Audited Supplier
MALP-DW02
IVD Reagent
Rapid Test + Buffer + Pipettes
Whole Blood
Within 15 Mins
2~30 º C
Immunochromatography
24 Months
CE
Professional Used
Dewei
40tests/Box
1000tests/carton
China
Product Description
INTENDED USE
This Malaria P.f/P.v Rapid Test Kit is a rapid test for the qualitative detection of Malaria Antigen P.f or/and P.v in human venous and capillary whole blood.
For professional use only.
INTRODUCTION
This Malaria Antigen P.f/P.v Rapid Test Kit is a lateral flow immunochromatographic assays for qualitatively detection of Malaria Antigen P.f or/and P.v in human venous and capillary whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a p.v-malarial antigen, common to P. vivax (P.v.).It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from P. vivax (P.v.) infections.
PRINCIPLE
This Malaria Antigen P.f/P.v Test is based on the principle of sandwich immunoassay for detection of Malaria Antigen P.f and P.v Monoclonal antibodies are employed to identify Malaria Antigen specifically.
The histidine-rich protein II (HRPII) monoclonal antibody (Pf), P.v specific pLDH monoclonal antibody (Pv) and IgG polyclonal antibody (Control Line) are used as the solid of the assay. The monoclonal antibody can bind with the Malaria Antigen P.f or/and P.v in the whole blood specimen.
During the test procedures, the Malaria Antigen P.f in the whole blood specimen will bind with the colloidal gold- HRPII monoclonal antibody specifically, or/and the Malaria Antigen P.v will bind with the colloidal gold- pLDH monoclonal antibody specifically. Because of capillary and chromatographic effects of the Nitrocellulose membrane, the complexes migrate along the membrane to the antibody line (Pf,Pv), form Abα-Ag-Abβ-Au complexes and remain captured in the T line. As a result a red colored band develops in Pf or/and/Pv and the result is positive. If there is no Malaria Antigen in the whole blood specimen, there is no red band in the Test zone, indicating negative result. No matter if there's Malaria Antigen P.f/P.v in the whole blood specimen, when the complexes migrate along the Control zone, a red band must be developed in the C zone.
To serve as a procedure control, a colored line will appear at the Control Region (C), of each strip, if the test has been performed properly.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
INTERPRETATION OF RESULTS
Positive (+)
Malaria P.f Positive: Both Pf test region (Pf) and control region appear color line.
Malaria P.v Positive: Both Pv test region (Pv) and control region appear color line.
Malaria P.f and P.v Positive: Both test region (Pf and Pv) and control region appear color line.
Negative (-)
Only one colored band appears, in the control region (C). No colored band appears in the test region (Pf and Pv).
Invalid
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
For professional use only.
| Storage | 2~30 º C |
| Specimen | Whole Blood |
| Component | Rapid Test + Buffer + Pipettes |
| Principle | Colloidal gold rapid tests |
| Reading | Within 15mins |
| Package | 40tests/box |
| Trademark | Dewei |
| Origin | China |
INTRODUCTION
This Malaria Antigen P.f/P.v Rapid Test Kit is a lateral flow immunochromatographic assays for qualitatively detection of Malaria Antigen P.f or/and P.v in human venous and capillary whole blood of individuals with signs and symptoms of malarial infection. The test targets the histidine-rich protein II (HRPII) antigen specific to Plasmodium falciparum (P.f.) and a p.v-malarial antigen, common to P. vivax (P.v.).It is intended to aid in the rapid diagnosis of human malaria infections and to aid in the differential diagnosis of Plasmodium falciparum (P.f.) infections from P. vivax (P.v.) infections.
PRINCIPLE
This Malaria Antigen P.f/P.v Test is based on the principle of sandwich immunoassay for detection of Malaria Antigen P.f and P.v Monoclonal antibodies are employed to identify Malaria Antigen specifically.
The histidine-rich protein II (HRPII) monoclonal antibody (Pf), P.v specific pLDH monoclonal antibody (Pv) and IgG polyclonal antibody (Control Line) are used as the solid of the assay. The monoclonal antibody can bind with the Malaria Antigen P.f or/and P.v in the whole blood specimen.
During the test procedures, the Malaria Antigen P.f in the whole blood specimen will bind with the colloidal gold- HRPII monoclonal antibody specifically, or/and the Malaria Antigen P.v will bind with the colloidal gold- pLDH monoclonal antibody specifically. Because of capillary and chromatographic effects of the Nitrocellulose membrane, the complexes migrate along the membrane to the antibody line (Pf,Pv), form Abα-Ag-Abβ-Au complexes and remain captured in the T line. As a result a red colored band develops in Pf or/and/Pv and the result is positive. If there is no Malaria Antigen in the whole blood specimen, there is no red band in the Test zone, indicating negative result. No matter if there's Malaria Antigen P.f/P.v in the whole blood specimen, when the complexes migrate along the Control zone, a red band must be developed in the C zone.
To serve as a procedure control, a colored line will appear at the Control Region (C), of each strip, if the test has been performed properly.
WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.
STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
OPERATION
Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a disposable specimen pipette:
1) To use a Pipette: Transfer 5 mL of whole blood to Well-S (S) of the test device, then add 3~4 full drops of buffer to Well-B (B), and start the timer. (See illustration below). Avoid trapping air bubbles in S.
2) To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration below. Transfer the specimen to S of the test device, then add 3~4 full drops of buffer to B and start the timer. Avoid trapping air bubbles in S.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
2. Place the test device on a clean and level surface. Transfer the specimen by a pipette or a disposable specimen pipette:
1) To use a Pipette: Transfer 5 mL of whole blood to Well-S (S) of the test device, then add 3~4 full drops of buffer to Well-B (B), and start the timer. (See illustration below). Avoid trapping air bubbles in S.
2) To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration below. Transfer the specimen to S of the test device, then add 3~4 full drops of buffer to B and start the timer. Avoid trapping air bubbles in S.
3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
Positive (+)
Malaria P.f Positive: Both Pf test region (Pf) and control region appear color line.
Malaria P.v Positive: Both Pv test region (Pv) and control region appear color line.
Malaria P.f and P.v Positive: Both test region (Pf and Pv) and control region appear color line.
Negative (-)
Only one colored band appears, in the control region (C). No colored band appears in the test region (Pf and Pv).
Invalid
Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
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