TROPONIN I (i-CHROMA)

- Fluorescence immunoassay
- Most sensitive and specific biochemical markers of myocardial necrosis
- Three types of troponin: Troponin-C, -I, -T (make cardiac muscles contract)
- Important in diagnosis of MI
- Normal concentration in healthy individuals is <1.5 ng/mL
- Also used in monitoring of post-treatment clinical status and post-therapeutic evaluation of patients
- Troponin values can remain high for one to two weeks after a heart attack. The test is not affected by
damage to other muscles, so injections, accidents, and drugs that can damage muscle do not affect
cardiac troponin levels. Troponin may rise following strenuous exercise, although in the absence
of signs and symptoms of heart disease, it is usually of no medical significance
- Increased troponin concentrations should not be used by themselves to diagnose or rule out a heart
attack (clinical history and ECG).
Principle: Based on an immunoassay system using antigen-antibody reaction and fluorescence
technology
Components and reagents:
Test strip: murine antibody against human Tn-I and streptavidin
Detection buffer:
o fluorescent-labeled anti-Tn-I antibody
o fluorescent biotin-labeled bovine serum albumin (BSA)
o bovine serum albumin (stabilizer)
o sodium azide in phosphate buffered saline (preservative)
Storage and stability: up to 20 months in 2-8
o
C
Procedure:
75L (buffer) + 75L (serum) add 75L of mixture to sample well incubate for 12 mins (RT)

Alpha Feto Protein (i-CHROMA)
- immunoassay measurement of AFP
- produced primarily in the lover of developing fetus
- also found in maternal blood and in amniotic fluid and secreted to fetal serum
- 15 ng/ml is found in healthy individuals
- Increased primarily in hepatocellular carcinoma and non-seminomatous testicular cancer
- Also increased in GIT cance, viral hepatitis, chronic active hepatitis, alcohol cirrhosis
Principle: based on fluorescence immunoassay technology; sandwich immunodetection method
NV: ~10.9 ng/mL (analytical sensitivity)
Component of reagents:
Test device: murine monoclonal ab against human AFP and Rabbit IgG have been immobilized
on the test and on the control line respectively
Detection buffer: anti-AFP antibody


TSH/thyrotropin (i-CHROMA)
- Measure of thyroid function
- Used to diagnose thyroid or pituitary disorders
- From anterior pituitary (produces T3 and T4 )
- Extremely low concentration in blood
- TRH and TSH levels are inversely proportional to the levels of thyroid hormones (negative
feedback mechanism)
Principle: sandwich immunodetection method
Reference range:
Gestation and childhood Adults
0 day 1.0-39.0 20-54 years 0.4-4.2
5 days 1.7-9.1 55-87 years 0.5-8.9
1 year 0.4-8.6 Pregnancy
2 years 0.4-7.6 1
st
trimester 0.3-4.5
3 years 0.3-6.7 2
nd
trimester 0.5-4.6
4-19 years 0.4-6.2 3
rd
trimester 0.8-5.2
Components of reagents:
Test device: mouse anti-TSH Ab (test line) and streptavidin (control line)
Detection buffer:
o fluorescent-labeled anti-TSH antibody
o fluorescent biotin-labeled bovine serum albumin (BSA)
o bovine serum albumin (stabilizer)
o sodium azide in phosphate buffered saline (preservative)
Procedure: 75L (buffer) + 150L (serum) 75L of mixture to sample well incubate for 12 mins (RT)

T4 / Thyroxine (i-CHROMA)
- fluorescence immunoassay
- 99% of it is reversibly bound to three plasma proteins in blood: thyroxine binding globulin
(TBG)(70%), thyroxine binding pre-albumin (TBPA)(20%), albumin (10%); 0.03% of T4 is free
- 0.03% of T4 is free
- Marker for diagnosis of hypothyroidism and hyperthyroidism
- Decreased in hypothyroidism, myxedema, and chronic thyroiditis
- Increased in Graves dse and Plummers dse
Principle: competitive immunodetection method
NV: euthyroidism: 60-120 nmol/L; Hyperthyroidism >140nmol/L; hypothyroidism <50nmol/L







Components:
Test device: BSA-labeled T4 (test)
Detection buffer:
o fluorescence-labeled anti-T4 antibody
o fluorescent biotin-labeled bovine serum albumin (BSA)
o bovine serum albumin (stabilizer)
o sodium azide in phosphate buffered saline (preservative)
Procedure: predispensed buffer + 10L (serum) 75L of mixture to sample well with in 10secs
incubate for 10 mins (RT)

HBsAg (SD BioLine)
- chromatographic qualitative immunoassay
- Hepatitis B is caused by HBV
- Immunochromatographic (rapid) test; radioimmunoassays; ELISA
Component:
Test region: mouse monoclonal anti-HBsAg pool
Control region: mouse monoclonal anti-chicken IgG
*test strip is pre-coated with .conjugated gold colloid
Storage: 1-40
o
C
Procedure: add 100L of serum incubate for 20 mins

ANTI-HBs (SD BioLine)
- chromatographic