E!10253 Diagnostic product for patient testing

CD-CARD Forventet levetid for HIV og AIDS-pasienter har økt de siste årene. For å møte den økende pasientbelastning er nye diagnostiske verktøy nødvendig; som er raske, rimelige og enkle å bruke. CD-CARD er en ny oppfinnelse som måler to viktige parametre for overvåking av HIV- og AIDS-pasienter - CD4 og CD8 målinger. Kortet gir resultater i løpet av 10 minutter, noe som betyr at blodprøvetaking; diagnostisering og oppfølgende behandling er utført i samme besøk. I de vestlige og industrialiserte økonomier er CD4 og CD8 målinger utført ved hjelp av kostbar strømningscytometre ved sentrale laboratorier. I de ikke-industrialiserte og fremvoksende økonomier blir Point-of-Care instrumenter den foretrukke plattform. UNITAID - en WHO organisasjon som arbeider for å utrydde HIV / AIDS, malaria og tuberkulose - gir følgende kommentarer om CD4 og CD8 i HIV-relatert behandling. "... oppskalering av CD4-testing er nødvendig. POC teknologi gjør det mulig å utvide tilgangen til CD4 testing for pasienter i utilgjengelige områder, og returnere resultatene til pasientene samme dag som testing blir foretatt. Mulighetene for lavere priser er avhengig av nye teknologier, for eksempel engangs CD4 tester, som nærme seg US $ 3 per test, og uten behov for investering i instrumenter." CD-CARD er et engangskort, utviklet for masseproduksjon og bruk av svært sensitive reagenser. Kortet krever et minimum av trening for å lære, bruke og tolke. CD-CARD krever ingen dyre instrumenter og gir et diagnostisk resultat innen 10 minutter. Hastighet, lav pris og enkelhet gjør CD-CARD til en attraktiv løsning i enhver situasjon; det være seg et sofistikert vestlig sykehus, en lokal klinikk sør for Sahara eller et ressurs-begrenset legesenter i en fremvoksende økonomi som for eksempel 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.