BIO2215 - Clinical Biochemistry Assignment

Assignment Task

This assessment is a competency-based requirement, which requires each student to score 20/40 (i.e. 50% or more) to pass the assessment piece satisfactorily, as well as the course. You must attempt and submit all assessment items in order to pass the course, including this assessment item

The assignment needs to be in your own words. Failure to write in your own words may result in academic penalty. Please note that the usual expectations regarding academic integrity apply to this assessment. This is an individual assignment and should not be completed as group work. Be sure to act ethically and honestly in the completion of this assignment, using your own words and not coping from other students, class notes, or resources, and protecting your work from being copied or misused by others. Assessments will be submitted through Turnitin and any work that does not meet these guidelines will be referred for Academic Integrity review and may receive a score of zero.

Question

1. Method Evaluation and Validation

1. A rapid immunochromatographic test is commonly used to determine if someone is COVID positive. It is a qualitative test that detects the presence of viral antigen within the respiratory passage using a sample from the upper respiratory tract. Rapid immunochromatographic test is not as sensitive or specific as a laboratory-based nucleic acid amplification assay, such as a polymerase chain reaction (PCR) assay, which is the gold standard used to diagnose COVID. The following data was on community-based adult patients who had COVID symptoms. Calculate the sensitivity and specificity of a rapid immunochromatographic test for detecting virus. Determine the predictive value of the positive rapid immunochromatographic tests in this scenario. Show all the steps used to calculate this and explain the steps where possible/appropriate.

ii. During your residential school, you analysed glucose concentrations from 30 serum samples using a recently introduced reagent from the company ‘Aurora’. What would be your decision regarding using this new reagent in your laboratory for the routine analysis of glucose concentration. Provide supporting statements of how you arrived at this decision.

2. Quality Control

Glucose control values (mmol/L) for both high and normal controls are provided below for the last 20 days.

i. Calculate the mean and standard deviation from the above data set (separately for normal and high control data set) 

ii. Create a Levey-Jennings control chart (one graph for each level) from the data provided 

iii. You are working as a clinical biochemistry scientist in a multi-disciplinary laboratory in a regional hospital. You ran two glucose quality control samples and obtained the following values; normal control: 5.4 mmol/L and high control:mmol/L. Plot these control values on the Levey-Jennings charts you created for question (ii) and interpret these results. 

iv. You performed an internal quality control assay for albumin using two different control materials (Control 1 and Control 2) using spectrophotometry in the residential school. Based on the results obtained, determine the validity of the albumin assay. Give reasons to support your decision. 

3. Reference Interval

You were asked to verify a reference interval for a new analyte, X. The results are known to be different in men and women. The following results (mmol/L) were obtained from 40 men.

i. Graph the above data (frequency against values (concentration))

ii. Establish the distribution of the data (parametric or non-parametric) just by visualising the graph (question i). Explain your reasoning.

iii. Calculate the reference interval from this data using an appropriate method based on data distribution. Show all the steps of calculation and explain the steps where possible/appropriate.

4. Quality Control and Critical Results

While working as a multidisciplinary scientist in a regional hospital, you obtained a serum potassium level of 6.1 mmol/L from a 64-year-old patient. Explain in detail all the possible next steps you would undertake from here in this scenario.

5. Quality Control

Identify all the Westgard Multi-rule violations in the given QC chart for ethanol. The chart shows the quality control run for 30 days. Two level of controls (level 1: Low control and Level 3: high control) were run at least twice daily. 

6. Explain the following terminologies in your own words. Give examples where possible. The explanations need to demonstrate your understanding of the topic. 

i. Reagent blank

ii. Standard

iii. Analytical sensitivity vs lower limit of quantification

iv. Linearity

v. Calibration

7. Spectrophotometer

The absorbance of 80 g/L of an albumin standard was 0.70. The absorbance of a patient sample was 0.55. What is the concentration of albumin in the patient sample? Show all the steps of calculation and explain the steps where possible/appropriate.

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