In-vitro diagnostics in need of standards
Born from a merger between Japan-based Sysmex and Germany-based Partec, the firm says harmonization will foster standards in Nigeria’s rapidly growing market for in-vitro diagnostics (glass-based work in laboratories for testing) with the official presence of its Nigeria office. Torsten Reinecke, Sysmex vice president of commercial affairs, Eric Osei, its general manager for West and […]
Born from a merger between Japan-based Sysmex and Germany-based Partec, the firm says harmonization will foster standards in Nigeria’s rapidly growing market for in-vitro diagnostics (glass-based work in laboratories for testing) with the official presence of its Nigeria office. Torsten Reinecke, Sysmex vice president of commercial affairs, Eric Osei, its general manager for West and Central Africa, and Annie Abimiku from its Nigeria office, spoke with Daily Trust.
Where exactly does Partec fit in the Nigerian IVD market?
Reinecke: The main focus of Partec is HIV, malaria and tuberculosis in Africa. Partec offers in-vitro diagnostic devices for these three diseases. This is quite challenging, because in Africa you have to have solutions which fit the African need.
Do you see these products as actually fitting, considering issues as power supply and maintenance?
Reinecke: The solutions which Partec offer have battery power capacity. We offer point-of-care, near-patient testing devices which can be in remote places even without power supply there. Cyscopes, which are specialized microscopes for TB and malaria detection and screening, with little handdriven power generator for the lamp you need for microscopy. That’s how we focus on the requirements that are especially not in the major hospitals in the capital but in remote places, where you have to bring the diagnostic tool to the patient.
How different are these cyscopes from present imaging technology used for TB detection in Nigeria?
Reinecke: Cyscopes offer fluorescent microscopy. They are specific for the microbes. It can be used by anyone with a little training who is used to laboratory work.
And the training?
Reinecke: The technology used in first flow cytometry for HIV diagnostic. It is quite sophisticated but the use is very easy, and meantime between failures of this device is far beyond one year. But if you follow the maintenance the manufacturer require, it is quasi maintenance free. There is no specific training required to maintain these analysers.
What’s the biggest challenge you face in filling the niche of the in-vitro diagnostic market in Nigeria?
Osei: It is being able to get clients to understand our service structure to make sure we don’t have breakdown of these equipment. With this, we are sure our service structure will be one of the best in Africa.
What’s your sense of how the maintenance of these biomedical equipment works out?
Osei: We haven’t done badly with the [nongovernment organizations] because we always have complete service contract in terms of equipment. What we are doing now is to localize this service contract with our local distributors, build capacity of our local people and our customers to be able to handle these equipment once they break down.
You are dropping shipment of controls, bypassing Germany and going straight through the US. Doing that, you say, could increase shelf life of control samples. Has that being a major problem?
Osei: It has been a very, very tipping problem in Nigeria, because the controls have a very short shelf life—and if the shipment should take longer, we have a problem where the control arrives and by the time they get to the end user site, let’s say, in the north, they already have it close to expiring. We realized this was a need with most of the NGOs and we decided to have controls shipped directly from the US.
And that will take how many weeks off the shipping time?
Osei: We will gain about three weeks more on the shelf life. On the control, this is very, very important an extension.
How have regulations and policies benefitted you?
Osei: Nigeria has taken the lead in regulating IVD instrument, especially in our discussion with Standards Organisation of Nigeria, on reagents with NAFDAC, and we have also taken steps to join the harmonization programme of Medical Laboratory Science Council of Nigeria. This, we hope, will standardize equipment to, say, even two major options that everybody will be directed to use. And based on this, we can have a reference point for clinicians to know whether the results they have can be benchmarked with any other results from other institutions. There are more than 100 types of haematology analysers in Nigeria. With such a harmonization programme, we can reduce them to maybe top two quality.
And all those that don’t fit that benchmark will be weeded out?
Osei: And this is in the interest of the clinician and the patient, not in the interest of business. It is to make sure that all results are standardized. If you do a test for blood [haemoglobin] and you get a result of 14 at UCH and 12 at UATH, and both of them are using different equipment and different reagents, how do you know whether the results are right or not? This is what the harmonization will seek to bring—which products are collected, which protocols are acceptable, and which results range you can reference with.
How will this collaboration help the Nigerian IVD market?
Abimiku: Partec deals with HIV, TB, malaria. Sysmex is into haematology and urinalysis. Most times these are related. It is a fantastic cooperation that will help diagnostics and lab analysis in this country.
From the perspective as a supplier, how big is the diagnostics market in Nigeria?
Abimiku: We have a big one and one that can be much bigger, if we would provide services to some of the rural areas—and we have quite a number of them that still don’t have diagnostic services in our healthcare system. It is big now and I expect it will be even bigger when government decides to spend more on rural areas.