The Oswaldo Cruz Foundation produces kits and reagents for diagnosing several diseases, aiming to meet the endemic and injury control programs from the National Health Foundation (Funasa) and sexually transmitted diseases. Those kits are developed in Biomanguinhos, manufacturing unit that is located in their central campus, in Rio de Janeiro. They are:
It supplements the serology tests offered at the blood centers all over the country, increasing safety on transfusions. It uses an automated platform with a large capacity of processing that allows simultaneous analysis of up to 552 blood bags per routine, with high traceability and sensitivity for detecting HIV (the AIDS virus) and HCV (the hepatitis C virus). Thus it’s possible to detect pathogenic agents that are transmissible by blood transfusion in a shorter period of time than the usual tests used in blood centers. The goal is to analyze up to 3.5 million blood bags annually, fully covering the Brazilian public blood network.
Used for serologic screening through a blood, serum or plasma drop, or oral fluid. It’s a more precise, sensitive and simpler method and with quicker results. They are produced and distributed to the Ministry of Health.
It’s an innovative test, with no competition in the current market, that provides confirmation of HIV infection in up to 20 minutes. This new test generates significant resource savings for the Ministry of Health, since its cost is about five times less than the current standard test, which has a confirmation period of up to a month. The new diagnosis kit is more sensitive and specific, providing more precise and reliable results. Another advantage is that its application doesn’t take a laboratory structure, reaching Brazilian people that live in more remote areas, increasing access to diagnosis. The exam is distributed by the Ministry of Health to the public Testing and Advising since 2011.
To treat syphilis, Biomanguinhos offers an immunochromatographic test for detecting specific antibodies for Treponema pallidum in total blood, serum or human plasma. It’s for point-of-care use, to help diagnose the infection, and it’s the adequate test for use of multitests algorithms for statistic assessment of the results of quick syphilis tests. The examination offers several benefits: easy execution on the field: it doesn’t need equipment or laboratory structure; simple reading and interpretation: makes training of health professionals easier; quick diagnosis: contributes for an immediate clinical decision-making about the need of treatment and notification; more sensitivity and specificity: makes screening and confirmation of the serological status possible, with better indication about the activity of the disease, what brings to directing the monitoring and controlling actions.
The quick test DPP® Visceral Canine Leishmaniasis is the only one available in the current market, offering results within about 15 minutes. It doesn’t need a laboratory structure and equipment, making field use easier. It has high sensitivity technology, what brings accuracy to the visceral canine leishmaniasis diagnosis in serum blood or plasma. Because it is a screening test, it allows only the positive cases to be taken for confirmation, thus dispensing the laboratory.
The quick test DPP® Leptospirose, from the line of reactives for diagnosis of Bio-Manguinhos, is essential for the laboratory or field diagnosis actions of the municipal health services, that are supported by the Health Inspection Office (SVS). Its technology allows reducing the response time of the laboratory diagnosis and the amount of procedures undertaken, improving the final quality of the result of the testing for the disease.
The serological assay of Indirect Immunodeficiency (IFI) Canine Leishmaniasis is a confirmation examination, and its result can be obtained after 24 hours after it’s done. Soon this test will be discontinued and replaced by the Quick Test DPP® Canine Leishmaniasis, that will screen the cases, with confirmation by the serological assay Elisa.
The serological assay of Indirect Immunofluorescence (IFI) Human Leishmaniasis follows the same methodology of the canine leishmaniasis test. IFI is the standard diagnosis for American Tegumentary Leishmaniasis in humans.
To detect the present of the protozoan Trypanosoma cruzi or T. cruzi in the organism, the recommendation is the IFI method – indirect immunofluorescence – due to its features of high specificity and sensitivity and the standardization of its execution. This method allows identification of antibodies of the IgM kind, associated to the acute phase of the disease. The IFI method is also often used to confirm positive, doubtful or negative results obtained with the IHA (hemagglutination inhibition) and EIE (Elisa assay) methods.
The immunoenzymometric serological assay Elisa is considered a screening method and its results are commonly expressed in reagent or non-reagent. Its sensitivity varies from 71 to 100% and its specificity, between 85 and 100%; the factors that influence these variables are the antigen used (rough or recombinant) and the standard protocol (time of incubation and kind of microplate used). The use of rough or total antigens limits the specificity of Elisa, allowing crossed reactions with trypanosomatids. The use of recombinant antigens, specific of the Leishmania kind, improves both the specificity and the sensitivity of this test.
It is a qualitative-quantitative test based on the technology of the Kato-Katz method. The parasitological examination allows revealing helminth eggs present in the stool samples, such as: Ascaris, Schistosoma, ancylostoma, Trichuris, Taenia and, less often, Enterobius and Strongyloides. The kit identifies the prevalence of illnesses such as schistosomiasis, allowing the Ministry of Health to increase the inspection and monitoring actions for parasitary diseases, on top of working on its prevention.