HELGE™

POINT OF CARE HEMOLYSIS DETECTION

What is HELGE™?

HELGE™ is a simple, single use test for hemolysis point of care detection. Hemolysis, or the rupturing of red blood cells, is the most common reason for blood samples to be deemed unfit for analysis. When a blood sample cannot be analyzed, it causes diagnosis and treatment to be delayed, and increases risks for patients as well as costs for health care providers. HELGE™ is a point of care test used directly on the blood sample without affecting or altering it. Within 30 seconds, HELGE™ establishes whether

the blood sample needs to be re-taken, or if it is of high enough quality to be sent for analysis at a laboratory. HELGE™ consists of a needle that penetrates the test tube cap. A small amount of whole blood enters the test and plasma is separated. The separated plasma is transferred to a detection field. An easy-to-read display window changes color when hemolysis is detected. HELGE™ has a needle shield to protect the operator.

Each year, about 45 million blood samples globally are not eligible for analysis due to hemolysis.

HELGE’s accuracy has been proven in a clinical setting. A method comparison was carried out at the Department of Clinical Chemistry at the Central Hospital in Karlstad. The study tested 446 blood samples. Each of the samples were tested with both HELGE™ and a current laboratory standard test. Download the poster with the results here. To summarize the findings, the novel hemolysis point of care test, HELGE™, identified 82% (41 of 50) of the hemolyzed samples (sensitivity) and 96% (380 of a total of 396) of the non-hemolyzed samples (specificity).

THE DISPLAY WINDOW SHOWS THREE COLOURS

  • Yellow: Neutral or not in use.
  • Pink: No hemolysis. The display window turns pink when HELGE™ is activated. It stays pink if there is a low grade / no hemolysis, and the sample can be sent for analysis.
  • Blue: Hemolysis. The display changes to blue if the sample is hemolyzed.

Technical description

When activated, HELGE™ is placed with the display window face-down on the sampling trolley. The blood sample is turned, cap downwards, and pressed onto the needle inside HELGE™, which pierces the cap’s rubber seal (the septum), and blood is dispensed from the blood sample. HELGE™ and the test tube are then turned back so that the display window becomes visible to the operator/nurse.

References

M. J. Hallworth, ”The 70% claim: what is the evidence base?,” Annals of Clinical Biochemistry, vol. 48, pp. 487 -488, 2011.

P. Bonini, M. Plebani, F. Ceriotti and F. Rubboli, ”Errors in Laboratory Medicine,” Clinical Chemistry, vol. 48, no. 5, pp. 691-698, 2002.

P. Carraro and M. Plebani, ”Errors in a Stat Laboratory: Types and Frequencies 10 Years Later,” Clinical Chemistry, vol. 53, no. 7, pp. 1338-1342, 2007.

R. Mozzi, A. Carnevale, C. Valente, A. Dolci and M. Panteghini, ”Recording, monitoring, and managing pre-analytical issues in a metropolitan university hospital,” Biochimica Clinica, vol. 37, no. 2, pp. 95-99, 2013.

G. Lippi, N. Blanckaert, P. Bonini, S. Green, S. Kitchen, V. Palicka, A. J. Vassault and M. Plebani, ”Haemolysis: an over view of the leading cause of unsuitable specimens in clinical laboratories,” Clin Chem Lab Med, vol. 46, no. 6, pp. 764 -772, 2008.

G. Lippi and G. C. Guidi, ”Risk management in the preanalytical phase of laboratory testing,” Clin Chem Lab Med, vol. 45, no . 6, pp. 720-727, 2007.

Worlds Health Organistation, ”Use of Anticoagulants in Diagnostic Laboratory Investigations,” Worlds Health Organistation, Ge neva, 2002.