K-MALARIA P.F/PAN COMBO TEST
What Is Malaria?
Malaria is a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito that feeds on humans. Typical symptoms of malaria infection are high fever, shaking chills, and a flu-like illness. Four kinds of malaria parasites infect humans: Plasmodium falciparum, P. vivax, P. ovale, and P. malariae. In addition, P. knowlesi, a type of malaria that naturally infects macaques in Southeast Asia, also infects humans, causing malaria that is transmitted from animal to human (“zoonotic” malaria). P. falciparum is the type of malaria that is most likely to result in severe infections and if not promptly treated, may lead to death. Although malaria can be a deadly disease, illness and death from malaria can usually be prevented.
K-MALARIA P.F/PAN COMBO TEST
Signs and symptoms of suspected malaria
The signs and symptoms of malaria are non-specific. Malaria is suspected clinically primarily on the basis of fever, or a history of fever. There is no combination of signs or symptoms that reliably distinguishes malaria from other causes of fever; diagnosis based only on clinical features has very low specificity and results in overtreatment. Other possible causes of fever must always be carefully considered. The focus of malaria diagnosis should be to identify patients who truly have malaria, to guide the rational use of antimalarial medicine.
In all cases, suspected malaria should be confirmed with a parasitological test. The results of immunochromatographic parasitological diagnosis should be available within a short time (< 2 h) of the patient presenting.
Early and accurate diagnosis is crucial for effective management of malaria disease and surveillance. Rapid diagnostic test (RDT) is a quick parasite-based diagnostic method recommended by WHO for all patients with suspected malaria before they are given treatment.
Effective and accurate diagnostic testing that can distinguish between malarial and non-malarial fever can help healthcare professionals to select the most appropriate treatment to reduce illness and death.
K-MALARIA P.F/PAN COMBO TEST
Parasitological diagnosis
The benefit of parasitological diagnosis relies entirely on an appropriate management response of healthcare providers. The two methods used routinely for parasitological diagnosis of malaria are light microscopy and RDTs. Rapid diagnostic tests detect parasite-specific antigens or enzymes that are either genus- or species-specific. Both microscopy and RDTs must be supported by a quality assurance programme.
K-MALARIA P.F/PAN COMBO TEST
When should malaria RDTs be used?
- Quality-assured malaria microscopy is not readily available.
- Patients who have received incomplete antimalarial treatment, in whom blood films can be negative. The RDTs detecting PfHRP2 (Plasmodium falciparum histidine-rich protein 2) can be useful.
- Patients with manifestations compatible with severe malaria, a series of blood films should be examined at 6-12h intervals, or an RDT (preferably one detecting PfHRP2) should be performed if the initial blood film examination is negative.
K-MALARIA P.F/PAN COMBO TEST
What are Rapid diagnostic tests for malaria diagnosis?
- RDTs are immuno-chromatographic tests for detecting parasite-specific antigens in a finger-prick blood sample.
- Some tests allow the detection of only one species (P. falciparum); others allow the detection of one or more of the other species of human malaria parasites (P. vivax, P. malariae and P. ovale)
- RDTs are simple to perform and to interpret, and they do not require electricity or special equipment.
- RDTs are available commercially in various formats, e.g. dipsticks, cassettes, and cards. Cassettes and cards are easier to use outside health facilities.
Since 2012, the WHO has recommended that RDTs should be selected in accordance with the following criteria, based on the results of the assessments of the WHO Malaria RDT Product Testing programme:
- For detection of P. falciparum, the panel detection score against P. falciparum samples should be at least 75% at 200 parasites/µL.
- For detection of P. vivax, the panel detection score against P. vivax samples should be at least 75% at 200 parasites/µL.
- The false positive rate should be less than 10%.
- The invalid rate should be less than 5%.
K-MALARIA P.F/PAN COMBO TEST
Pros and Cons
Advantages;
- Rapid determination if patients are suspectedly infected with malaria
- Rapid provision of results and extension of diagnostic services to the lowest-level health facilities and communities
- Fewer requirements for training and skilled personnel (for instance, a general health worker can be trained in 1 day)
- Reinforcement of patient confidence in the diagnosis and in the health service in general
Disadvantages;
- The use of RDT does not eliminate the need for malaria microscopy.
- RDTs may not be able to detect some infections with lower numbers of malaria parasites circulating in the patient’s bloodstream than the limit of detection of the test.
- There is insufficient data available to determine the ability of this test to detect the two less-common species of malaria, P. ovale and P. malariae.
- All negative RDTs must be followed by microscopy to confirm the result.
- All positive RDTs also should be followed by microscopy. The currently approved RDT detects two different malaria antigens; one is specific for P. falciparum and the other is found in all four human species of malaria. Thus, microscopy is needed to determine the species of malaria that was detected by the RDT.
- In addition, microscopy is needed to quantify the proportion of red blood cells that are infected, which is an important prognostic indicator.
K-MALARIA P.F/PAN COMBO TEST
What’s Inside
Individually foil-pouched test cassettes with a desiccant (25 packs)
Assay buffer (1 bottle)
Instructions for use
K-MALARIA P.F/PAN COMBO TEST
How malaria RDTs work
Current tests are based on the detection of histidine-rich protein 2 (HRP2), which is specific for P. falciparum, pan-specific or species-specific Plasmodium lactate dehydrogenase (pLDH), or pan-specific aldolase. The different characteristics of these antigens may affect their suitability for use in different situations, and these should be taken into account in programmes for RDT implementation.
Variations occur between products, such as targets and formats, though the principles of the tests are similar. Malaria RDTs detect specific antigens (proteins) produced by malaria parasites in the blood of infected individuals. Some RDTs can detect only one species (Plasmodium falciparum or P. vivax), while others detect multiple species (P. falciparum, P. vivax, P. malariae and P. ovale). Blood for the test is commonly obtained from a finger-prick.
K-MALARIA P.F/PAN COMBO TEST
What is K-Malaria P.f/Pan Combo Test (K Biosciences)?
The K-Malaria P.f/Pan Combo Test is a rapid, qualitative test for detection of histidine-rich protein II antigen (HRP-2) of Plasmodium falciparum and Plasmodium lactate dehydrogenase (pLDH) of all four malarial species, P. falciparum, P. vivax, P. malariae and P. ovale, in whole blood of suspected malarial infective cases. The test kit is intended to detect malarial infection for professional in-vitro diagnostic use only.
With malaria RDTs, the dye-labelled antibody first binds to a parasite antigen, and the resultant complex is captured on the strip by a band of bound antibody, forming a visible line (T-test line) in the results window. A control line (C-control line) gives information on the integrity of the antibody-dye conjugate, but does not confirm the ability to detect parasite antigen.
K-MALARIA P.F/PAN COMBO TEST
K-Malaria P.f/Pan Combo Test Cassette
Inside the cassette is a strip made of filter paper and nitrocellulose. Typically, a drop of blood is added to the RDT through one hole (‘A’ sample well), and then a number of drops of buffer usually through another hole (‘B’ buffer well). Buffer carries the blood along the length of the RDT.
K-MALARIA P.F/PAN COMBO TEST
How To Interpret The Results Of The K-Malaria P.F/Pan Combo Test
The presence of a positive line at “Pf” or “Pf and Pan” indicates P. falciparum infection.
The presence of a positive line at “Pan” indicates P. vivax, P. malariae or P. ovale infection, but not P. falciparum.
The positive or negative result detected from the specimens needs to be taken into consideration together with patient history and clinical symptoms related to malarial infection.
Negative result
P. falciparum infection.
P. falciparum infection.
P. vivax, P. malariae or P. ovale infection
K-MALARIA P.F/PAN COMBO TEST
Caution
Collecting blood
Whole blood collected by fingerstick or by venipuncture can be used with the K-Malaria P.f/Pan Combo Test. Collect whole blood using EDTA anti-coagulant.
Specimen Storage
Whole blood collected by fingerstick should be tested immediately. If whole blood collected by venipuncture using anti-coagulant is not immediately tested, the specimen should be stored at 2-8 °C up to three days, or at -20°C for several months.
Frozen Samples
The specimens should be brought to room temperature prior to use. Frozen samples need to be thawed and mixed well before testing. Do not freeze-thaw samples for more than three cycles.