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TECOtechnical BulletinThe determination of Hyaluronic Acid (HA) is useful:
Research in Joint Diseases IN RA and OA subjects, the concentration of HA correlates with the degree of joint inflammation and
synovial proliferation, as well as, with the degree of joint space narrowing. Therefore, serum HA
could be used to study degenerative joint disease.
Research in Liver Fibrosis and Cirrhosis Serum levels of HA are typically low in healthy research subjects as circulating HA is rapidly removed
from blood by sinusoidal cells (SECs) in the liver. Serum HA correlates with liver pathology,
particularly in cirrhosis, where the reduction in HA receptors resulting in an increase in circulating HA.
HA has been extensively studied in research with different aetiologies of liver diseases.
Lit.Overview: Subjects with different aetiologies – Performance of Hyaluronic Acid (HA)
Aetiology Diagnostic performance of HA Reference
Hepatitis C Virus (HCV) 100% NPV for cirrhosis Halfon P et al. 2005
Hepatitis B (HBV) 90% sensitivity, 98.1% specificity for extensive fibrosis
Montazeri G et al. 2005
Alcoholic Liver Disease (ALD) 82.6% sensitivity, 69% specificity for hepatic fibrosis, > Ludwig stage 2 ; continuous rising HA concentration during progress of liver damage
Stickel F et al. 2003
Non‐alcoholic Fatty Liver Disease (NAFLD)
85% sensitivity, 80% specificty for severe fibrosis
Suzuki A et al.2005
C282Y Hemochromatosis (HH) 100% sensitivity and specificity for cirrhosis
Crawford DHG et al. 2009
Diapharma Group, Inc. Distributor8948 Beckett Road West Chester, OH 45069 USA
ML-00-00197Rev01 TECO Hyaluronic Acid is for research use only in the U.S. and Canada
Data provided by Bantel, Medizinische Hochschule Hannover
Other application
HA is also important in diabetes research, as a tumor marker and in pulmonary
inflammation.
THE TECO® HYALURONIC ACID PLUS ELISA
Convenient Assay Design Sandwich ELISA with CE mark
3 incubation and 3 wash steps
Time to result approx. 3 hours
Sample stability
‐ Maximal 3 day at 2 – 8 °C
‐ Maximal 6 months at ‐20 °C
‐ Long time storage at ‐80 °C
Accurate and flexible
Standardized against Pharmacopeia European Reference Standard
High Precision: Intra‐assay CVs: 2.8% – 2.9% ; Inter‐assay CVs : 4.7% ‐ 6.5%
Dynamic assay range between 15 ‐ 1,000 ng/mL covers the normal range
Minimal Detection Concentration of 2.7 ng/mL
Suitable for serum, EDTA plasma and supernatants from cell culture
Validated for human, monkey, dog, rabbit, sheep, goat and pig
Crossreactivity to other species
Identical results between serum and EDTA plasma samples
Identical result with Corgenix Human HA ELISA (r = 0.99)
Comparison with WAKO Hyaluronic acid LT (r = 0.93)
ML-00-00197Rev01 TECO Hyaluronic Acid is for research use only in the U.S. and Canada
TECO®HA PLUS ELISA Reference values
Serum samples from 53 healthy individuals (16 to 79 years, mean 45.5 years) were tested. The mean hyaluronic acid concentration was 36.7 ± 23.5 ng/ml. Based on these values a cut‐off of 90 ng/ml has been defined.
Mean ng/ml SD ng/ml
Female Premenopausal 20.1 14.3
Postmenopausal 50.3 19.9
Male 42.6 24.6
Age dependency
Serum and EDTA Plasma samples
0
20
40
60
80
< 6 6‐12 >12
Hyaluronic Acid (ng/ml)
Age Range
A regression analysis for corresponding
plasma/serum samples gave the following
results:
Plasma value = 1.07 x serum value with a
correlation of r = 1.00.
Serum and EDTA samples give identical results
in the TECO®HA PLUS ELISA
TECO® HA PLUS Serum vs. EDTA
Plasma
ML-00-00197Rev01 TECO Hyaluronic Acid is for research use only in the U.S. and Canada
Samples from different species can be used Samples from different species were positively tested by dilution and spiking.
Animal
Recovery
Dilution %
Spiking %
Rabbit 110 86
Goat 92 101
Pig 120 87
Dog 109 81
Sheep 99 100
Monkey 104 88
The TECO® HA PLUS ELISA predominantly measures HA forms with MW>90 Different HA forms with different Molecular Weight were tested using the spiking recovery.
HA – Form Mean Recovery
MW 4 – 8 kDa 18%
MW 15 – 40 kDa 29%
MW 90 – 150 kDa 76%
MW > 950 kDa 132%
The TECO® HA PLUS ELISA recognizes different HA preparation Different HA preparations were tested using the spiking recovery
HA – Form Mean Recovery
Human HA, blood cord 64%
Chicken Coomb HA 122%
Pharmacopeia Europ. Ref. Std 111%
Order Information:
TECO® Hyaluronic Acid Plus ELISA CE Catalogue Number: TE1017‐2
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Diapharma Group, Inc. Distributor8948 Beckett RoadWest Chester, OH 45069USAphone 1 800 526 5224fax 513 860 [email protected]
ML-00-00197Rev01 TECO Hyaluronic Acid is for research use only in the U.S. and Canada