1 Kit

96-well ELISA

A rapid urine test for early detection of kidney injury
     Kidney injury molecule-1 (Kim-1) has been qualified by the Food and Drug Administration and European Medicines Agency as a highly sensitive and specific urinary biomarker to monitor drug-induced kidney injury in preclinical studies and on a case-by-case basis in clinical trials. Here we report the development and evaluation of a rapid direct immunochromatographic lateral flow 15-min assay for detection of urinary Kim-1 (rat) or KIM-1 (human).
      The urinary Kim-1 band intensity using the rat Kim-1 dipstick significantly correlated with levels of Kim-1 as measured by a microbead-based assay, histopathological damage, and immunohistochemical assessment of renal Kim-1 in a dose- and time-dependent manner. Kim-1 was detected following kidney injury induced in rats by cadmium, gentamicin, or bilateral renal ischemia/reperfusion. In humans, the urinary KIM-1 band intensity was significantly greater in urine from patients with acute kidney injury than in urine from healthy volunteers.
     The KIM-1 dipstick also enabled temporal evaluation of kidney injury and recovery in two patients who developed postoperative acute kidney injury following cytoreductive surgery for malignant mesothelioma with intraoperative local cisplatin administration. We hope that future, more extensive studies will confirm the utility of these results, which show that the Kim-1/KIM-1 dipsticks can provide a sensitive and accurate detection of Kim-1/KIM-1, thereby providing a rapid diagnostic assay for kidney damage and facilitating the rapid and early detection of kidney injury in preclinical and clinical studies. ...
     RenaStick was developed at Bioassay Works using epitopically distinct antibodies raised in our laboratory ... An extensive characterized and evaluation of RenaStick was then performed in our laboratory. ...

Excerpted text above is ©2009 International Society of Nephrology, February
http://www.kidney-international.org
Kidney International advance online publication, 22 April 2009; doi:10.1038/ki.2009.96
KEYWORDS: biomarkers; cadmium; dipstick; ischemia/reperfusion injury; kidney toxicity; Kim-1
Vishal S. Vaidya, Glen M. Ford, Sushrut S. Waikar, Yizhuo Wang, Matthew B. Clement, Victoria Ramirez, Warren E. Glaab, Sean P. Troth, Frank D. Sistare, Walter C. Prozialeck, Joshua R. Edwards, Norma A. Bobadilla, Stephen C. Mefferd and Joseph V. Bonventre
Correspondence: Vishal S. Vaidya, Renal Division, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Harvard Institutes of Medicine, Room no. 568, 4 Blackfan Circle, Boston, Massachusetts 02115, USA. E-mail: vvaidya@partners.org

Complete article is available for subscribers at http://www.nature.com/ki/journal/v76/n1/full/ki200996a.html

Sales Contact for RenaStick: Stephen Mefferd, V.P. Business Development
Email: smefferd@bioassayworks.com

Rapid-Format Assay

• The photo on the right shows three assays detecting E. coli 0157. The detection is from a low of 10³ to 10⁵. The important fact to note is achievement of microwell ELISA sensitivity on a rapid-format assay.
• The founders of BioAssay Works have nearly 50 years experience in the purification and development of bio-receptors in assay systems. Coupled with proprietary improvements that enable the synthesis of gold sols at concentrations 10-20 times conventional levels, BioAssay Works offers a powerful package of products and services that promise reliability and reduced costs for the development of rapid, lateral-flow assays.

Gold Nanoparticles

• BioAssay Works offers extensive experience in the development of rapid, point-of-care, lateral-flow-format diagnostic assays.
• Our proprietary concentrated gold sols may be used in conjunction with our patented C-FLAT® (Counter Flow Amplified Test) assay plaform for significant savings in both development time and money.
• Key services include contract assay development and manufacturing, antibody development, lateral-flow component optimization, and reagent supply.