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Malaria P.F / Pan Diagnostics Cassette Test Plasmodium Falciparum Plasmodium Vivax

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO
Model Number: MAL
Minimum Order Quantity: 10000pcs
Price: $0.3-0.60/pcs
Packaging Details: 25tests/box 20test/box
Delivery Time: 5-20 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 100000pcs/day
Detail Information
Test Parameter: Malaria P.f/Pan Principle: Immunochromatography
Storage: Room Temperature 2-30℃ Main Component: Rapid Test Cassette + Buffer + Dropper + IFU
Sample: Blood Reading Time: In 15 Mins
High Light:

Plasmodium Falciparum Diagnostics Cassette Test

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Immunochromatography Diagnostics Cassette Test

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Plasmodium Vivax Rapid Test Kit


Product Description

Malaria P.f/Pan Rapid Test Kit Plasmodium falciparum , Plasmodium vivax , Plasmodium ovale , Plasmodium malariae

INTENDED USE

The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood.

 

INTRODUCTION

Malaria is caused by a protozoan which invades human red blood cells.1 World Health Organization estimates that 3.3 billion were at risks of acquiring malaria in 2006, with 247 million of these developing clinical malaria (86% in Africa), and nearly 1 million (mostly African children) dying from the disease. 2 Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century.3 The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology. The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P.falciparum-specific HRP-II antigens and/or Pan-malarial Aldolase antigens found in P.falciparum(P.f), P.vivax(P.v), P.ovale(P.o) and P.malariae(P.m). The test utilizes colloid gold conjugate to selectively detect P.f-specific and Pan-malarial antigens (P.f, P.v, P.o and P.m) in whole blood.

 

PRINCIPLE

The Malaria P.f/Pan Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f, P.v, P.o and P.m antigens in whole blood. The membrane is pre-coated with anti-HRP-II antibodies and anti-Aldolase antibodies. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated on the test strip. The mixture then migrates upward on the membrane by capillary action, reacts with anti-Histidine-Rich Protein II (HRP-II) antibodies on the membrane on P.f Test Line region and with anti-Aldolase antibodies on the membrane on Pan Line region. If the specimen contains HRP-II or Plasmodium-specific Aldolase or both, a colored line will appear in P.f line region or Pan line region or two colored lines will appear in P.f line region and Pan line region. The absence of the colored lines in P.f line region or Pan line region indicates that the specimen does not contain HRP-II and/or Plasmodium-specific Aldolase. To serve as a procedure control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

 

MAIN CONTENTS

Rapid Test Cassette in Pouch

Buffer

Disposable dropper

Package insert

 

STORAGE

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).

The test is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

DO NOT FREEZE.

Do not use beyond the expiration date.

 

SAMPLE COLLECTION

1. The Malaria P.f/ Pan Rapid Test Device (Whole Blood) is intended for use with human whole blood specimens only.

2. Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20°C. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 3 days of collection.

3. Containers containing anticoagulants such as EDTA, citrate, or heparin should be used for whole blood storage.

4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.

5. If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.

6. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

 

OPERATION PROCEDURE

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 pipette:

  • To use a Pipette: Transfer 10 mL of whole blood to Well-1 (W1) of the test device, then add 3 full drops of buffer to Well-2 (W2), and start the timer. (See illustration ① below). Avoid trapping air bubbles in W1.
  • To use a Disposable Specimen Pipette: Hold the pipette vertically; draw the specimen up to the Fill Line as shown in illustration ① below. Transfer the specimen to W1 of the test device, then add 3 full drops of buffer to W2 and start the timer. Avoid trapping air bubbles in W1.

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.

 

INTERPRETATION

Malaria P.F / Pan Diagnostics Cassette Test Plasmodium Falciparum Plasmodium Vivax 0

For details, please contact Dewei staff for Instruction Manual!

Malaria P.F / Pan Diagnostics Cassette Test Plasmodium Falciparum Plasmodium Vivax 1

Contact Details
Sherry

Phone Number : +8613316305166

WhatsApp : +008615267039708