Topic: blood gasses point of care devices

Topic: blood gasses point of care devices
Pages: 3, Double spaced
Sources: 5
Order type: Lab Report
Subject: Chemistry
Style: Vancouver
Language: English (U.K.)

I am working in an emergency department in a small regional hospital without on-site
Biochemistry Laboratory and my manager asked me to provide recommendations for the selection of an appropriate Point of care test device for Blood Gases tests.

You must find at least 5 different point of care test devices from different companies and compare these devices in 15 different criteria such as, type of sample, accuracy, size…etc. and you must write these information in excel sheet.

Then you must chose only one best device:
Provide justification for your choice of device:

To do this you will need to develop a selection criteria to compare the available devices. Then you will need to summarise your recommendations and consider any on-going operational procedures required in order to provide quality results for patient testing.

Include in your answer recommendations with regard to:

• Critical evaluation of testing devices which provide results appropriate to clinical requirements (i.e. is the chosen device fit for purpose ?)
• Pre-analytical considerations
o Instructions for patient preparation and sample collection
o Patient safety and risk management
o Operator handling & training required
• Analytical considerations
o Frequency and type of quality control (QC)
o External quality assessment (EQA) procedures
o Device maintenance requirements
• Post-analytical o Instructions for the recording / reporting of results
• Other general considerations for testing

Some background notes about this assignment:

For the successful completion of this exercise, you will need to think about all the aspects of testing for these analytes. This will include all of the quality specifications as well as the practical considerations such as user friendliness, cost, shelf-life of reagents, portability and so forth. (Note: This is what you would need to do in a work environment if you were asked to select a new instrument – be it lab or POCT). To do this you would first collate the data and include it in a spreadsheet for comparison. Then once your comparison and decision is made, you would write a brief report for your manager. Such a R. Greaves POCT Page 2 report is called an executive summary. This summary is only one page in length – this is because your manager is busy and just wants your conclusions with brief justifications.


Justification = Excel spread sheet: Develop a spreadsheet for your justification and embed it as a linked table in the word document). This spreadsheet should critically compare devices against your selection criteria.

Recommendations = Written (executive) summary: Provide a written summary justifying your recommendations. Make sure you justify your summary using the evidence from your Excel sheet. As this is an executive summary, your text should be no more than one page of writing with a word limit of 250 for the written text.

Referencing: Vancouver style. Place your relevant references at the bottom of your Excel sheet and just add the main references based on your decision to the word document.

Point of Care Testing (POCT)

Executive summary With significant advancement in health science related research, a number of technological devices are being developed, which have the health care diagnosis easier and faster. Point of care devices are becoming very useful in rapid diagnosis, as the tests are done in easy processes within very short time and the devices gives accurate results, thereby stimulating the medical interventions (5). In this assignment, the focus is to compare the point of care devices (PCOT) developed for easy diagnosis of creatinine and troponin. Create inine test Creatinine is a pivotal biomarker and it has a very important contribution in the diagnosis of kidney disease, because, due to malfunctioning of kidney, the filtration is impaired and the level of creatinine in blood increases (4). In this assignment, four point of care devices have been compared, these are i-STAT, ABL 800 Flex, Reflotron and Nova Starsensor.  i-STAT and Nova Starsensor, both are developed by USA based companies and requires whole blood as a sample, which is more available. However, ABL 800 Flex and Reflotron include whole blood, plasma or serum as sample (9). Therefore, the last two devices are more diverse, considering the sample type. In case of sample volume, ABL 800 Flex requires the highest amount, 250μl and Nova Starsensor requires the least amount, 1.2μl (6). Nova Starsensor also shows the best characteristics, based on time of sample analysis; it requires only 30 seconds showing the result. All the devices have approval from FDA. Two USA based devices are lightweight, compared to other two devices. All the devices follow enzymatic method of sample measurement. The range of detection is higher in ABL 800 Flex (10-2000 µmol/L). Except Reflotron, all three devices use Amperometric biosensor, as a method of principle; it has high sensitivity compared to Dye Reflectance. Nova Starsensor has the least weight within these four (400 gram), making it the best choice for the patient to carry the device anywhere (8). Therefore, based on the above criteria, usability and availability of sample, the Nova Starsensor is recommended as the best point of care device for creatinine test. Troponin test Troponin is a significant biomarker, which helps in diagnosis of heart attack, because, during myocardial infarction, the damaged heart muscle induces the release of this biomarker in blood, thereby elevating its level in blood. As heart attack needs immediate diagnosis, several point of care devices are used for easy and faster diagnosis, within which four devices, Triage Cardiac Panel Troponin I, i-STAT cardiac troponin I, PATHFAST troponin I and RAMP  troponin I has been compared in this assignment (1).  Within the above four devices, all devices required whole blood sample, but instead of i-STAT cardiac troponin I, other devices requires heparinized or EDTA whole blood, therefore, the sample cannot be tested directly, through these devices, however, a patient undergoing a heart attack needs immediate diagnosis, thus, i-STAT cardiac troponin I would be a good choice (7). On the other hand, compared to the Triage cardiac panel troponin I, other three devices can be used in room temperature. However, the i-STAT device has the lowest weight and required the lowest volume of sample (16 μL), compared to the other three devices. The analysis time is also minimum for this device (10 minutes), within these four devices; thus, it is more user-friendly, compared to others (2). In Triage cardiac panel troponin I and RAMP troponin I, chromatography is used as the principle of method, whereas, i-STAT uses ELISA and PATHFAST troponin I uses magnetic beads. ELISA is the most relevant, hazard free and fast technique within the above three principles. Thus, based on the above comparison, i-STAT cardiac troponin I is recommended as the best point of care device for troponin test (3). 
Reference List1. Bingisser R, Cairns C, Christ M, Hausfater P, Lindahl B, Mair J, Panteghini M, Price C, Venge P. Cardiac troponin: a critical review of the case for point-of-care testing in the ED. The American journal of emergency medicine. 2012 Oct 31;30(8):1639-49.2. Chan CP, Mak WC, Cheung KY, Sin KK, Yu CM, Rainer TH, Renneberg R. Evidence-based point-of-care diagnostics: current status and emerging technologies. Annual review of analytical chemistry. 2013 Jun 12;6:191-211.3. Diercks DB, Peacock WF, Hollander JE, Singer AJ, Birkhahn R, Shapiro N, Glynn T, Nowack R, Safdar B, Miller CD, Lewandrowski E. Diagnostic accuracy of a point-of-care troponin I assay for acute myocardial infarction within 3 hours after presentation in early presenters to the emergency department with chest pain. American heart journal. 2012 Jan 31;163(1):74-80.4. Lee-Lewandrowski E, Chang C, Gregory K, Lewandrowski K. Evaluation of rapid point-of-care creatinine testing in the radiology service of a large academic medical center: impact on clinical operations and patient disposition. Clinica Chimica Acta. 2012 Jan 18;413(1):88-92.5. Pecoraro V, Germagnoli L, Banfi G. Point-of-care testing: where is the evidence? A systematic survey. Clinical chemistry and laboratory medicine. 2014 Mar 1;52(3):313-24.6. Pollock NR, Rolland JP, Kumar S, Beattie PD, Jain S, Noubary F, Wong VL, Pohlmann RA, Ryan US, Whitesides GM. A paper-based multiplexed transaminase test for low-cost, point-of-care liver function testing. Science translational medicine. 2012 Sep 19;4(152):152ra129-.7. Qureshi A, Gurbuz Y, Niazi JH. Biosensors for cardiac biomarkers detection: A review. Sensors and Actuators B: Chemical. 2012 Sep 30;171:62-76.8. Skurup A, Kristensen T, Wennecke G. New creatinine sensor for point-of-care testing of creatinine meets the National Kidney Disease Education Program guidelines. Clinical chemistry and laboratory medicine. 2008 Jan 1;46(1):3-8.9. Vashist SK, Luppa PB, Yeo LY, Ozcan A, Luong JH. Emerging technologies for next-generation point-of-care testing. Trends in biotechnology. 2015 Nov 30;33(11):692-705.