Malaria Pf/Pv Ag Test Cassette

Malaria Pf/Pv Ag Test Cassette (疟原虫pf/pv抗原快速测试卡) is a one-step qualitative lateral flow rapid diagnostic test kit, based on the Colloidal Gold Chromatographic Immuno Double Antibody Sandwich principle, which is used to detect Malaria Pf/PV antigens in human Whole Blood specimen.

Please refer to the Instruction for Use (IFU) of the Malaria Pf/Pv Ag Test Cassette. (For reference only; Read the package insert in the test kit before performing any test.)

Detailed information of Malaria Pf/Pv Ag Test Cassette

  1. General and Technical information of this MAL test kit;
  2. Packing specification of this MAL Card style test kit (gross weight in full kit package and in bulk packing);
  3. Specimen used to carry out the assay, and the requirements on specimen collection, storage and processing; and,
  4. Specific immuno assay principle used in this Malaria Antigen Test Kit.

Main technical information of this Malaria Pf/pv Ag test kit is listed in the following table:

Catalog No.:MAL 421
Description:Malaria Pf/Pv Ag Test Cassette
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%
Assay Principle:Colloidal Gold Chromatographic Immuno Double Antibody Sandwich

The standard kit size of this Malaria Antigen Card test kit is 25 tests per box; 40 boxes per carton.

To save freight cost, sometimes bulk packing is used, meaning test strip, cassette or multi-test panel is packed in single aluminum pouch; 50 or 100 pouches in one plastic bag; and then plastic bags are packed in cartons along with the unfolded boxes for the test kits. In this way, the customers can easily pack the tests into test kits after receiving the bulk packed goods.


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

Materials Provided

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

To carry out the assay with a Malaria Pf/Pv Ag Test Cassette, Whole Blood should be collected according to the instructions given in the Instruction For Use included in the test kit. After collecting, it is preferable to perform the testing as early as possible; if not viable, the specimen should be stored properly. A general introduction about the collection, and storage of the specimens is given below.

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.

Colloidal Gold Chromatographic Immuno Double Antibody Sandwich method is used in this Malaria Pf/Pv Ag Test Cassette to detect the Malaria Pf/PV antigens in human Whole Blood specifically. The introduction of this Colloidal Gold Chromatographic Immuno Double Antibody Sandwich testing principle is given blow.

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.