Reference no: EM133958689

Clinical Biochemistry

Part A: To be submitted on Day 1 and Day 2 of the residential school

Activity 1: Each student will perform an internal quality control assay for albumin using two different control materials (Control 1 and Control 2) provided to them. Students will plot the values on L-J charts (L-J chart 1 for Control 1 and L-J chart 2 for Control 2) and determine if the controls can be accepted by referring to the Westgard Multirules.

Activity 2: Students will be provided with a unique synthetic sample to analyse the concentration of glucose. Each student will use a spectrophotometer to analyse the sample and calculate the glucose concentration using Beer's Law.

Part B: To be submitted via StudyDesk

Question 3: Method Evaluation and Validation

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 definitive diagnosis for 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 all the steps where possible/appropriate.

Definitive Diagnosis based on            Positive rapid immunochromatographic test        Negative rapid immunochromatographic test                
PCR test 
Yes                                                                       44                                                                       6
No                                                                         8                                                                      152

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.

Question 4: Quality Control
Glucose control values (mmol/L) for both high and normal controls are provided below for the last 20 days.

Day Normal control High control
1 5.0 10.0
2 5.3 10.2
3 4.8 9.8
4 5.1 10.1
5 4.8 9.8
6 4.7 10.2

7 5.4 9.9
8 5.0 10.1
9 5.2 10.0
10 5.3 9.9
11 4.9 10.2
12 5.0 10.3
13 4.8 9.9
14 5.1 10.2
15 5.4 10.1
16 4.9 10.1
17 5.0 10.0
18 5.4 9.8
19 4.8 10.0
20 5.1 9.9

Calculate the mean and standard deviation from the above data set (separately for normal and high control data set)
Create a Levey-Jennings control chart (one graph for each level) from the data provided
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: 9.4 mmol/L. Plot these control values on the Levey-Jennings charts you created for question (ii) and interpret these results.

Question 5: Reference Interval (Lecture 3)
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. Get AI-free online assignment help from experienced academic experts.

106 111 104 106 112
110 115 127 83 110
83 119 108 109 105
106 108 114 120 100
107 110 109 102 115
106 112 103 107 111
113 118 123 99 109
109 114 112 110 110

Graph the above data (frequency against values (concentration))
Establish the distribution of the data (parametric or non-parametric) just by visualising the graph (question i). Explain your reasoning.
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.

Question 6: Explain the following terminologies in your own words. Give examples where possible. The explanations need to demonstrate your understanding of the topic.
Reagent blank
Standard
Analytical sensitivity vs lower limit of quantification
Linearity
Calibration

Question 7: 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.