Accurate Whole Blood Malaria Pf/ Pv Test Malaria Rapid Test

Description

Ji'an Bio's malaria detection kit has an accuracy rate of 98%. The detection wait time is short. Use a malaria test kit as soon as possible to test for the virus. Malaria is a contamination disease transmitted by Plasmodium parasites through mosquito bites. Clinically, it is characterized by periodic attacks of chills, high fever, sweating, and fever, as well as anemia and splenomegaly. Due to differences in protozoa strains, degree of infection, immune status, and body reactivity, clinical symptoms and attack patterns vary.

Malaria is widely prevalent all over the world. According to the statistics of the World Health Organization, there are still 92 countries and regions with high and moderate epidemics, with an annual incidence of 150 million and more than 2 million deaths from malaria. Before the liberation of my country, malaria was prevalent year after year, especially in the south. Due to the rampant epidemic, the case fatality rate was very high. After liberation, malaria prevention and control institutions were established across the country, and malaria prevention and scientific research work were carried out extensively. The incidence of malaria has dropped significantly.

We all have a different kind of rapid test kits. For example, Medical Level Self Rapid Test Kits 15-20 Minutes Virus Antigen Flu A B Rapid Diagnostic Test Kit, Dengue Fever Rapid Test Kits, covid-19, and so on.

Specification

rapid test kit.pdf

Picture details

CE Approved

All our rapid test kits have CE certifications that can be downloaded.

15 types of fast test ce certifications.pdf

Product Performance Indicators

Coincidence rate of positive reference:

Compared with the results of the microscopic examination, the coincidence rate of Pf-LDH positive reference is 97.2%, and the coincidence rate of Pv-LDH positive reference is 96.82%.

Coincidence rate of negative reference:

Compared with the results of the microscopic examination, the coincidence rate of Pf-LDH negative reference is 98.16%, and the coincidence rate of Pv-LDH negative reference is 97.97%.

Intra-batch precision:

Ten test cards are randomly selected from the same batch of Pdf antigen or Pv antigen test kit products. Through the enterprise's internal control reproducibility reference material (C1 and C2), a parallel test is made. The test results should all be positive, and the colors should be not different under macroscopic observation.

Inter-batch precision:

Take three consecutive batches of products from Pf antigen or Pv antigen detection kit products (at least three people in each batch). Through the enterprise's internal control reproducibility reference material (C1 and C2), a parallel test is made. The test results should all be positive, and the colors should be not different under macroscopic observation.

Cross-reaction:

To analyze the analytical specificity of the kit, 20 kinds of pathogenic microorganisms that may exist in the 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.

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.

Drug effects:

Drugs used to prevent or treat malaria, such as mefloquine, quinine, fluvoxamine, amoxicillin, cefalexin, erythromycin, and aspirin, do not influence the detection results of this kit.

About us

Our company is a comprehensive high-tech enterprise that integrates R&D manufacturing, sales, and service. We focus on the third category of medical equipment and biomedical consumables(IVD systems).
Our company is located in the High-tech Zone of Kunshan City, Jiangsu Province, with a land area of nearly 20,000square meters and a workshop area of 12000 square meters has a 5.000-square-meter purification workshop that reaches the 100.000-level standard and is equipped with 40 sets of advanced machines with several fully automatic assembly lines. We also have an R&D team and a microbiological laboratory.
Our company has passed the ISO13485: 2016 quality system certification and the products have obtained the European Union CE certification, which allows us to provide a complete set of services from product design, mold making, and production, etc, and accept OEM/ODM customized services.
Our company takes"caring for human health" as its original intention and "improving the quality of life" as its mission. Adhering to the corporate core values of "caring for life,health-oriented; giving back to the society and culture inheritance", we will wholeheartedly provide high-quality products and the best services to users in the medical and health industry.