Rapid Robust & Reliable Hemoglobin Analysis in Any Clinical Location

Rapid and accurate hemoglobin analysis is crucial for clinical decision makers at the point-of-care (POC). The Diaspect Tm is a palm-sized hemoglobin analyzer that provides laboratory quality results within seconds, no matter where the test is carried out. SelectScience^® speaks to Katja Lemburg from EKF Diagnostics to learn more.

SS: Katja can you confirm your job role and responsibilities please?

KL: I work at EKF Diagnostics as Global Product Manager for the hematology product range, with a focus on our POC hemoglobin analyzers.

SS: Can you start by giving us an overview of the DiaSpect Tm Hemoglobin Analyzer?

KL: The DiaSpect Tm is a compact, hand-held hemoglobin analyzer using a unique broad spectrum photometry method with reagent-less cuvettes. The single use cuvettes require a small sample volume of less than 10 µl of whole blood drawn in by capillary action. The cuvettes are then inserted into the analyzer for the measurement of hemoglobin.

Inside the photometer, a white LED is flashed briefly and the light beam passes through the sample to a specially designed optical sensor. The sensor detects the absorbance of the blood sample at a broad wavelength range to get an overall picture of the absorbance spectrum. A patented light trap prevents scattered light from arriving at the sensor. This is essential in order to obtain accurate results when measuring non-hemolyzed blood.

The advantage of a broad spectra measurement – compared to a double wavelength measurement – is a higher specificity; in addition to this, the sensitivity to interferences is lower.

Based on this innovative technology the DiaSpect Tm features a high precision with a CV of <1% within run, and at the same time delivers results rapidly in about one second of measuring time.

The analyzer is factory-calibrated to the cyanmethemoglobin (HiCN) method, the most common reference method for POC hemoglobin analyzers. This ensures a high degree of traceability and correlation to standard hematology analyzers in the laboratory.

Fast, robust, easy to use

SS: What are the key features and benefits of this analyzer, and why is it a better choice than other systems on the market?

KL: In short, the DiaSpect Tm combines the speed, robustness and ease of use of a reagent-less hemoglobin analyzer with the highest degree of precision and accuracy.

The device delivers results in just 1-2 seconds, which is a clear benefit in situations where numerous patients need to be tested quickly, such as blood donation settings or in anemia screening programs.

The complete system, comprising of analyzer, single-use cuvettes and controls is perfectly adapted for use in challenging climate conditions. This is important considering that the problem of anemia, where hemoglobin is the most important test parameter, has the highest prevalence in developing and resource-poor countries which often have the most challenging climatic environments.

The reagent-less cuvettes are not affected by humidity and can be stored from 0° to 50°C. Even temperature ranges from -30 up to 70°C are permitted during transport for up to 24 hours.

The cuvettes can be used for the entire period of the stated shelf-life (2.5 years from production date), even after opening of the foil bag, and no dedicated attention needs to be given to store them carefully closed with desiccant. Other reagent-based POC analyzer cuvettes rapidly degrade through humidity and need to be consumed within three months of opening the packaging.The liquid controls to monitor the performance of system and operator have a long 60-day in-use stability at up to 35°C.

The DiaSpect Tm features a rechargeable battery that lasts for up to 40 days or 10,000 tests in mobile operation; this is the longest duration in the market. It can be used as a hand-held device and is always ready for use, as indicated by the large numerical display.

There are no moving parts that could lead to malfunction and no maintenance required apart from cleaning which can be done with standard commercial cleaning materials.

SS: In which clinical areas is the DiaSpect Tm routinely used?

KL: Anemia, defined as a condition in which the number of healthy red blood cells or the availability of hemoglobin falls below the physiological needs of the body, is a very common health problem and affects a variety of patients with different types of diseases or nutritional deficits. Thus, there are a wide range of possible test sites and users in clinics, hospitals or in field use. Testing hemoglobin is also a key parameter in the pre-qualification of blood donors.

The test is most commonly performed by nurses or phlebotomists from finger stick samples at the POC or in blood donation settings, though venous or arterial samples may be used as well.

SS: Where is the product available to purchase currently?

KL: The DiaSpect Tm analyzer is CE-marked and currently undergoing FDA submission in the USA. It is available for purchase in Europe and most other countries globally, depending on local registration of the product.

SS: Can you tell me about the DiaSpect SmartApp connectivity solution you’ve been working on?

KL: There is a growing interest in mobile management of medical data, especially from emerging and developing countries where other means of communication infrastructure are often lacking. There is also an increasing number of mobile healthcare services with need for rapid data communication and documentation.

EKF Diagnostics is currently investigating the use of a smart app in combination with our DiaSpect Tm analyzer. The app retrieves the hemoglobin result from the analyzer via its integrated Bluetooth® interface and allows further entries of data, for example patient ID, operator ID and observations which are linked to the result. The connected data can be transferred to a PC, central server or cloud-based solution, depending on the customers´ requirements and infrastructure.