Intended use 

For the rapid qualitative determination of Malaria P.falciparum specific histidine rich protein-2(Pf HRP-2)and malaria P.vivax specific lactate dehydrogenase (pLDH)in human blood as an aid in the diagnosis of Malaria infection.   

Summary 

Malaria is a serious paraitc 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 infected Anopheles mosquitoes.There are four kinds of malaria that can infect humans.There four kinds of malaria that can infect humans:Plasmodium falciparum,P.vivax,P.ovale,and P.malariae.In humans,the parasites migrate to the liver where they mature and release another form,the merozoites.

The One-Step Malaria pf(HRPⅡ)/pv(pLDH)Antigen Detection Test Device(Whole Blood) contains a membrane strip,which is pre-coated with two monoclonal antibodies as two separate lines across a test strip.One monoclonal antibody(test line 1)is specific to the p.falciparum histidine rich protein-2(Pf HRP-2) and another monoclonal antibody(test line 2) is pan specific to the lactate dehydrogenase of Plasmodium species (P.falciparum,vivax,malariae,ovale). Conjugate pad is dispensed with monoclonal antibodies conjugated to colloidal gold,which are specific to P.falcparum histidine rich protein-2(Pf HRP-2)and pan specific to the lactate dehydrogenase of Plasmodium species.

Materials 

 Materials Provided

   Test Device

   Assay Buffer

   Instructions for Use

 Materilas lot Provided

   Calibrated pipette

   Lancet

   Timer

Specimen Collection 

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

If specimens are not immediately tested,they should be refrigerated at 2~8.For storage periods greater than three days,freezing is recommended.They should be brought to room temperature prior to use. Using the specimen after long-term storage of more than three days can cause non-specific reaction.

When stored at 2~8℃,the whole blood sample should be used within three days.

Directions for Use 

1. Add 5μl of whole blood into sample well（S）,the small well.

2. Add two drops(60μl)of assay buffer into developer well.

3. Read the test result in 20 min.

Interpretation of Results 

Positive: In addition to a pink colored control (C) band,one or two distinct pink colored bands will also appear in the test (T) region. Please consult your physician to perform a much more detailed exam.

Negative: Only one colored band appears on the control (C) region. No apparent band on the test (T) region.

Invalid: A total absence of color in both regions is an indication of procedure error and/or the test reagent has been deteriorated.

Precautions 

For professional in vitro diagnostic use only,Do not use after expiration date.

Do not eat,drink or smoke in the arer where the specimens or kits are handled.

Handle all specimens as if they contain infectious agents.Observe established precoutions against mocrobiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.

Wear protective clothing such as laboratory coats,disposable gloves and eye protection when specimens are being tested.

Humidity and temperature can adversely affect results.

Storage and Stability 

The kit can be stored at room temperature or refrigerated(2-30℃)。

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

The test device must remain in the sealed pouch until use.Do not freeze.Do not use beyond the expiration date.

Campany information

Voyage Medical Co., Ltd is a professional company specialized in diagnostic rapid test devices and hospital beds. With our own factory, we provide worldwide customers the service of made-to-order manufacturing at competitive prices and good quality. Meet customer’s needs and achieve win-win situation has always been the goal of our efforts.

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