Immunochemistry - Turbidimetric Immunoassay Reagents

IgY(ΔFc) Antibody-based turbidimetric immunodiagnostic assay (TIA) reagents and latex microparticle-enhanced immunoturbidimetry (LIT) assays

The diagnostic reagents Good Biotech Corp. manufactures and offers in the field of in vitro diagnostics include turbidimetric immunodiagnostic assay (TIA) reagents and latex microparticle-enhanced immunoturbidimetry (LIT) assays. 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 as LIT methods. Most of the existing TIA/LIT kits suffer 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 immunoassay:

*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 can be superior to those use 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  )
PACKAGE

SPECIMEN/ ASSAY RANGE

KT-0301-W

Whole Blood CRP LIT Assay

Whole Blood CRP for POCT

 
Whole blood: 1.3-230 mg/L
Serum/plasma: 0.6-200 mg/L
 1010
 
Serum/plasma: 0.05~20 mg/L

 Reactive buffer solution

 1 x 20 mL

 Latex solution

 1 x 20 mL

 1510

 CRPex-HS CRP Calibrator Set

 6 conc.× 1 mL

 
 2010

CRPex-BR CRP LIT Assay

 
Serum/plasma: 1~300 mg/L

 Reactive buffer solution

 1 x 50 mL

 Latex solution

 1 x 50 mL

 2510

 CRPex-BR CRP Calibrator Set

 6 conc.× 1 mL

 
 3011

 CRPex CRP Control-L

 1 x 1  mL

 
 3012

 CRPex CRP Control-M

 1 x 1  mL

 3013

 CRPex CRP Control-H

 1 x 1  mL

 4010

Duet hs-CRP LIT Assay 

 
Serum/plasma: 0.1~200 mg/L

 Reactive buffer solution

 1 x 20 mL

 Latex solution

 1 x 20 mL

 4511

 Duet hs-CRP Calibrator Set

 6 conc.× 1 mL

 
 KT-0301-D

Triplex CRP LIT Assay     

 

  Whole blood: 

       1.4~300 mg/L (universal)

  Serum/plasma: 

       0.34~300 mg/L (universal)

               0.013~20 mg/L (high sensitivity)

  Reactive buffer solution

  Latex solution

 

1 x 14.8 mL

1 x 9.9 mL

HITACHI

  Reactive buffer solution

  Latex solution

 

1 x 60 mL

1 x 15 mL

 5010

Microalbumin TIA            

 
Urine: 0~200 mg/L

 Reactive buffer solution

 1 x 58 mL

 Antibody solution

 1 x 7 mL

 5511
 Microalbumin Calibrator Set

 5 conc.× 1 mL

 
 6011

 Microalbumin Control-L

 1 x 1 mL

 
 6012
 Microalbumin Control-H

 1 x 1 mL

 
 7010

Ferritin LIT Assay           

 
Serum/plasma: 0~1000 ng/ml

 Reactive buffer solution

 1 x 34 mL

 Latex solution

 1 x 20 mL

 7510

 Ferritin Calibrator Set

 5 conc.× 1 mL

 
 8011

 Ferritin Control-L

 1 x 1 mL

 
 8012

 Ferritin Control-H

 1 x 1 mL

 
 KT-0105-A

Transferrin TIA              

 
Serum/plasma: 0~700 mg/dl

 Reactive buffer solution

 2 x 55 mL

 Antibody solution

 2 x 7 mL

 CA-0105-A

 Transferrin Calibrator Set

 6 conc.× 1 mL

 
 CL-0105-A

 Transferrin Control-L

 1 x 1 mL

 
 CL-0105-B

 Transferrin Control-M

 1 x 1 mL

 
 CL-0105-C

 Transferrin Control-H

 1 x 1 mL

 
 KT-0202-A

B2M LIT Assay               

(Beta-2-Microgloblin)

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

 Reactive buffer solution

 1 x 30 mL

 Latex solution

 1 x 20 mL

 CA-0202-A
 B2M Calibrator Set

 6 conc.× 1 mL

 
 CL-0202-A
 B2M Control-L

 1 x 1 mL

 
 CL-0202-B
 B2M Control-M

 1 x 1 mL

 
 CL-0202-C
 B2M Control-H

 1 x 1 mL

 
 
  • Products are available in KIT FORMAT, BULK FORMAT, GOOD BIOTECH-& PRIVATE LABEL
  • Distributor,  Bulk and OEM partnerships are welcome  
 

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"

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

MM Kimberly et al., Clinical Chemistry 2003 Apr;49(4):611-6.

-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 four 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 for their studies :

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

WJ Lee et al., 2006;118(5):619-26. Epub 2005 Dec 13.

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

KW Liang et al., Can J Cardiol. 2006 Jun;22(8):691-6.

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

WJ Lee et al., 2004 Sep;176(1):125-32.

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

IT Lee et al., J Diabetes Complications. 2002 Nov-Dec;16(6):382-5.

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

HI Yu et al., Diabet Med. 2004 Apr;21(4):336-41.