Calprotectin Rapid Test

• Classification: Poct Analyzer
• Type: Poct Analyzer
• Certification: CE, ISO13485
• Group: Male and Female
• Medical Device Regulatory Type: Type 1
• Medical Devices Ad. Approval No.: Sdaa-20123609562
• Model NO.: CAL-W23
• Medical Devices Reg./Record No.: Sxzz-20152401060
• Transport Package: Box and Carton
• Specification: Customized Package
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 1000000 Piece

Product Description

Calprotectin rapid test

For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
INTENDED USE
Diagnostic Kit for Calprotectin(cal) is is a colloidal gold immunochromatographic assay for the semiquantitative determination of cal from human faeces, which has important accessory diagnostic value for inflammatory bowel disease. This test is a screening reagent. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only. Meanwhile, this test is used for IVD, extra instruments are not needed.
SUMMARY
Cal is a heterodimer, which is composed of MRP 8 and MRP 14. It exists in neutrophils cytoplasm and expressed on mononuclear cell membranes. Cal is acute phase proteins, it has a well stable phase about one week in human faeces, it is determined to be a inflammatory bowel disease marker. The kit is a simple, visual semiqualitative test that detects cal in human faeces, it has high detection sensitivity and strong specificity. The test based on high specificit double antibodies sandwich reaction principle and gold immunochromatographic assay analysis technics, it can give a result within 15 minutes.
PRINCIPLE OF THE PROCEDURE
The strip has anti cal coating McAb on test region and goat anti-rabbit IgG antibody on control region, which is fastened to membrane chromatography in advance. Lable pad is coated by colloidal gold labeled anti cal McAb and colloidal gold labeled rabbit IgG antibody in advance. When testing positive sample, the cal in sample comined with colloidal gold labeled anti cal McAb, and form immune complex, as it is allowed to migrate along the test strip, the cal conjugate complex is captured by anti cal coating McAb on the membrane and form "anti cal coating McAb-cal-colloidal gold labeled anti cal McAb" complex, a colored test band appeared on test region. The color intensity is positively correlated with the cal content. A negative sample does not produce a test band due to the absence of colloidal gold conjugate cal complex. No matter cal is present in sample or not, there is a red stripe appear on reference region and quality control region, which is regarded as quality internal enterprise standards.
REAGENTS AND MATERIALS SUPPLIED
25T package components:

• Test card individually foil pouched with a desiccant
• Sample diluents: the ingredients is 20mM pH7.4PBS
• Dispette
• Package insert

Immunofluorescence quantitative analysis series

Catogory	Product Name	Abbreviation	MOQ.
Gastrointestinal tract	Diagnostic Kit for Calprotectin	Cal	1000
	Diagnostic Kit for Fecal Occult Blood	FOB	1000
	Diagnostic Kit for Pepsinogen I/Pepsinogen II	PGI/PGII	1000
	Diagnostic Kit for Antigen to Helicobacter Pylori	HP-Ag	1000
	Diagnostic Kit for Antibody to Helicobacter Pylori	HP-Ab	1000
	Diagnostic Kit for Gastrin-17	G-17	1000
Inflammation	Diagnostic Kit for C-reactive protein	CRP	1000
	Diagnostic Kit for Procalcitonin	PCT	1000
	Diagnostic Kit for hypersensitive C-reactive protein	Hs-CRP	10000
Kidney	Diagnostic Kit for Microalbuminuria	ALB	1000
Heart series	Diagnostic Kit for Cardiac Troponin I	cTnI	1000
	Diagnostic Kit for D-Dimer	D-Dimer	10000
	Diagnostic Kit for Pro-brain natriuretic peptide to amino-terminal	NT-proBNP	1000
	Diagnostic Kit for Isoenzyme MB of Creatine Kinase	CK-MB	10000
	Diagnostic Kit for Cardiac Troponin I,MYO,Isoenzyme MB of Creatine Kinase	cTnI, MYO, CK-MB	10000
Hormone series	Diagnostic Kit for Luteinizing Hormone	LH	10000
	Diagnostic Kit for Human Chorionic Gonadotropin	HCG	10000
	Diagnostic Kit for Follicle Stimulating Hormone	FSH	10000
	Diagnostic Kit for Estradiol	E2	10000
	Diagnostic Kit for Progesterone	Prog	10000
	Diagnostic Kit for Testosterone	Tes	10000
	Diagnostic Kit for adrenal medullary hormone	AMH	1000
	Diagnostic Kit for Pituitary Prolactin	PRL	1000
	Diagnostic Kit for Cortisol	Cor	10000
Thyroid function	Diagnostic Kit for Total Triiodothyronine	T3	10000
	Diagnostic Kit for Total Thyroxine	T4	10000
	Diagnostic Kit for Thyroid Stimulating Hormone	TSH	10000
Tumor marker	Diagnostic Kit for Alpha-fetoprotein	AFP	10000
	Diagnostic Kit for Carcino-embryonic Antigen	CEA	10000
	Diagnostic Kit for Prostate Specific Antigen	PSA	10000
	Diagnostic Kit for free Prostate Specific Antigen	f-PSA	1000
Else	Diagnostic Kit for Glycosylated Hemoglobin A1c	HbA1C	1000
	Diagnostic Kit for Ferritin	FER	1000
	Diagnostic Kit for 25-hydroxy Vitamin D	25-(OH) VD	1000
Infectious disease	Diagnostic Kit for Hepatitis C virus antibody	HCV	1000
	Portable Immune Analyzer	A101

Colloidal gold and latex series

Product Name	Abbreviation	MOQ.
Diagnostic Kit for Dengue NS1 antigen (Colloidal gold)	Dengue NS	20000
Diagnostic Kit for IgM/IgG Antibody to Dengue (Colloidal Gold)	Dengue IgM/IgG	20000
Diagnostic Kit for Hepatitis C virus antibody (Colloidal Gold)	HCV	20000
Diagnostic Kit for p24 antigen of Human immunodeficiency virus (Colloidal Gold)	p24	20000
Diagnostic Kit for Rotavirus Group A and Adenovirus (Latex)	RV-AV	1000
Diagnostic Kit for IgM Antibody to Chlamydia Pneumoniae (Colloidal Gold)	Cpn-IgM	1000
Diagnostic Kit for IgM Antibody to Mycoplasma Pneumoniae (Colloidal Gold)	MP-IgM	1000
Diagnostic Kit for IgM Antibody to Human Enterovirus 71 (Colloidal Gold)	EV-71	1000
Diagnostic Kit for Rotavirus Group A (Latex)	RV	1000
Diagnostic Kit for Adenovirus (Latex)	AV	1000
Diagnostic Kit for Antibody to Helicobacter Pylori (Colloidal gold)	HP-Ab	1000
Diagnostic Kit for Antigen to Helicobacter Pylori (Latex)	HP-Ag	1000
Diagnostic Kit (Colloidal Gold) for Microalbuminuria	Alb	1000
Diagnostic Kit (Colloidal Gold) for Fecal Occult Blood	FOB	10000
Diagnostic Kit (Colloidal Gold) for Transferrin	Tf	1000
Diagnostic Kit (Colloidal Gold) for Calprotectin	Cal	1000

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