E!10253 Diagnostic product for patient testing

CD-CARD The life expectancy of HIV and AIDS patients has improved during recent years. To meet the increasing patient load new diagnostic tools are required, which are fast, reasonably priced and easy to use. CD-CARD is a new invention that measures two important parameters for monitoring HIV and AIDS patients - CD4 and CD8 cell counts. CD-CARD gives results within 10 minutes, which means blood sampling; diagnosis and follow-up treatment are performed on the same visit. In Western and industrialized economies CD4 and CD8 counts are made using complicated and expensive flow cytometer instruments in central laboratories. In non-industrialized and emerging economies Point-of-Care instruments are being adopted as the preferred platform. UNITAID - a WHO organization dedicated to ending HIV/AIDS, malaria and tuberculosis - makes the following comments and predictions about CD4 and CD8 in HIV-related treatment. " ... scale-up of CD4 testing is needed. POC technologies will make it possible not only to expand access to CD4 testing for patients in remote/rural areas, but also to return results to patients on the day of testing. The opportunities to further lower unit prices rest in new technologies, such as disposable CD4 tests, which may ultimately be priced at less than US$ 3 per test without the need for investment in instruments/devices." CD-CARD is a disposable card, designed for mass-production and using highly sensitive reagents. It requires a minimum of training to learn, use and interpret. CD-CARD requires no expensive instruments and gives a diagnostic result within 10 minutes. The speed, low-price point and simplicity of CD-CARD make it an attractive solution in any setting; be it a sophisticated Western Hospital, a rural clinic in Sub-Saharan Africa or a resource-limited settings in an emerging economy such as India.

Measuring the number of CD4+ cells in blood is an effective way of monitoring the effect of treatment in HIV infected patients and leads to improved prognosis for the patient. The standard method for doing this is flow cytometry (cell counting). However, flow cytometry requires specialist laboratories/staff and is expensive, and may patients especially in middle/low income countries do not have access to this technology. The test developed in this project would allow for near patient monitoring, and is faster and less expensive than flow cytometry. This is significance to many HIV infected patients and health providers. For the involved companies, the development of the CD-CARD led to increased knowledge on developing a Point of Care device, has strengthened the links between both companies and with important distributors and manufacturers.

BACKGROUND: There were 36.9 million people living with HIV in 2014 and 2 million new HIV infections each year. The life expectancy of HIV and AIDS patients has improved during recent years. The result is increased demand for active monitoring and identification of new cases. To meet the increasing patient load new diagnostic tools are required, which are reasonably priced and easy to use. CD4 and CD8 cell counts are of central importance in the monitoring of immune function. Current recommendations for HIV recommend a CD4 test every 3-6 months for the patient's lifetime. (WHO Fact sheet #360, July 2015). STATE OF THE ART: Flow cytometry is used to make CD4 counts in industrialised countries but is not available in emerging economies and resource-limited settings. New point-of-care methods are available but these have limited capacity and test prices are high. CD-CARD - A NEW INNOVATIVE CELL COUNTING TECHNOLOGY: CD-CARD (Cluster Differentiation Card) technology is applicable to any protein cluster that makes up a cell surface receptor. There are many different types of protein clusters, but CD4 and CD8 are those that are important in HIV and AIDS patients. CD-CARD gives results within 10 minutes, which means blood sampling, diagnosis and follow-up treatment are performed on the same visit. CD-CARD requires a minimum of training to learn, use and interpret. CD-CARD IS DIFFERENT:  CD-CARD is not an instrument but a low-priced test card. CD-CARD makes CD4 counts in clinical settings and in the field. It gives a result in under 10 minutes, and is low-priced, robust and easy to use. R&D CHALLENGES: 1. Hindering interfering monocytes from reaching the detection field on the test card. 2. Development of colored reagents for quantitative measurement of CD4 and CD8. 3. Measurement of color intensity by simple means to make quantitative measurements. 4. Transferring CD-CARD technology to mass production.