Homogenous versus Heterogenous NGAL Testing

In the public chatroom Ann asked a very good question:

User Ann: “Could you please elaborate a little bit on the technical difference between the homogeneous and heterogeneous NGAL test? Is it just a matter of marketing or is there a real technical difference in the product?”

I’ve taken the liberty to piece together the answers from Ndrs and me – and added a little extra:

On their website BioPorto informs about  the NGAL Test: “The NGAL Test is based on turbidimetry and can be used in a variety of automated clinical chemistry analyzers. Turbidimetry is simple, fast and accurat and meet a great demand for rapid NGAL measurements in both urine and plasma.”

What is turbidimetry you might ask (at least I did ask myself that)  well – it’s  measurement of the turbidity (cloudiness) of a solution or suspension in which the amount of transmitted light is quantified with a spectrophotometer or estimated by visual comparison with solutions of known turbidity.

The homogenous test in other words: (a simplified version) –  a homogenous test is a 1-step test, that measures the amount of light that passes through a spectrophotometer, and the heterogenous test requires 2-step (separation) where you have bind the marker to a given substance before you can determine the result..

In addition you have to develop at heterogenous test to each and every different type of machinery – whereas the homogenous can (in principle) be used on all types  BioPorto told us that the one-step test was faster and more precise

Basically – the heterogenous test is easier to develop but requires more than one ‘analysis-step’ And can only be used on the apparatus it’s developed on.

The homogenous test only requires one ‘analysis-step’ and does not depend on which apparatus it’s used on as such. Hospital central laboratories usually performs most homogenous test

Tests for fully automated systems explained: There are two basic types of test in fully automated systems, homogeneous and heterogeneous. BioPorto’s NGAL test is homogeneous,  it can readily be adapted to the systems that are supplied by the vast majority of manufacturers of automated analytical platforms. In contrast, a heterogeneous test depends on a separation step (as explained above), which in practice means that a particular test is developed for a particular system and cannot be transferred to another heterogeneous system.

As an example : Abbott Laboratories have  a heterogeneous NGAL test  that can only be used on their Architect systems.

When BioPorto decided to change strategy in 2009 (and bring the NGAL test to the market themselves) it meant that instead of relying and focusing on license-deals  they wanted to be able to control more f the process. Untill then – Bioporto were at the mercy of the companies that had licensed their product – now its more push than pull….  As they stated in 2009 – quote:

” BioPorto´s  homogeneous NGAL test is aimed at central hospital laboratories. In this way it  opens up the NGAL market to most of the major suppliers of analytical systems such as Roche, Siemens, Olympus and others. The NGAL test can be offered as part of the companies´ portfolio of specific tests that are available on their equipment.”

It has been BioPorto wish to establish supply agreements with the major existing suppliers of homogeneous NGAL tests for their own fully automated systems, so that this large market sector will be covered as widely as possible.

We have yet to see the first distribution agreement with a large supplier (although BioPorto openly and repeatedly stated that they expected such at an earlier stage) here is a recent quote from Q3 2011

“BioPorto’s sales strategy for The NGAL TestTM is based on establishing sales channels via global diagnostics companies marketing their own analyzers and by building up a network of distributors which market The NGAL TestTM at the national level.The establishment of distribution partnerships with several global diagnostic companies which market their own analyzers remains the object of negotiation, and validation of The NGAL TestTM on their specific analyzers is in progress. It is anticipated that the first agreement will be entered into in first half year of 2012.

The efforts of the past twelve months to establish national and international distributors has lead to The NGAL TestTM now being marketed in more than 22 markets, including Germany, the UK, France, Italy, Spain, Canada and India. This distribution network is expected to be fully developed in 2012. In November, BioPorto held its first “The NGAL TestTM Forum”, an all-day meeting organized for BioPorto’s distributors of the new kidney injury test. “