Malaria P.f Pan P.f P.v Test Kit with CE certificate

Product Description
Malaria P.f/Pan P.f/P.v Rapid Diagnostic Test Kit

Malaria P.f./Pan Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation
of Plasmodium falciparum (Pf) antigen and P. vivax, P. ovale, or P. malariae (Pan) antigen
in human Whole Blood. It provides an aid in the diagnosis of infection with Malaria.



US FDA CLEARANCE, CE MARKING, GOOD WORLDWIDE MARKET


Product Name
Malaria Rapid Diagnostic Test Kit

Specimen
Whole Blood
Sensitivity
Custom
Format
Cassette
Width
4.0mm
Application
Diagnosis of infection with Malaria

Usuage
Professional use only


Characteristic

* High sensitivity and specificity, result in 15 min.

* Safe and Simple to use, easy to read result, easy to carry.
* Single test and suitable for professional use.
Storage
Store in room temperature
Shelf Life
24 months
Certificate
CE/ ISO13485/ ISO9001
Packing
1 test/pouch, 25 tests with one insert per box
Production time
25 days after order /confirm/ied
Delivery
By ship/ Airplane/ Express
Sample
7 days free samples provided
Service
OEM service acceptable
Detailed Images
Principle
Malaria remains one of the most serious tropical and subtropical diseases in many countries of the world. It is rampant in most areas of the tropics. Malaria is caused by a parasite that is transmitted from one person to person by the bite of infected Anopheles mosquitoes. There are four kinds of malaria that can infect humans: P.falciparum, P.vivas, P.malariae, and P.ovale.
Our one step Rapid Malaria P.f/Pan Test Kits utilizes the principle of immunochoromatograhpy. As the test sample flows through the membrane assembly of the device after addition of the buffer, the colored monoclonal P.f specific HRP-2, Pan specific pLDH colloidal gold conjugate antibodies complexes the proteins in the lysed sample. This complex moves further on the membrane to the test region where it is immobilized by the P.f specific HRP-2 antibody/Pan specific pLDH which will lead to a formation of purple color band/s. While both the bands will appear at the test region in falciparum positive samples, only one band would appear in non-falciparum malaria positive sample. Absence of this color band/s in the test region indicates a negative test result.
The unreacted conjugate along with the rabbit globulin colloidal gold conjugate and unbound complex if any, move further on the membrane and are subsequently immobilized by anti-rabbit antibodies coated on the membrane at the control region, forming a pink/purple band. This control band serves to validate the test performance.


Intended Use
Our Malaria P.f/Pan whole blood test cassette is a rapid self-performing, qualitative, two site sandwich immunoassay, utilizing whole blood for the detection of P.falciparum specific histidine rich protein-2(P.f HRP-2) and Pan specific pLDH. The test may also be used for differentiation of P.falciparum and other malarial species in whole blood samples and for the follow up of anti-malarial therapy.

Performance
Table 1: Result of the sensitivity and specificity between(Malaria P.f)
Table 2: Result of the sensitivity and specificity between(Malaria Pan)
P.f Positive sample
(n=123)
P.f Negative sample
(n=202)
Sensitivity
Specificity
Our Rapid Test
118/123
196/202
96.0%
97.0%
Microscopic examination
123/123
202/202
Pan Positive sample
(n=158)
Pan Negative sample
(n=167)
Sensitivity
Specificity
Our Rapid Test
153/158
161/167
96.8%
96.4%
Microscopic examination
158/158
167/167





Test Procedure and Interpretation
For in vitro diagnostic use only. For healthcare professional use only.
Packing & Delivery
Packing:
1) Individual packing, 1 test/pouch.
2) Packed in bulk with Polybag.
3) According to customer's requirements.

Delivery:
1) By Ship/ airplane/ Express according to different quantity.
2) According to customer's requirements.

Certifications

US FDA Clearance, CE Marking, Good Worldwide Market


Our Company
Advantage:

1) Custom manufacturing of quality medical products and biochemical reagents.
2) Obtained ISO 9001 certificate,GMP approval,FDA approval and CE Mark already.
3) More than 30% of the employed staff have obtained master and doctor degree from prestigious worldwide institutions.
4) More than 30,000 square feet of laboratory space.
5) Immunogold Labeling Techniques.
6) Superb quality products with very affordable prices.
7) Provide prompt and effective after-sale service, ensure the customer no any risk on our products.

Our Service
Our company also provide range of service as below:
* Professional sourcing.
* Purchase agent to contract with your chinese suppliers to protect your benefit.
* Quality control.
* Shipping line booking.
* Custom clearance assist.
* Factory tour arrangement when customers visit China.
We have a professional team with many years of Export and import experience.



Related Products
FAQ
We want to give you best price and service, please let us know more details as follows:
1. P.f, P.f/Pan, P.f/P.v
---- Which one you need?


2. Do you need OEM packing?

---- Let us know details about your packing.
3.How many do you want to buy?



4. EXW price or FOB Price or CIF(please give me your destination)?
Thanks for your interested in our products, any question please do feel free to contact us: 86-18917377467 Michi