HemoCue Hb 201 Data Management System
The HemoCue Hb 201 DM system allows for simple data management in point-of-care blood testing for Hb and anemia screening.
The HemoCue Hb 201 DM system is a data management solution for hemoglobin testing and anemia screening. It is a way to manage patient information as it has QC lockout and barcode scanning for patient ID. The HemoCue system can be linked with existing systems using POCT-1A (Point of Care Testing standards).
Goal 3: Good health and well-being
Hemocue’s target users are medical professionals (nurses, doctors, local healthcare workers, laboratory technologists and technicians, microbiologists, and Healthcare researchers).
The product is mass-produced by HemoCue, headquartered in Sweden.
Patent: The microcuvettes used with the system are patented. Hemocue patent information can be found on their website.
The distribution to date is unknown.
A blood sample is collected in a HemoCue microcuvette which is placed in the device. The user then follows the steps on the screen to run the test. The specification of the operation can be found in this manual.
To purchase replacement components the user should contact their local distributor.
- Factory calibrated against the ICSH reference method
- Results within 60 seconds
- Results Storage: 4,000 patient/STAT tests, 500 QC tests, 500 analyzer logs, 200 patient IDs
- Reduced transcription errors
- Wireless connection capabilities
- Lab quality accuracy
This product correctly classified patients’ anemic status in 80% or more of instances. The HemoCue® gravity method was found to be more accurate than the HemoCue® wicking method.
Testing was done by HemoCue, Center for Biologics Evaluation & Research (CBER), and the US Food and Drug Administration (FDA)
There is a risk of inaccurate results if the storage instructions are not followed.
The HemoCue Hb system can be connected with existing systems as it complies with the Point of Care Connectivity standard. The system has bidirectional communication with middleware applications such as RALS, AegisPOC, & Telcor.
Sanchis-Gomar, F., Cortell-Ballester, J., Pareja-Galeano, H., Banfi, G. and Lippi, G., 2012, Hemoglobin Point-of-Care Testing, Journal of Laboratory Automation, 18(3), pp. 198–205.
Parker, M., Han, Z., Abu-Haydar, E., Matsiko, E., Iyakaremye, D., Tuyisenge, L., Margaret, A. and Lyambabaje, A., 2018, An Evaluation of Hemoglobin Measurement Tools and their Accuracy and Reliability when Screening for Child Anemia in Rwanda: A Randomized Study, Plos One, 3(1).
Gwetu, T.P. and Chhagan, M.K., 2015, Evaluation of the Diagnostic Accuracy of the HemoCue Device for Detecting Anaemia in Healthy School- Aged Children in KwaZulu-Natal, South Africa, South African Medical Journal, 105(7), p. 596.
Levy, T.S., Méndez-Gómez-Humarán, I., Ruán, M.D.C.M., Tapia, B.M., Hernández, S.V. and Ávila, M.H., 2017, Validation of Masimo Pronto 7 and HemoCue 201 for Hemoglobin Determination in Children From 1 to 5 years of Age, Plos One, 12(2).
Marwick, P.C., Johnson, M., Coetzee, J.F., Levin, A.I., 2016, Abstract PR612: Hemocue® Haemoglobin Concentration Measurements are More Accurate than those of Blood Gas Analysers and Assist in Avoiding Incorrect Transfusion Decisions, Anesthesia & Analgesia, 123, pp. 779–780.
The HemoCue 201 Hb DM system is FDA approved. It complies with the 7-71 CLSI H15-A3 (Replaces H15-A2) standard for Quantitative Determination of Hemoglobin in Blood.
The HemoCue 201 Hb DM system and the HemoCue 201 Microcuvettes has a CE – Mark. The HemoCueHb 201 Microcuvettes comply with the IVD Medical Device Direc-tive 98/79/EC and carry the CE mark. This, therefore, means that the product is approved for use in the European community.
A premarket evaluation was done by the Center for Biologics Evaluation & Research (CBER).
Evaluation methods involved comparing the results of HemoCue blood tests to laboratory results for the same patients.
In another research by Back et al.
- Between 119 and 138 samples were analyzed at 4 different hospitals
- Correlation for all systems against the reference method was better than 0.99
- Correlations between the new Hb 201+ and ADVIA 120 (Bayer Diagnostics), GEN-S (Beckman Coulter), Sysmex XE 2100, CellDyn 4000 (Abbott), and the HemoCue B-Hemoglobin system showed all r > 0.99.
- The Hb 201+ system yields results that agreed well with comparative systems.
- The system achieved accuracy and precision similar to the available cell counters.
In 2011 the system was recalled for 3 months due to a programming error.
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