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Malaria Rapid Test Kits

Malaria pf/pv antibody and antigen rapid test kits are used as an aid in the diagnosis of malaria infection.

Malaria pf/pv antibody Test Kits

Intended Use

Malaria rapid diagnostic test kits, including Malaria Pf/Pv antigen test kit, Malaria Pf/Pv antibody test kit and Malaria Pf/Pan antigen test kit, are all blood test kits based on the principle of immune-chromatographic assay, which are widely used to qualitatively detect the malaria antibodies or antigens in human serum or whole blood, as an aid in the diagnosis of malaria infection, or in the monitoring of the malaria prognosis treatment.

Suitable for POCT Use

All the malaria test kits takes about of 15–20 minutes to get the assay result, and the results are read visually by observing the presence or absence of colored lines on the membrane of the test strip, so they are suitable to be used in the POCT setting as a quick screening method.

Malaria Fever

Malaria fever is a serious, sometimes fatal, parasitic disease characterized by fever, chills, and anemia and is caused by a parasite that is transmitted from one human to another by the bite of Anopheles mosquitoes. Four kinds of malaria can infect humans: Plasmodium falciparum, P. vivax., P. ovale and P. malaria.

WHO emphasized the urgent need for simple and cost-effective diagnostic testing method for malaria, to overcome the deficiencies of both light microscopy and clinical diagnosis. Malaria immunoassay test devices are ideal testing devices that meet this requirements.

Malaria Virus Test Kits: Principle, Packing...

Cat. No. Description (& Details) Specimen PCS/Box Quan. per CTN Quantity (Tests)
MAL 421 Malaria Pf/Pv Ag Test Card Whole Blood 25 Bulk: 1600 PCS
Boxed: 40 Boxes
MAL 422 Malaria Pf/Pv Ab Test Card serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
MAL 423 Malaria Pf/Pan Ag Test Card serum/WB/plasma 25 Bulk: 1600 PCS
Boxed: 40 Boxes
How to Use

Malaria Pf/Pv Ag Test Card

General Information

(IVD Kit »-» Arthropod Borne Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:MAL 421
Description:Malaria Pf/Pv Ag Test Card
Category:Arthropod Borne Disease
Style:Card
Unit:PCS
Specimen:Whole Blood
No. of Step:One Step
Reading Time:20-40 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:90%
Specificity:99.5%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Specimen Diluents;
  • Instruction leaflet.

Specimen

Blood Collection with Venipuncture

Collect the whole blood into the collection tube (containing EDTA, citrate or heparin) by venipuncture.

Blood Collection with Lancet

Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet.

Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Whole Blood Storage Condition

It is preferable to test the specimen immediately after blood collection.

If specimens can’t be tested immediately but can be tested within three days, they should be refrigerated at 2 ~ 8°C. For storage periods longer than three days, freezing is recommended.

Before testing, they should be brought to room temperature prior to use.

Storing the specimen for more than three days may lead to non-specific reaction, thus affect the specificity of the testing results.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Malaria Pf/Pv Ab Test Card

General Information

(IVD Kit »-» Arthropod Borne Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:MAL 422
Description:Malaria Pf/Pv Ab Test Card
Category:Arthropod Borne Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:5-20 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:89.8%
Specificity:98.5%
Method:Lateral Flow Double Antigen Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Specimen Diluents;
  • Instruction leaflet.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

serum/WB/plasma Storage Condition

Test specimens as soon as possible after collecting.

The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antigen Sandwich

GICA Double Antigen Sandwich Method Illustration

Double antigen sandwich technology is commonly used to detect total antibody, which include IgM, IgG and IgA antibodies, which all can react and bound to specific antigen. In the lateral flow double antigen sandwich chromatographic rapid test, recombinant or purified antigens are used to capture and detect the total antibodies specifically.

In the test band region, purified or recombinant antigens or proteins are immobilized. In the end of the membrane strip where the samples are supposed to be added, another antigen conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antigen conjugate particles resolve into the specimen, where the antigen conjugate will react and bound to the target antibodies, if present.

This antibody-antigen conjugate complex then moves along the strip to the testing band region, under capillary effect. Where the immobilized antigen captures the complex, and the antigen-antibody-antigen-colloidal gold complex is fixed on test band region. When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target antibody in the specimen, the colloidal gold particles will not congregate on the test band region, and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle

Malaria Pf/Pan Ag Test Card

General Information

(IVD Kit »-» Arthropod Borne Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:MAL 423
Description:Malaria Pf/Pan Ag Test Card
Category:Arthropod Borne Disease
Style:Card
Unit:PCS
Specimen:serum/WB/plasma
No. of Step:One Step
Reading Time:15 Minutes
Cut Off:
Specification:4.0 mm
Quan. or Qual.:Qualitative
Sensitivity:99%
Specificity:99%
Method:Lateral Flow Double Antibody Sandwich

Packing Specification

Tests per Kit:25 Tests
Box Dimension:21.0 * 12.5 * 6.5 CM
Kits per CTN:40 Kits
Carton Dimension:53 * 45 * 36 CM
Tests per CTN (BULK):1600 Tests
Carton Volume:0.085 CBM
GW per CTN (Boxed):14.0 KG
GW per CTN (Bulk):16.5 KG

Materials Provided in the Test Kit

  • Test cassette in single foil pouch with desiccant;
  • Disposable sample dropper;
  • Specimen Diluents;
  • Instruction leaflet.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

serum/WB/plasma Storage Condition

Test specimens as soon as possible after collecting.

The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Double Antibody Sandwich

GICA Double Antibody Sandwich Method Illustration

In the double antibody sandwich lateral flow chromatographic rapid test, two antibodies are used to detect viral protein or antigen.

In the test band region, antibody specific to the target antigen or protein is immobilized. In the end of the membrane strip where the samples are added, another antibody conjugated with colloidal gold particles is embedded.

During the testing process, specimen from the patient is added to the end of the membrane strip. The antibody conjugate particles will resolve into the specimen, where the antibody conjugate will react and bound to the target protein or viral antigen, if present.

This antigen-antibody conjugate complex then moves along the strip to the testing band region, under capillary effect. The immobilized antibody in the test line region then bound to another binding site on the antigen complex, and the antibody-antigen-antibody complex is fixed on test band region.

When the complex congregates, the highly concentrated colloidal gold particles will develop some red or pink color, indicate a positive result.

If there is no target protein or antigen in the specimen, the colloidal gold particles will not congregate and no color will develop, indicating a negative result.

Information | Packing | Specimen | Principle