Malaria Pf/Pan Antigen Rapid Test Kit (Colloidal Gold)

[Product Name]

General name: Malaria Pf/Pan Antigen Rapid Test Kit (Colloidal Gold)

【Packing Specification】

25 persons/box

【Intended Use】

It is suitable for qualitative detection of Pf-specific lactate dehydrogenase of Plasmodium falciparum (Pf-LDH) and Pan-specific lactate dehydrogenase LDH of Plasmodium panparum (Pan-LDH) in human whole blood samples in vitro.

【Test Principle】

This product uses immunochromatographic technology to detect Malaria Pf/Pan Antigen by double antibody sandwich method. During detection, the sample is dropwise added into a sampling well of the test card. When a sample to be detected contains Pf-LDH and Pan-LDH antigens and the antigen concentration is higher than a minimum detection limit, the Pf-LDH and Pan-LDH antigens and the labeled antibody form a reaction complex firstly, which moves forward along the nitrocellulose membrane under the chromatographic action, and captured by monoclonal antibodies to anti-Pf-LDH and anti-Pan-LDH in detection zones (2) and (or)(1) of the nitrate fiber membrane, respectively, and finally forms a red/pink reaction line in the detection zone (2) and (or) zone (1) without influenza A, the result is positive at this time. Conversely, when the samples are free of Pf-LDH and (or) Pan-LDH antigens or the antigen concentration is below the minimum detection limit, no red/pink reaction line will display in the detection zone and the result is negative. Regardless of whether the sample contains Pf-LDH and Pan antigen, the quality control (C) will form a red/pink reaction line. The red/pink reaction line displayed in the quality control area (C) is the standard to determine whether the chromatography process is normal, and also serves as the internal control standard of the reagent.

【Main Component】

Ingredients	Qty./Spec.	Main components:
Test card (with desiccant)	1 person/bag	Each detection card is mainly composed of a plastic shell and a test strip. The nitrocellulose membrane, the main part of the test strip, is coated with an anti-Pf-LDH monoclonal antibody and/or an anti-Pan-LDH monoclonal antibody and rabbit IgG. The binding pad is coated with the colloidal gold-labeled anti-Pf-LDH monoclonal antibody and/or an anti-Pan-LDH monoclonal antibody and the colloidal gold-labeled sheep anti-rabbit IgG antibody. Other components include polyester film, and absorption paper, etc.
Sample diluent	25 pieces/box	Mainly phosphate buffer solution (PBS) (0.1 M, pH7.2±0.2).

[Components required for testing but not provided]: 

timer, 10ul range micropipette and associated nozzles, centrifuge

[Storage Conditions and Validity】

This kit is kept at 2~30℃, under sealed state of aluminum foil bag. Its shelf life is 18 months. After the unsealing of aluminum foil bag, this kit should be used within one hour. The sample extracts should be capped immediately after use and placed in a cool place or refrigerator. Production date and expiry date are shown in the package or label.

[Sample Requirements]

1.          Venous blood collection:

a)          Collect whole blood by venipuncture and put it into anticoagulation tube containing EDTA. All specimens should be treated as infectious factors.

b)          Whole blood samples should be stored at 2-8℃ for three days after collection.

c)          Samples must be restored to room temperature before detection, and mixed evenly before use.

2.          Fingertip blood collection:

a)          Disinfect the blood collection part with alcohol, squeeze the blood collection part with fingers, and puncture the skin with a sterilized lancet to collect blood.

b)          Wipe off the first drop of blood with sterilized gauze or cotton. Contact to collect blood with dropper.

[Test Method]

1.      Please read the instructions carefully before testing.

2.      When stored at low temperature, the kit and collected experimental samples should be restored to room temperature before use.

3.      Aluminum foil bag is torn off. Test card is taken out, and put flatly onto the surface of operating table.

4.      Whole blood sample is drawn through pipette separately at 10ul, and then dripped into sample injection hole of test card. The cap of bottle for sample buffer solution enclosed in the kit is rotated off; and the bottle for sample buffer solution is inverted. The sample buffer solution is dripped vertically by 3 drops (about 80ul) into sample injection hole. Then, the timing is started.

5.      At 10~15 minutes, final result is read. After 15 minutes, test result must not be read. The results displayed after 30 minutes have no clinical significance.

6.      Note: The test had better be completed under room temperature (15~30℃).

[Interpretation of Test Results]

Positive for Malaria Pf: Two red/pink reaction lines appear, one in Zone 2 and one in Zone C (quality control zone).

Positive for Malaria Pan: Two red/pink reaction lines appear, one in Zone 1 and one in Zone C (quality control zone).

Positive for Malaria Pf/Pan: Three red/pink reaction lines appear, one in Zone 2, one in Zone 1 and one in Zone C (quality control zone).

Negative: Only one red pink reaction line appear in Zone C and no red/pink bands are observed in Zone 2 and Zone 1.

Invalid: In case that no red/pink reaction line appears in the quality control zone C, the test is invalid, and it is recommended to retest with a new test card at this time.

Note: The color development of reaction line is related to the content of the tested substance in the extracted sample. The result should be determined according to whether the reaction line develops color, regardless of the color intensity.

This reagent contains the quality control process. When a red/pink reaction line appears in Zone C, indicating that the operation is correct and effective. Otherwise, the detection is invalid.

Standard Laboratory Practice (GLP) Laboratories recommend that quality control be conducted in accordance with laboratory procedures and guided by national or local regulations.

[Limitations of Test Method]

1.        The kit is limited to in vitro diagnosis, and it is only used for qualitative detection of Plasmodium falciparum Pf and Plasmodium Pan in human whole blood samples. Please refer to the relevant professional instruments for the testing of the specific content of an indicator.

2.        The accuracy of the test depends on the sample collection process. Improper sample collection, improper sample storage, stale samples, or stale samples will affect the test results.

3.        The test results with this reagent are for clinical reference only and cannot be used as the only basis for clinical diagnosis and treatment. Clinical management of patients should be comprehensively considered in reference to their symptoms/signs, medical history, other laboratory tests, and treatment response.

4.        Reagents with different batch numbers cannot be mixed.

5.        Analysis of the possibility of false negative results:

a)          Unreasonable sample collection, transportation and treatment, and low antigen concentration in samples may lead to false negative results.

b)          Plasmodium genetic variation may cause antigenic determinant changes resulting in false-negative results, which are more likely to occur with reagents that use monoclonal antibodies.

[Product Performance Indicators]

1.        LOD: Pf-LDH LOD: 8pg/mL; Pan-LDH LOD: 24pg/mL.

2.        Coincidence rate of positive reference: Compared with the results of microscopic examination, the coincidence rate of Pf-LDH positive reference is 97.2%, and the coincidence rate of Pan-LDH positive reference is 97.82%.

3.        Coincidence rate of negative reference: Compared with the results of microscopic examination, the coincidence rate of Pf-LDH negative reference is 98.16%, and the coincidence rate of Pan-LDH negative reference is 98.67%.

4.        Intra-batch precision: Ten test cards are randomly selected from the same batch of Pf antigen or Pan antigen test kit products. Through the enterprise internal control reproducibility reference material (C1 and C2), a parallel test is made. The test results should all be positive; and the colority should be not obviously different under macroscopic observation.

5.        Inter-batch precision: Take three consecutive batches of products from Pf antigen or Pan antigen detection kit products (at least three people in each batch). Through the enterprise internal control reproducibility reference material (C1 and C2), a parallel test is made. The test results should all be positive; and the colority should be not obviously different under macroscopic observation.

6.        Cross-reaction: In order to analyze the analytical specificity of the kit, 20 kinds of pathogenic microorganisms that may exist in blood (5 kinds of bacteria such as Borrelia burgdorferi, Leptospira hyperbola and Treponema pallidum, 5 kinds of protozoa such as Babesia, Kuruz vertebral parasite and Leishmania donovani, and 10 kinds of viruses such as cytomegalovirus, dengue virus, yellow fever virus and hepatitis B virus) are detected. The results indicate that there is no cross reaction between this kit and these pathogenic microorganisms.

7.        Interfering substances: hemoglobin, heme and triglyceride do not interfere with this reagent; and anticoagulants heparin, EDTA, sodium citrate and potassium oxalate do not interfere with this reagent.

8.        Drug effects: Drugs used to prevent or treat malaria, such as mefloquine, quinine, flavamine, amoxicillin, cefalin, erythromycin and aspirin, have no influence on the detection results of this kit.

[Precautions]

1.              The kit is only use for in vitro diagnosis. Do not reuse or use expired products.

2.              Do not eat, drink or smoke during the experiment.

3.              Wear protective clothing and disposable gloves when operating, and note to protect eyes.

4.              No color bands appear on either the control or test lines, indicating that an error occurs and the test should be repeated.

5.              Test environment should not be at too high temperature. Test card of low-temperature storage should first be restored to room temperature and then opened, so as to avoid a moisture absorption.

6.              There is a desiccant in the aluminum foil bag, which should not be taken orally.

7.              Do not use if the aluminum foil bag is damaged or the product is damaged before use.