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Point of Care Haemoglobin Analysis

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EKF Diagnostics recently launched the new DiaSpect Tm, a reliable, accurate and easy to use Point of Care haemoglobin analyser.

We spoke to Katja Lemburg, Haematology Global Product Manager, EKF Diagnostics, to learn about some of the features that make the DiaSpect Tm particularly suited to Point of Care use, and hear some examples of its use in resource poor settings.

AM: Can you tell us a little about the DiaSpect Tm haemoglobin analyser?

KL: The DiaSpect Tm is a lightweight, hand-held analyser which provides results for diagnosis of anaemia in just one second. DiaSpect Tm is extremely robust since it has no moving parts and the disposable cuvettes are reagent free, and is therefore unaffected by heat and humidity. The DiaSpect Tm uses plexiglass microcuvettes which have a shelf life of 2.5 years and can be stored from 0-50°C, meaning that refrigeration is not necessary. (Short term storage is possible at -30°C - 70°C for a maximum of 24 hours). DiaSpect Tm also benefits from long battery life of 40 days continuous use or 10,000 tests.

AM: What features make the DiaSpect Tm especially suitable for Point of Care use? 

KL: The DiaSpect Tm has proved itself to be highly effective in challenging POCT conditions in many locations, including east Africa and south-east Asia. In such environments heat and humidity can affect the performance of a POCT device and, more importantly, the cuvettes used for blood collection. Crucially, the DiaSpect Tm is unaffected by these environmental factors due to its reagent-free disposable cuvettes, as well as the fact that it has no moving parts. Furthermore, with its extremely long battery life, this all ensures that this compact palm-sized device is ideal for use outside of laboratories, or in resource poor locations.

AM: How does the performance of DiaSpect Tm compare with other laboratory based haemoglobin tests?

KL: Point of Care Testing (POCT) devices can play a prominent role in improving global health, particularly in areas where readily available laboratory facilities are limited. In such instances the use of POCT analysers provides a practical solution. Many POCT devices fail because of high temperatures, humidity and inconsistent sources of electrical power. Therefore, any POCT device used for anaemia screening must be durable and robust, as well as consistently analytically accurate.

A study performed by the Ministry of Public Health and Sanitation (Nairobi, Kenya) confirmed that the DiaSpect Tm compares well with established methods of blood haemoglobin measurement, producing readings that correlate favourably with a standardised laboratory-based reference analyser (P >0.05). The study concluded that DiaSpect was simple, reliable, extremely rapid and accurate, making it suitable for POCT, particularly where laboratory facilities are limited.

AM: EKF’s analysers are used in over 100 countries. Can you give some examples of where the DiaSpect Tm is used in resource poor settings? What has feedback been like from users?

KL: Users in hot and humid climates like using DiaSpect Tm as they really benefit from the reagent free cuvettes. For example, in Indonesia DiaSpect Tm is proving to be highly effective where there is an extremely fragmented hospital service. This is due to the fact that the country is divided into 34 provinces, which are in turn subdivided into 511 Districts, 185 of which are classified as disadvantaged. Indonesia’s population is also immense; records in 2013 showed in excess of 248 million people, with over 5 million pregnant women. Consequently, meeting the WHO recommendations for anaemia testing of pregnant women at the beginning of their third trimester presents significant logistical challenges.

Health Centres in Indonesia’s peripheral areas traditionally use manual methods for haemoglobin testing, such as copper sulphate which can be inaccurate and generate environmentally hazardous waste. Alternatively, samples may be sent to central laboratories which present issues of transportation from remote areas and a delay in receipt of results. The use of DiaSpect Tm in Health Centres within Indonesia’s peripheral areas is very advantageous since it combines laboratory quality performance with an unmatched measurement speed of one second to result.

In addition to its accuracy of result, Health Centres like the ones in Indonesia, prefer using DiaSpect Tm as they find its long shelf-life, and its resilience to humid climates extremely advantageous. Also, crucial to use of POCT devices in remote areas, they find the DiaSpect Tm convenient, not just for transportation to other locations, but also due to its integrated rechargeable lithium-ion battery which can be charged with the USB cable through a PC or Laptop. Simplicity of use is also a key consideration in these settings. If time and resources available to train nurses is lacking, the DiaSpect Tm helps as it is factory-calibrated against the HiCN reference method in accordance with ICSH. It also requires no re-calibration or maintenance, since it undertakes an automatic self-check between every measurement.

AM: Any other aspects of DiaSpect that you wish to highlight?

KL: Its ‘always on’ technology also means the analyser is permanently ready for use. The user simply collects a capillary or venous blood sample of <10 μL into the microcuvette that is then directly inserted into the analyser where a result appears in one second. Finally, results can be downloaded to a PC via USB or Bluetooth.

For more information, please visit http://www.ekfdiagnostics.com/

Katja Lemburg was speaking to Anna-Marie MacDonald, Editor for Technology Networks.