A simple and practical method of assessing anemia, consisting of a portable device that measures the concentration of hemoglobin in the blood and instantly gives the result, is in the final validation phase. Hemoglobin, a protein found in the red blood cells and plasma, which is responsible for transporting oxygen, is the main measure used to indicate a lack of iron in the organism, i.e., iron deficiency anemia. The device was developed to meet the needs of public health programs, but it could also be used in clinics. A prick on the finger is enough to draw the blood with a pipette, which is promptly transferred to a flask with reagent. Once the liquid content becomes homogeneous, the flask is inserted into a particular spot in the equipment. The reading is taken using a photometer, which consists of a green LED, this being a wavelength that the hemoglobin molecule absorbs, and a light detector on the other side.
“The beam of light measures the fraction of luminous energy absorbed by the sample,” explains Paulo Alberto Paes Gomes, a physicist and the coordinator of the project funded by FAPESP through its Innovative Research Program for Small Companies (Pipe). Based on the amount of light absorbed, one can calculate the amount of hemoglobin in the sample. All one needs to do is to press a button and the result appears on a display. The reading of the hemoglobin patterns, which correspond to normal or low values, is carried out by a pre-programmed chip. “It is estimated that about 17% of Brazilian children aged 4 to 6 have iron deficiency anemia; this is a serious public health problem, because this is the age the nervous system is growing and, as a result of this, learning is negatively affected,” explains Jair Ribeiro Chagas, a professor from the Health Sciences Department of the Federal University of Sao Paulo (Unifesp) who is involved with the research.
A portable Swedish device is currently the main reference for hemoglobin measurement. The only difference being that, instead of the flask, a small slide carries the drop of blood into the device that measures it. The new method for reading and measuring the protein has enabled a patent request that, with FAPESP’s help, has been filed with the National Industrial Property Institute (INPI). The price of the device and the cost of the tests are both cited by the researchers as factors that favor the Brazilian device. “The imported equipment costs about R$4 thousand, while the one we have developed should, at most, come to R$2 thousand, including taxes,” says Chagas. “The test with the flask and the reagent costs about R$1.50, even on a small scale, while other methods cost R$5.00 to R$7.00,” stresses Gomes.
The researchers’ initial idea was to work on developing a device to measure the angiotensin converter enzyme, angiotensin being an important protein in the treatment of high blood pressure. “We wanted a device that would make it easier to measure this enzyme in a lab,” recalls Chagas, who works with proteolytic enzymes. At this time, in 2004, the researcher was the assistant dean of research and post-graduate studies at the University of Mogí das Cruzes (UMC), after taking leave of absence from Unifesp. It was at the university that he met Gomes, who, after having done a degree in physics and completing his doctorate in biomedical engineering at the State University of Campinas (Unicamp), set up a biomedical engineering research group focusing on heart electrophysiology with funding from FAPESP’s Young Researchers’ Program. When they finally decided to start the development work, Gomes, who was no longer working for the university, assumed responsibility for the project at the company Sépia, which was housed within Intec, Mogí’s technological business incubation program. The third partner in the company, Maurício Marques de Oliveira, who has a degree in veterinary science from the University of Sao Paulo and a master’s degree in biomedical engineering from UMC, joined the group at the start of 2006.
The initial idea was expanded to include the measurement of other variables, such as hemoglobin, sodium, potassium, glucose and cholesterol, all in a single piece of equipment. At the end of 2006, during the project’s development, a request was issued for proposals of new technologies to be incorporated within the so-called Single Healthcare System (SUS), a partnership between the Ministry of Health, the Department of Health of the State of Sao Paulo and FAPESP. Since the research was ahead of schedule and a first prototype for measuring hemoglobin was already available, the researchers presented the equipment to Mário Maia Bracco, the doctor in charge of the Cruz de Malta Assistance Center, a NGO that operates in the Jabaquara area, in the Southern part of the city of Sao Paulo, in order for him to evaluate the technology used and assess the possibility of applying it within SUS. Cruz de Malta, which has an agreement with Unifesp in the areas of nursing, ophthalmology and pediatrics, has an out-patient clinic that serves the neighborhood’s mothers and children. The project was approved by FAPESP and by the university’s ethics committee.
“During the validation phase, more than a hundred children aged 4 to 6 were evaluated, using our device, the imported one, bought for the evaluation, and the normal laboratory equipment that they were already using at the clinic,” explains Chagas. Agents of Unifesp’s Family Health Program also took part in this stage. Besides the blood test, the children’s weight and height were also measured. “There was a very high level of anemia among the children, between 20% and 21%,” he highlights. After proving that the equipment did indeed work, an agreement was reached with the town council of Ilhabela, an island off the northern part of the state of Sao Paulo coast, to also evaluate children who were not yet of school age. During this stage a total of 670 children were evaluated. “18% of these children showed signs of anemia,” states Chagas. All the families of the children that showed signs of anemia were sent a letter with nutritional recommendations and after 45 and 90 days new tests were carried out to measure the hemoglobin level in the children’s blood. Once this stage was over, the researchers proposed expanding the study to include other places, such as the city of Santa Luzia do Itanhi, on the coast of the state of Sergipe, the mouth of the Amazon River and outlying areas of the city of Sao Paulo. “Our objective was to evaluate the use of the equipment in a wide range of settings and environmental and social conditions,” explains Oliveira.
In July of this year a team comprising the pediatrician Juliana Teixeira and researchers from the group spent ten days in the town in the state of Sergipe, evaluating all the children of pre-school age. “A total of 230 tests were carried out, with anemia being diagnosed in 22% of the children,” recounts Gomes. During the second week of August, Bracco paid a visit by boat to riverside communities at the mouth of the Amazon River, in the state of Amapá, to test the equipment’s effectiveness. In this case a total of 370 adults and children were evaluated, with more than 40% of the sample showing signs of anemia.
Based on the results presented, it can be concluded that the equipment met all the requirements in a variety of environments. “Although it is a side effect of the main project, this device is very interesting from the public health point of view,” states Chagas. As for the multi-functional device for measuring potassium, sodium and other variables, an initial prototype is now ready, but it has yet to be validated, which includes ten different tests.
1. Simplified fluoride meter to measure the activity of the angiotensin converting enzyme (ACE) in biological fluids (nº 04/14274-6); Type Pipe – Innovative Research Program for Small Companies; Coordinator Paulo Paes Gomes – Sépia; Investment R$ 326,778.35 (FAPESP)
2. Request for aid to take out a patent for the HB-010 portable hemoglobin meter and the associated method (nº 06/61239-7); Type Aid to Industrial Property Program; Coordinator Paulo Paes Gomes – Sépia; Investment R$ 6,000.00 (FAPESP)
3. Evaluation of the technology employed in the HB-010 hemoglobin meter and possibilities for its application by the Single Healthcare System (SUS) – FAPESP-CNPq-SUS agreement (nº 06/61907-0); Type Program of Research for SUS – Public Policies; Coordinator Mário Bracco – Cruz de Malta; Investment R$ 178,185.00 (FAPESP)