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CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold

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China Lumigenex (Suzhou) Co. Ltd certification
China Lumigenex (Suzhou) Co. Ltd certification
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CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold

CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold
CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold

Large Image :  CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold

Product Details:
Place of Origin: China
Brand Name: Lumigenex
Certification: CE, ISO13485, cFDA
Model Number: C3108-001, C3108-005, C3108-010, C3108-025, C3108-050
Payment & Shipping Terms:
Minimum Order Quantity: 10000 Test
Price: USD0.85/ test
Packaging Details: 25 tests/Box, 1250 tests/CTN; 5 tests/Box, 1000 tests/CTN; or 1 test/box, 735tests/CTN
Delivery Time: 5-7 Working days
Payment Terms: T/T, Western Union,Paypal
Supply Ability: 1000000 Tests/ Day

CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold

Description
Product Name: PocRoc® Malaria P.f/P.v Antigen Rapid Test Kit (Colloidal Gold) Function: Qualitative Detection Of P.falciparum Specific Histidine Rich Protein- II (Pf. HRP-II) And P. Vivax Specific PLDH. Antigens
Method: Colloidal Gold Instrument Classification: Class II
Format: Cassette Specimen: Whole Blood
Test Time: 15 Minutes Storage Temp: 4℃-30℃
Package: 1 Test/ Box, 5 Tests/ Box, 25 Tests/ Box
High Light:

Malaria Antigen Rapid Testing Kit

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Colloidal Gold Pf Pv Antigen Test

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Malaria Pf Pv Rapid Test Kit

CE Approved Malaria P.F/P.V Antigen Rapid Test Kit Colloidal Gold Sensitive Detection Of Malaria Antigen

PocRoc® Malaria P.f/P.v Antigen Rapid Test Kit (Colloidal Gold)

 

Intended Use
The Malaria (P.f/P.v) Antigen Rapid Testing Kit (Colloidal Gold) is intended for the in vitro rapid qualitative detection of P.falciparum specific histidine-rich protein- II (Pf. HRP-II) and P.vivax specific pLDH. antigens in the whole blood sample and the test kit is used to aid in diagnosing of plasmodium infection. This assay provides only a preliminary qualitative test result, the obtained results should be analyzed in combination with other clinical information.
 
Principle of the Test
PocRoc® Malaria P.f/P.v Antigen Rapid Test Kit with colloidal gold labeling. The test Cassette is composed of the following parts: sample pad, conjugate pad, reaction membrane, and absorbing pad. The reaction membrane contains two test lines, the T1 test line is pre-coated with mouse anti-pf monoclonal antibodies and the T2 test line is pre-coated with mouse anti-pv monoclonal antibodies on the nitrocellulose membrane. The conjugate pad contains colloidal gold particles conjugated with another mouse anti-pf and anti-pv mAbs, which can separately bind to P.falciparum specific histidine-rich protein- II (Pf. HRP-II) and P. vivax specific pLDH. antigens. When the sample is applied to the sample well, the P.falciparum specific histidine-rich protein- II (Pf. HRP-II) and P. vivax specific pLDH. antigens in the sample and the labeled anti-pf and anti-pv mAbs complexes are separately formed and travel along the test strip. The complexes are separately captured by the mouse anti-pf and anti-pv mAbs to form colored lines in the test lines. Internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control lines, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, the test result is regarded as invalid and the test should be repeated with a new test kit and specimen.

 

CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold 0CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold 1

 

 

 

 

Specification

 

Product Name
PocRoc® Malaria P.f/P.v Antigen Rapid Test Kit (Colloidal Gold)
Function
Qualitative detection of P.falciparum specific histidine-rich protein- II (Pf. HRP-II) and P. vivax specific pLDH. antigens
Method
Colloidal Gold
Usage
Point-of-care Test Reagent for Hospital usage and home usage
Specimen
Whole blood
Composition of the Test Kit
1.Test device is composed of a plastic cassette and a test strip. The test strip is composed of a sample pad, a conjugate pad, nitrocellulose membrane, an absorbing pad and polyvinyl chloride(PVC) backing card.
2.The sample buffer is composed of PBS buffer, Triton-100 and proclin 300.
* Do not exchange components with different batch numbers.
Storage
All components are ready to use as supplied.
Unopened test kits are stable at 4-30°C for 24 months.
Once the pouch is opened, It must be used in 1h under 20-30°C and humidity below 60%. After the expiration date, the test kit should be discarded as biohazard waste.
 
The Contents of the Test Kit
Ref No.  
Package
Test Cassette
Sample Buffer
Capillary Pipette
IFU
C3108-01-001
1 Test / Box
1
1
1
1
C3108-01-005
5 Tests / Box
5
5
5
1
C3108-01-010 
10 Tests / Box
10
10
10
1
C3108-01-025
25 Tests / Box 25 1 bottle 25 1
C3108-01-050
50 Tests / Box 50 1 bottle 50 1
 

Test Procedure

 

1. Use the capillary pipette provided to add 5μl of fingertip whole blood or Venipuncture whole blood into the sample well(S).

2. Add 100-120μl (about 2 drops) of sample buffer into well (B).

3. Read the test result within 20-30 minutes.

CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold 2

 

 

Certificates

 

CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold 3 CE Approved Malaria P.F P.V Antigen Rapid Test Kit Colloidal Gold 4
 
 

 

Contact Details
Lumigenex (Suzhou) Co. Ltd

Contact Person: Bonnie

Tel: 86-13814877381

Send your inquiry directly to us (0 / 3000)