Quality Guaranteed Uncut Sheet of Malaria P. F/PV Rapid Test Kit with CE Marked

• Customization: Available
• Type: IVD Reagent
• Certification: CE, ISO13485
• Model NO.: S01-MA-1
• Product Type: Ivd Semi-Finish Material Uncut Sheet
• Delivery Time: 7-15 Workdays
• Method: Colloidal Gold Rapid Test
• Transport Package: Plastic Bag, Sealed Carton
• Specification: 300*60mm, 300*80mm Customized
• Trademark: Sekbio/OEM
• Origin: Shenzhen
• HS Code: 3002150090
• Production Capacity: 1000000

Product Description

 

Product Description

Malaria antigen detection kit is designed as a simple, rapid, qualitative and cost effective method for the simultaneous detection and differentiation of Plasmodium falciparum (P.f) and Plasmodium vivax (P.v) in human whole blood or fingertip whole blood. This device is intended to be used as a screening test and used for the auxiliary diagnosis of P. f and P.v infection.
The Malaria antigen test kit (Lateral chromatography) is based on the principle of microsphere double antibody sandwich method to rapid qualitative determination of P.f/ P.v antigen in human whole blood or fingertip whole blood. The microsphere is marked in anti-HRP-2 antibody (specific to P.f) on the T1 band and anti-PLDH antibody(specific to P.v) on the T2 band, and anti-mouse IgG polyclonal antibody is coated on quality control area (C). When the sample contains malaria HRP2 or pLDH antigen and the concentration is higher than the minimum detection limit, which are allowed to react with the colloidal microsphere coated with Mal-antibody to form antibody-antigen complex. The complex then moves laterally on the membrane and respectively binds to the antibody immobilized on the membrane producing a pink line on the test region, which indicates a positive result. The presence of the control line demonstrates the test has been performed correctly regardless the presence of P.f/ P.v antigen.

Result Interpretation

1.P.f Positive
The presence of two colored bands ("T1" and "C") within the result window indicates P.f Positive.
2.P.v Positive
The presence of two colored bands ("T2"and "C") within the result window indicates P.v.
3.Positive. P.f and P.v Positive
The presence of three colored bands ("T1","T2"and "C") within the result window may indicates mixed infection of P. f and Pan.
4.Negative Result
The presence of only control line(C) within the result window indicates a negative result.
5.Invalid Result
If no band appears in the control region(C), the test results are invalid regardless of the presence or absence of line in the test region(T). The direction may not have been followed correctly or the test may have deteriorated It is recommended that repeat the test using a new device.

NOTE:
The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failure.

 

Detailed Photos

 

Product lists

Uncut Sheet of Rapid test Kit-Colloidal gold
Chlamydia	C. pneumoniae	H. Pylori	Malaria
Rotavirus	Adenovirus	Rota/Adeno	Strep A
Syphilis	HBsAg	HBsAb	HBsAg and HCV
HBsAg /HCV /HIV /Syphilis	Dengue IgG/IgM	Dengue Ns1	Dengue IgG/IgM /NS1
Chikungunya	Cholera	Typhoid	Tuberculosis
HIV1+2	HIV1+2 Ag/Ab	HAV	ToRCH
HCV	HSV	RSV	TOXO
Rubella	CMV	Norovirus	Leishmania
Filariasis	Leptospira	Monkeypox	M.Pneumoniae
Chagas	Brucella	HPV	nCoV
Influenza A+B	Influenza A+B/ nCoV	Influenza A+B/nCoV/RSV	FOB
HCG	LH	IGFBP-1	fFN
AMH	AMH/FSH	MxA	cTnI
25-OH VD	The Customized cut -off and size are available

 

Uncut Sheet of Lateral Flow Quantitive Test Kit
Class	Rapid Test	Sample type	Detection Range
Cardiac Marker	cTn I	Serum/Plasma/Whole blood	0.1~40 ng/mL
	NT-proBNP	Serum/Plasma/Whole blood	100~20000 pg/mL
	CK-MB	Serum/Plasma/Whole blood	1ng/mL~100ng/mL
	BNP	Plasma/Whole blood	5pg/mL~5000pg/mL
	cTnT	Serum/Plasma/Whole blood	30pg/mL~25000pg/mL
	Myo	Serum/Plasma/Whole blood	5ng/mL~500ng/mL
	cTnl/ Myo/ CK-MB	Serum/Plasma/Whole blood	cTnI: 0.1ng/mL~40ng/mL;Myo: 5ng/mL~500ng/mL;CK-MB: 1ng/mL~100ng/mL
	D-Dimer/ cTnI/ NT-proBNP	Serum/Plasma/Whole blood	Dimer: 0.1mg/L~10mg/L; cTnI: 0.1ng/mL~40ng/mL; NT-proBNP: 100pg/mL~20000pg/mL
Inflammatory	PCT	Serum/Plasma/Whole blood	0.1~100 pg/mL
	CRP	Serum/Plasma/Whole blood	0.5~200mg/L
	SAA	Serum/Plasma/Whole blood	5~300mg/L
	IL-6	Serum/Plasma/Whole blood	5~5000 pg/mL
	PCT/ IL-6	Serum/Plasma/Whole blood	PCT: 0.1ng/mL~100ng/mL;IL-6:10pg/mL~10000pg/mL
	CRP/ SAA	Serum/Plasma/Whole blood	CRP 0.5mg/L~200mg/L;SAA 5mg/L~300mg/L,
Glycated hemoglobin	HbA1c	Whole blood	3~14%
Tumor	PSA	Serum/Plasma/Whole blood	2~80 ng/mL
HCG	HCG	Serum/Plasma/Whole blood	5~200000mIU/mL
Anticoagulation	D-Dimer	Plasma/Whole blood	0.1~10 mg/L
Endocrine	TSH	Serum/Plasma/Whole blood	0.1mIU/L ~100.0mIU/L
	T3	Serum/Plasma/Whole blood	0.61~9.22 nmol/L
	T4	Serum/Plasma/Whole blood	12.87~310 nmol/L
	FT3	Serum/Plasma/Whole blood	0.60pmol/L ~45.00pmol/L
	FT4	Serum/Plasma/Whole blood	1.00pmol/L ~100.00pmol/L
	AMH	Serum/Plasma/Whole blood	0.1~16 ng/mL
	PROG	Serum/Plasma	0.35ng/mL~60ng/mL
	PRL	Serum/Plasma/Whole blood	1 ng/mL~200ng/mL
	FSH	Serum/Plasma/Whole blood	1mIU/mL~100 mIU/mL
	LH	Serum/Plasma/Whole blood	1 ~100 mIU/mL
	TES	Serum/Plasma	0.2~15  ng/mL
	E2	Serum/Plasma/Whole blood	15 pg/mL~3000pg/mL
Bone	25-OH-VD	Serum/Plasma/Whole blood	5.0ng/mL~100.0ng/mL
The Customized cut -off and size are available

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