Immunochemistry - Turbidimetric Immunoassay Reagents

IgY(ΔFc) Antibody-based Turbidimetric Immunoassays (TIA) and Latex-Enhanced Immunoturbidimetric Assays (LETIA or LTIA)

The diagnostic reagents Good Biotech Corp. manufactures and offers in the field of in-vitro diagnostics include turbidimetric immunoassays (TIA) and latex-enhanced immunoturbidimetric assays (LETIA or LTIA). Manufacturing duck antibodies is the leading-edge technique solely owned by Good Biotech Corp.; duck IgY(ΔFc) antibody, undoubtedly, is used as the major component of the Good Biotech Corp.'s immunochemistry assay kits. TIA is a well-established technique for the rapid quantification of analytes based on antigen-antibody reaction. The measurable range for TIA may be extended by amplifying the immunoaggregate formation obtained by attaching the antibody to latex particles, which is termed a LIT method. Most of the existing TIA/LIT kits are suffering from interferences due to the use of mammalian antibodies. However, for all duck IgY(ΔFc) antibody-based immunochemistry assays produced by Good Biotech, a new type of antibody, duck IgY(ΔFc), has been employed in this test system. Without the Fc domain, IgY(ΔFc) will not cross-react with the following factors which are common interferences for immunoassays:

*Complement *HAMA *Human IgG *RF/ASO *Fc receptors etc 

Therefore, duck IgY(ΔFc) antibody is absolutely an ideal choice for developing immunodiagnostics. The sensitivity, precision, and accuracy can be highly improved by using duck IgY(ΔFc) antibody as the material of immunodiagnostic reagents.      

The assay kits made from avian IgY(ΔFc) antibodies are superior to those used of mammalian antibodies because:
 
There is no immunological cross-reactivity between avian and mammalian antibodies
    (greater phylogenetic spread between both species)
They recognize more specific epitopes
They do not bind mammalian biological products, interfering with activated mammalian antibodies
 

The innovative Duck IgY(ΔFc) Antibody-based TIA/LIT kits developed & produced  by Good Biotech Corp. exhibit distinguished characteristics and features include:

Ready to use reagents, liquid format
All kits including calibrators and controls
Highly sensitivity
Excellent precision & accuracy
Wide linearity
No hook effect
Excellent reproductivity
No false-negative results
No reconstitution errors
No sample pre-treatment is necessary
Excellent on-board stability
Accurate results in low concentration sample
Shelf life stability 3 years at 4 after production
 

TIA & Latex-enhanced TIA(LIT) For automated chemistry analyzers

Good Biotech Corp. has received US FDA 510(k) clearance, CE Marking for its diagnostic products, and has obtained Taiwan- IVD GMP certification for the production of assay kit. Good Biotech has been accredited according to ISO 9001/ ISO 13485 standards, to ensure the consistency and quality of our products from lot to lot.

                                   FDA 510(K) Cleared & ISO 9001/ ISO 13485/ IVD GMP Certified

REF
CONTENTS (for details click  )
FDA 510(k) No.

SAMPLE TYPES/ASSAY RANGE

KT-0301-W

Whole Blood CRP LIT POCT

for HealthCare Professional Use

 
 
Whole Blood (Wide Range CRP): 1.3-230 mg/L
Serum/plasma (Wide Range CRP): 0.6-200 mg/L
 1010
K020603  
Serum/plasma: 0.05~20 mg/L

 Reactive buffer solution

 

 Latex solution

 

 1510

 CRPex-HS CRP Calibrator Set

     K021882

 
 2010

CRPex-BR CRP LIT Assay

     K021757
Serum/plasma: 1~300 mg/L

 Reactive buffer solution

 

 Latex solution

 
 2510

 CRPex-BR CRP Calibrator Set

     K021757

 
 3011

 CRPex CRP Control-L

     K022725

 
 3012

 CRPex CRP Control-M

     K022725

 3013

 CRPex CRP Control-H

     K022725

 4010

Duet hs-CRP LIT Assay 

     K050713
Serum/plasma: 0.1~200 mg/L

 Reactive buffer solution

 

 Latex solution

 

 4511

 Duet hs-CRP Calibrator Set

 

 
 KT-0301-D

Triplex CRP LIT Assay     

     K020603
     K021757

High Sensitivity C-Reactive Protein (hs-CRP)

Wide Range C-Reactive Protein (wr-CRP)

Analyzer

Sample Type

Assay Range: CRP(mg/L)

VITROS

Serum/Plasma

hs-CRP: 0.013-20 mg/L

wr-CRP: 0.68-250 mg/L

Whole Blood*

 

Hitachi

Serum/Plasma

hs-CRP: 0.04-20 mg/L

wr-CRP: 0.34-300 mg/L

Whole Blood

wr-CRP: 1.4-300 mg/L

   VITROS 5,1FS

  Reactive buffer solution

  Latex solution

Serum
Plasma
Whole Blood*
    HITACHI

  Reactive buffer solution

  Latex solution

Serum
Plasma
Whole Blood

 

 5010

Microalbumin TIA            

K050576  
Urine: 0~200 mg/L

 Reactive buffer solution

 

 Antibody solution

 

 5511
 Microalbumin Calibrator Set

     K050576

 
 6011

 Microalbumin Control-L

     K050576

 
 6012
 Microalbumin Control-H

     K050576

 
 7010

Ferritin LIT Assay           

     K052617
Serum/plasma: 0~1000 ng/ml

 Reactive buffer solution

 

 Latex solution

 

 7510

 Ferritin Calibrator Set

      K052617

 
 8011

 Ferritin Control-L

      K052617

 
 8012

 Ferritin Control-H

      K052617

 
 KT-0105-A

Transferrin TIA             

      K063766
Serum/plasma: 0~700 mg/dl

 Reactive buffer solution

 

 Antibody solution

 

 CA-0105-A

 Transferrin Calibrator Set

      K063766

 
 CL-0105-A

 Transferrin Control-L

      K063766

 
 CL-0105-B

 Transferrin Control-M

      K063766

 
 CL-0105-C

 Transferrin Control-H

      K063766

 
 KT-0202-A

B2M LIT Assay               

(Beta-2-Microgloblin)

 
Serum: 0.1~20 mg/L
 
Urine: 0.01~8 mg/L

 Reactive buffer solution

 

 Latex solution

 

 CA-0202-A
 B2M Calibrator Set

 

 
 CL-0202-A
 B2M Control-L

 

 
 CL-0202-B
 B2M Control-M

 

 
 CL-0202-C
 B2M Control-H

 

 

Contact  partnership@good-biotech.com for more information and a chance to work together in a mutually beneficial association.


 
Please click here to learn more about the Advantages of Duck IgY(ΔFc).
 
References:
 
"Evaluation and Validation of a Duck IgY Antibody-based Immunoassay for Measuring High Sensitivity C-Reactive Protein: Avian Antibody Application in Clinical Diagnostics"
(Clinical Chemistry)

"Standardization of Immunoassays for Measurement of High-Sensitivity C-reactive Protein. Phase I: Evaluation of Secondary Reference Materials"

(Clinical Chemistry)

Good Biotech was invited by the author (Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, US) to participate in this hsCRP project and is also one of the Latex-enhanced Immunoturbidimetry Assay manufacturers invited.

 

Below are some of the Published Papers using Good Biotech's High-sensitivity C-reactive protein (hs-CRP) Assay Kit:

 

“Circulating CD40 ligand is elevated only in patients with more advanced symptomatic peripheral arterial diseases”

   Thrombosis Research

"Coronary artery disease progression is associated with C-reactive protein and conventional risk factors but not soluble CD40 ligand"

   The Canadian Journal of Cardiology (CJC)

"The short-/intermediate-term changes in novel vascular inflammatory markers after angioplasty plus stenting in patients with symptomatic advanced systemic arterial diseases"

   Atherosclerosis

“Simvastatin reduces plasma concentration of high-sensitivity C-reactive protein in type 2 diabetic patients with hyperlipidemia”

   Journal of Diabetes and its Complications

"C-reactive protein and risk factors for peripheral vascular disease in subjects with Type 2 diabetes mellitus"

   Diabetic Medicine

"C-Graves' disease presented as painful goiter"

  Hormone Research in Paediatrics