/mL	<132ng/mL	acute kidney injury.
Other
47	FERR	Serum	5min.	10-500ng/ml	Male:24ng/mL~335ng/mL, Female:11ng/mL~307ng/mL	iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia
48	HbA1c	WB	10min.	4%-14%	4%-6%	diabetes
49	VD	Serum/Plasma	15min.	8-70ng/mL	19-57ng/mL	fetation

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