How a piece of construction paper led to a revolution in HIV diagnostics

Plasma Separation Card

Worldwide, only around 70 percent of patients infected with HIV are aware that they are even carrying the virus and less have the virus under control. This fatal information deficit is particularly widespread in the developing nations of Africa, where poor infrastructure seriously restricts access to reliable diagnostics. The cobas® Plasma Separation Card could make a real and lasting change to improving viral suppression. It is the product of courage and of passionate collaboration.

Kids in Afrika

"Doing now what patients need next" – when Elmar Jentzsch, Operations Project Lead, was asked to take on an additional task, he had no idea that it would end up bringing the Roche mission statement sharply into focus. "With the cobas® Plasma Separation Card, the reality soon became very tangible that millions of people could benefit from one of our products – that's an amazing feeling", he says.

Landscape in Malawi

These millions of people live in the less developed parts of Africa – in rural regions where there are no laboratories, hospitals or even paved roads. And they carry the human immunodeficiency virus (HIV), which requires intensive treatment. But how can doctors control a disease that they cannot adequately diagnose because of the poor infrastructure available to them?

LKW bei Wasserpassage

In Africa, blood samples often have to travel extremely long distances to reach the nearest lab. The combination of extreme heat and high humidity during transport has an adverse effect on the samples, usually rendering them unusable by the time they arrive at their destination. The next problem to contend with is that, following blood collection, the blood plasma required for HIV testing cannot be separated on-site.

Eine Karte aus Papier

Hand-crafted in California

That's how things stood back in spring of 2015, when colleagues in the Manufacturing Service & Technology unit on Mannheim's high-tech campus received a parcel in the post from Pleasanton, California. Inside they found something the size of a credit card, made of various layers of paper. Their colleagues in Roche Molecular Diagnostics had quite literally crafted a prototype from construction paper for an idea that could solve one of the biggest problems in African HIV diagnostics.

PSC-Produktionsanlage

The idea came from the thought that surely it must be possible to fully automate production of a kind of super-sized test strip – a transport medium that could separate plasma from whole blood, which could even be used in underdeveloped countries and, thanks to clever manufacturing, would be capable of withstanding the toughest conditions there.

Blutentnahme am Finger

Two years later, these very properties have been brought together in the cobas® Plasma Separation Card. This innovation renders venous blood collection every bit as superfluous as a centrifuge or similar equipment. A tiny finger-prick is all it takes to collect the blood on the cobas® Plasma Separation Card, where the plasma is separated and rendered suitable for transport.

Straßenkurve

And transport is no longer a problem either. The card stabilises the dried plasma so that it can endure extreme heat and humidity. It is also the only instrument for blood plasma sample collection that meets the World Health Organisation's sensitivity standard for determining viral load. This means that doctors could, for example, treat an expectant mother with AIDS so that her child will not contract the virus at birth.

Roche Mannheim

Cooperation: The key to success

The road to breakthroughs like this is usually a long one. In October 2015, it led Ronald Hofstadt, Andreas Trapp and their colleagues in the Manufacturing Service & Technology unit to their colleagues in Production, and Elmar Jentzsch was named Operations Product Lead. After all, once this project reached the banks of the Altrhein in Mannheim, a steady hand at the tiller was needed to coordinate purchasing and suppliers, calculate manufacturing costs and, of course, keep in contact with both Pleasanton and Rotkreuz.

Zusammenarbeit

"The only reason we were able to get the cobas® Plasma Separation Card market-ready in just two years was the incredibly close collaboration involved – with Rotkreuz and Pleasanton and, above all, on the high-tech campus in Mannheim itself", says Elmar Jentzsch. Colleagues from various areas at the site worked closely together to make valuable contributions to the development of the card. They cooperated on everything from design of the equipment, to the development of a new analysis method for determining the correct quantity of plasma stabiliser on the card, right the way through to providing advice on technical questions relating to the primary packaging. The project is a prime example of how a product like the cobas® Plasma Separation Card can be created within a short space of time when expertise is shared.

Leuchtturm

A lighthouse project in diagnostics

Not only has the cobas® Plasma Separation Card enjoyed a meteoric rise to become an important component of the Roche's Group's Global Access Programme, it has also become a global lighthouse project for diagnostics A project that is powered by a good measure of courage, passion and a "can-do" attitude.

Gruppenbild PSC-Team

"Once I've come to the end of my working life, I can hardly imagine a project I could be prouder of than the cobas® Plasma Separation Card", says Elmar Jentzsch. But who knows what other big ideas will come from Roche employees being creative!

To Roche Diagnostics*