Good Biotech Corp. 最新消息

Triplex CRP LIT Assay-CE Marked on VITROS 5,1 FS

www.good-biotech.com — 1970-01-01T00:00:00+01:00

Clink here for more information about Triplex CRP LIT Assay (REF: KT-0301-D).

Whole Blood CRP LIT Assay for POCT

www.good-biotech.com — 1970-01-01T00:00:00+01:00

The next generation of Whole Blood CRP LIT Assay was developed for quantitative determination CRP for point of care testing (POCT-CRP).

April 28, 2010

Good Biotech Corp. is dedicated to the development of a brand new generation of Whole Blood CRP LIT Assay (REF: KT-0301-W) which enables precise and accurate quantitative determination of CRP (C-reactive protein) in whole blood, serum and plasma samples. In the past, quantitative measurement CRP in POCT by use small size / bench top chemistry analyzers is un-usual and rare due to suffering from reagents were not adaptable to the use of whole blood samples. Thanks to the unique advantages of duck IgY antibodies, we break through the bottleneck and developed this immediate Whole Blood CRP LIT Assay. By using single one assay kit (REF: KT-0301-W) and one calibrator (REF: 2510) , normal range CRP and low range CRP can be determined from whole bloood ,serum and plasma specimens.

Learn more about C-reactive protein

Immediate Testing for CRP Concentration; Fastest in the industry

The Whole Blood CRP LIT Assay is simple, rapid, convenient and adaptable to general clinic chemistry analyzers, in particular for the applications on POCT use compact analyzers. Moreover, the use of whole blood as samples for CRP measurement is time-saving and eliminates the step of serum-sample preparation. Through the cutting edge technology, measuring CRP concentration is only two to three minutes, enabling in-hospital immediate testing for inflammation diagnosis. Near-patient monitoring of CRP in real time is important and beneficial for improve patient care. Thus the assay is most suitable for point of care testing.

Major Features

Good Biotech Corp. Whole blood CRP LIT Assay (REF: KT-0301-W) is intended to be used for the quantitative determination of C-reactive protein in whole blood, serum and plasma by latex particle enhanced immunoturbidimetry (LIT). The measurement of C-reactive protein aids in evaluation and detection of the amount of infection, tissue injury, inflammatory disorders and associated diseases.
The one and only one IgY-based Human CRP Immunoassay in the world. A novel antibody-duck IgY(ΔFc)^•, has been employed in the Whole Blood CRP LIT assay. Duck anti-CRP IgY(ΔFc) is coupled to latex microparticles, which amplify the antigen-antibody reaction and thus greatly increase the detection sensitivity. Without the Fc domain, duck IgY(ΔFc) will not cross-react with the following factors which are common interferences for immunoassay: Complement, HAMA , Human IgG ,RF/ASO and Fc receptors etc. The sensitivity, precision, and accuracy of the assay can be highly improved by using duck IgY(ΔFc) as the material of immunodiagnostic reagents.
The test is completed within 2-3 minutes by quantitative measurement of the degree of agglutination using a bench-top analyzer in small and medium-sized laboratories or doctors' offices as well as an automated chemistry analyzer (e.g. Hitachi series) in central laboratories. Besides, the use of whole blood for CRP measurement eliminates the need for sample centrifugation or transportation and thus is most suitable for rapid point-of-care testing.

The technology platform of duck IgY(ΔFc) is solely owned by Good Biotech Corp. ; the manufacturing and the applications of duck IgY(ΔFc) antibody is patent-protected worldwide including all the major and dominant markets.

Major Specifications*

Reagent:	Liquid stable, Ready-to-use reagent.
	Both single-reagent and two-reagent formats are avaliable
Analyzer:	General clinical chemistry analyzer (auto & bench-top)
	Hematology analyzer
Measurement:	LIT (latex microparticle enhanced immonoturbidimetry)
Sample type:	Whole blood (capillary or venous whole blood), serum and plasma
Sample volume:	1μl
Wave length:	660nm, single wave length
Assay time:	120-180 seconds
Assay range:	Reliable assay range of 2-230 mg/L (whole blood)
	Reliable assay range of 1-200 mg/L (serum/plasma)
Sensitivity:	2.0 mg/L (whole blood)
	<1.0 mg/L (serum/plasma)
Detection limit:	1.3 mg/L (whole blood)
	0.6 mg/L (serum/plasma)
Antigen excess:	In whole blood and serum/plasma, up to 1000 mg/L, no hook effect.
Calibrator:	Single set calibrator
Correlation:	Good correlation with other commercial latex kits.

*Abovementioned results were obtained by Hitachi 917 (7170) analyzers.

Clink here for more information about Whole Blood CRP LIT Assay ( REF KT-0301-W).

The Patents of IgY(ΔFc) Ab has been granted in EU

www.good-biotech.com — 1970-01-01T00:00:00+01:00

The one and only one patent owner for production & applications of IgY(ΔFc) antibodies in the world. This commercialized technology is solely owned by Good Biotech Corp.and is also patented-protected worldwide including all the major and dominant markets. The patents have been granted by many countries so far such as United States, Japan, Russia, Australia, China, Taiwan, New Zealand, Singapore, Malaysia, Hong Kong , Israel, etc...and now has also been granted in European Union.

Human Albumin/IgG/Transferrin Depletion Column

www.good-biotech.com — 1970-01-01T00:00:00+01:00

REF HD-0301-10GFC

Good Biotech Corp. Human Albumin/IgG/Transferrin 3 in 1 Depletion Column is designed to specifically remove albumin, IgG and transferrin from human serum/plasma for various downstream applications, e.g. 1DE, 2DE, and LC/MS. The affinity medium in the spin column is the resin coupled with duck anti-human albumin, anti-IgG, and anti-transferrin affinity purified IgYΔFc polyclonal antibodies. Each Good Biotech Corp. Human 3 in 1 Depletion Column contains a gravity-flow column packed with 4ml affinity resin resin. The depletion spin column can remove greater than 98% of the albumin, IgG and transferrin from a 200 µl serum sample and yield about 3.0-3.4 mg/sample of total protein after single depletion process.

Features and Benefits

ü Efficient removal of albumin, IgG and transferrin by immunoaffinity capture from serum samples

ü High specific with minimal loss of other serum biomarkers

ü Fast and simple gravity-based procedure, applicable for multiple processing

ü Sufficient amount of enriched proteins from 200ml serum/plasma for one process

ü Not bind mammalian complement factor, rheumatoid factor, IgM, Fc receptor

ü Application to 1D or 2D electrophoresis, LC/MS, etc.

ü Re-usable for more than 200 cycles,cost effective for each single run

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IgY(ΔFc) Ab derived Snake Antivenom

www.good-biotech.com — 1970-01-01T00:00:00+01:00

Good Biotech Corp., an unprecedented duck IgY(ΔFc) antibody manufacturer based in Taiwan, has successfully built up the technology platform by using ducks as bio-reactors to produce a novel IgY(ΔFc) polyclonal antibody from hyperimmune duck egg yolk. Based upon the cutting edge technology and the unique characteristics of duck IgY(ΔFc) antibody, Good Biotech Corp. gained positive results on the development of IgY(ΔFc) derived snake antivenins, digoxin immune Fab and neutralizing antibodies against pathogens of bacteria, virus etc. Without having the disadvantage & limitation of traditional horse, sheep based antibodies and in the meantime, having the advantages of highly specific, high efficacy, high productivity and safety, IgY(ΔFc) antibody can be the best candidate for the new generation of Biotherapeutics.

The development of IgY(ΔFc) antibody based neuro toxin antivenoms and the study on their neutralization efficacies.

Clinical Toxicology (2008 July ; Volume 46 Issue 6, 539-544 )

Abstract

Introduction. Immunotherapy for treatment of snake bites has been based on mammalian IgG. Recently, polyvalent ovine Fab has become available. However, papain, used in the Fab fragmentation process, is a human allergen. Avian eggs are a source of antibodies and a truncated version of IgY, IgY(ΔFc), is found in ducks. In this study, we induced duck antibodies by using detoxified cobra and krait venoms and then purified IgY(ΔFc) antibodies from the hyperimmune duck egg yolk. Methods. Ducks were used for immunization and their eggs were collected for antibody production. ICR strain female mice were used in the in vivo neutralization test. Monovalent antivenoms to Formosan cobra venom and Formosan multi-banded krait venom were raised and purified from hyper-immune duck egg yolk individually. The LD₅₀ of venoms were determined by subcutaneous injection of different venom doses into the mice. The survival/death ratios were recorded after 24 hours. Results. The antibody purified from egg yolk showed high titer response to its immunogen (cobra or krait venom) by an ELISA. Overall, the antibodies from duck eggs efficiently protected mice from envenomations. Discussion. The antivenoms purified from the egg yolk of ducks immunized with cobra venom and krait venom neutralized the lethal effects of these venoms with good efficacy in a mouse model. The antivenoms were effective in neutralizing lethality in mice injected at 4LD₅₀ of venoms. Conclusions. These results indicate that antibodies derived from ducks can serve as a new source for the generation of antivenoms.

New CRP-serum/plasma/whole blood

www.good-biotech.com — 1970-01-01T00:00:00+01:00

The new generation CRP immunoassay kit-Triplex CRP LIT Assay (REF: KT-0301-D) from Good Biotech Corp.enables precise and accurate determination of C-reactive protein (CRP) in capillary or venous whole blood, plasma or serum. It is designed for use in two applications (Universal mode and High Sensitivity mode) by using different parameter settings. The Universal mode is used for CRP determination in various kinds of specimens, including plasma, serum and whole blood; the High Sensitivity mode is recommended for serum/plasma samples with CRP concentrations below 20 mg/L and where high precision and extremely good sensitivity is required.

The assay is simple, rapid, and can be cost-effectively performed on common automated chemistry analyzers or the bench-top analyzers. The use of whole blood for CRP measurement eliminates the need for sample centrifugation or transportation and thus is suitable for rapid point-of-care testing. Near-patient monitoring of CRP in real time may reduce costs and is beneficial for improved patient care.

FEATURES

Easy and reliable performance of the test

Use of whole blood, as well as serum and plasma

Test result available in minutes

Adaptable to general clinical chemistry analyzers

Quantitative results

Reliable assay range of up to 300 mg/L (Universal mode

with using serum/plasma specimens) or 20 mg/L (High

Sensitivity mode)

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