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Malaria Antigen PF/PV Card Test

Rapid Malaria pf/pv Antigen Test Card Intended Use Malaria pf (HRP II) / pv (LDH) Antigen Test is for the rapid qualitative determination of Malaria P. falciparum specific histidine rich protein-2 (Pf HRP-2) and Malaria P. vivax specific lactate dehydrogenase (pvLDH) in human blood as an aid in the diagnosis of Malaria infection. Contents of Kit Malaria pf/pv Antigen Test Card 25 ea Malaria Sample Buffer 1 ea Instructions For Use 1 ea Storage And Stability The kit can be stored at room temperature or refrigerated (4-30ípC). 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. Pre Cautions 1. For professional in vitro diagnostic use only. Do not use after expiration date. 2. Do not eat, drink or smoke in the area where the specimens or kits are handled. 3. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens. 4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are being tested. 5. Humidity and temperature can adversely affect results. 25 tests/kit, 40 kits/carton

Specification Strength/ Size Packing Size Packed In Malaria Antigen PF/ PV Card Test 50 Tests 50 Box Pack  

Specification Strength/ Size Packing Size Packed In Malaria Antigen PF/ PV Card Test 50 Tests 50 Box Pack   Malaria Antibody PF/ PV Card Test 50 Tests 50 Box Pack  

Product Details: Number of Reactions(Preps)/Kit 25 T Brand Premier Result Time (Rapid Kits) 20 -30 MIN Certified WHO Aproved CAT No; PI13FRC25 First Response Malaria Antigen P.falciparum (HRP2) Card Test is intended to be performed by trained users (In either laboratory or point of care settings) as qualitative screening in vitro diagnostic test for detection of P. falciparum specific HRP2 antigen. Sensitivity - 100% Specificity - 100% Rapid Result time within 20 - 30 Minutes. Detects Histidine Rich protein(HRP2) of Plasmodium P.falciparum Storage at 1 40 C. Specimen Type- Whole Blood

INTENDED USE The Malaria Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax, P. ovale, or P. Malariea antigen in whole blood. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria Rapid Test must be confirmed with alternative testing method(s) and clinical findings. SUMMARY AND EXPLANATION OF THE TEST Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P.ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P. falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution1. Traditionally, malaria is diagnosed by the demonstration of the organisms on Giemsa stained smears of peripheral blood, and the different species of plasmodium are distinguished by their appearance in infected erythrocytes1. The technique is capable of accurate and reliable diagnosis, but only when performed by skilled microscopists using defined protocols2, which presents major obstacles for the remote and poor areas of the world. The Malaria Rapid Test is developed for solving these above obstacles. It detects the antibodies generated in serum or plasma in response to the infection of plasmodium. Utilizing the Pf. specific antigen (HRP-II) and pan-malaria antigen (aldolase), the test enables simultaneous detection and differentiation of the infection of P.falciparum and or P. vivax, ovale, and malariae3-5, by untrained or minimally skilled personnel, without laboratory equipment.

A rapid test for the qualitative detection of circulating antigens of Plasmodium falciparum, Plasmodium vivax, Plasmodium ovale, Plasmodium malariae in whole blood. For professional in vitro diagnostic use only. Sensitivity The Malaria P.f/ Pan Rapid Test Device (Whole Blood) has been tested with thin or thick microscopy on clinical samples. The results show that the sensitivity of the Malaria P.f/ Pan Rapid Test Device (Whole Blood) is >99.9% relative to microscopy. For Pan: Relative Sensitivity: >99.9% (158/158) (97.6%100.0%)* For P.f: Relative Sensitivity: >99.9% (53/53) (93%100.0%)* Specificity The Malaria P.f/ Pan Rapid Test Device (Whole Blood) uses highly specific antibodies for Malaria P.f/ Pan antigens in whole blood. The results show that the specificity of the Malaria P.f/ Pan. Rapid Test Device (Whole Blood) is over 99.0% relative to microscopy. Relative Specificity: >99.0% (324/327)(97.3%99.8%)* Accuracy: >99.4%(535/538)(98.3%99.8%)* * 95% Confidence Interval Total Results211327538 Note: The comparison for Pan line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan lines are based on scientific findings that Pan-malarial Aldolase is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae.

"FactView Malaria Rapid PF/PV" likely refers to a diagnostic test for the rapid detection of Plasmodium falciparum (PF) and Plasmodium vivax (PV), two species of malaria parasites. Here's more information about this type of diagnostic test: Purpose: The FactView Malaria Rapid PF/PV test is used for the rapid detection of malaria infection caused by the Plasmodium falciparum and Plasmodium vivax parasites. Malaria is a serious infectious disease transmitted by the bite of infected Anopheles mosquitoes. Principle: The test is based on immunochromatographic principles, where specific antibodies are used to detect the presence of malaria antigens in a patient's blood sample. The presence of the PfHRP2 antigen indicates P. falciparum infection, while the presence of the pLDH antigen indicates P. vivax infection. Components: The FactView Malaria Rapid PF/PV test typically includes test cassettes, sample droppers, buffer solutions, and desiccants. The test cassettes contain pre-coated membranes with specific antibodies for detecting malaria antigens. Procedure: The test procedure involves collecting a small amount of blood from the patient (usually obtained via finger prick) and applying it to the sample well of the test cassette. Buffer solution is then added, allowing the blood sample to migrate along the test strip. Results are typically visible within 15-20 minutes. Interpretation: The appearance of colored lines on the test strip indicates the presence or absence of malaria antigens. A visible line in the control region indicates that the test is valid. Additional lines in the test regions indicate positive results for P. falciparum and/or P. vivax antigens. Sensitivity and Specificity: The FactView Malaria Rapid PF/PV test demonstrates high sensitivity and specificity for detecting malaria infections caused by P. falciparum and P. vivax parasites. However, like all diagnostic tests, false-positive and false-negative results are possible and should be interpreted in conjunction with clinical findings. Utility: Rapid diagnostic tests like the FactView Malaria Rapid PF/PV provide a quick and convenient method for diagnosing malaria infections in resource-limited settings, where access to laboratory facilities and microscopy may be limited. Limitations: While rapid diagnostic tests are valuable tools for malaria diagnosis, they have limitations compared to more sensitive methods such as microscopy or molecular testing. Factors such as test storage conditions, operator technique, and the stage of infection can influence test performance.

INTENDED USE The Malaria Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen in whole blood. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria Rapid Test must be confirmed with alternative testing method(s) and clinical findings. STORAGE Store the test kits at room temperature 4- 30 degrees C. The sealed pouch has a self life of 24 months.of transmitting disease.

Phoenix Bioscience Malaria P.f. Test Cassette is a rapid, qualitative test for the detection of circulating Plasmodium falciparum in whole blood, to aid in the diagnosis of malaria infection. It is intended for professional in vitro use only. Interpretation of test results are: positive (two lines), negative (one line), invalid (no lines or no Control line). PRODUCT INFORMATION Product Code: MAL-11C-40 Sample: Whole Blood Format: Cassette Quantity: 40 Tests/Kit Specificity: Plasmodium falciparum Antigen Accuracy: >99.9% Time to result: 10 minutes Test Principle: Lateral Flow Immunoassay CONTENTS Test Cassettes Disposable Specimen Droppers Buffer Solution Product Insert