Increasing access to anaemia testing
Challenge
The haemiglobincyanide (HiCN) reference method has been the gold standard for measuring haemoglobin concentrations in blood, indicative of anaemia, for more than 50 years. Used around the world to diagnose anaemia and monitor response to treatment, the HiCN method is both effective and benefits from readily-available stable calibration standards.
The method uses potassium cyanide as a reagent to release haemoglobin from red blood cells - a spectrophotometer can then be used to determine haemoglobin concentration from the optical density of the solution. However, the disposal of large volumes of reagent containing cyanide creates a potential toxic hazard, and, in some countries, cyanide reagents are no longer available. In this case, alternative methods must be used and no reference method is available.
New methods are needed which can measure haemoglobin levels without the use of toxic chemicals, in addition to being both costeffective and easy-to-use. One promising alternative uses a nontoxic alkaline haematin detergent (AHD) and similar spectrometers to those used in the HiCN method. However, a standardised test procedure linking AHD measurements to the SI units is needed before the method can become an internationally-accepted reference method for the diagnosis and management of anaemia.
Solution
The EMRP project Metrology for metalloproteins developed a reference material which links AHD measurements to the SI units for the first time. The project also developed an AHD measurement method protocol, which was tested in haematology laboratories to ensure its practicality. These results ensure that haemoglobin measurements produced by the test are reliable and comparable between users, and ultimately suitable for clinical use.
Impact
The German standards organisation DIN is revising its existing standard on reference methods for analysing blood samples (DIN 58931) to incorporate the AHD method developed by the project, supporting its recognition and use as an alternative to the HiCN method. DIN has also proposed that CEN undertake a new work item on reference methods for determining haemoglobin concentrations in blood, an important first step towards the AHD method’s inclusion in an international standard.
As part of the project, two reference laboratories, Instand e.V. and RfB (Reference Institute for Bioanalytics) were trained in the traceable AHD method and are implementing it in their laboratories. Both labs expect to provide benchmark values in the course of 2017 and conduct interlaboratory comparisons to ensure the quality of clinical results produced by labs using the AHD method.
The results of the project have removed major barriers preventing the AHD method from being internationally recognised as a reference method for the diagnosis of anaemia. When underpinned by international standards, the AHD method will be able to replace the HiCN reference method, removing the associated toxic waste stream and reducing the cost of anaemia diagnosis and management. This, in turn, will support timely treatment of this widespread condition, promoting personal health and increased productivity worldwide.
- Category
- EMRP,
- Health,