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Faulty Antibodies Continue to Enter US and European Markets, Warns Top Clinical Chemistry Researcher

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One year after alerting the proteomics community to a Chinese life sciences company that he said had infiltrated the US and European markets with faulty antibodies, researcher Nader Rifai told ProteoMonitor this week that the rogue firm is still at it.

Rifai, director of clinical chemistry at Children's Hospital Boston, first warned of the faulty antibodies in an editorial he co-authored in the October 2012 issue of Clinical Chemistry – of which he is editor-in-chief – along with Greg Miller, president of the American Association for Clinical Chemistry, and Ian Watson, president of the European Federation of Clinical Chemistry (PM 11/9/2012).

At the time, Rifai declined to go on the record with the identity of the antibody supplier, saying that it would be inappropriate in his role as a journal editor. This month, however, Clinical Chemistry published a study led by University of Toronto researcher Eleftherios Diamandis that identified the company in question as USCN Life Sciences, and, given this publication and the firm's continued sale of faulty reagents, Rifai said that he had decided to go public with the name.

Based in Wuhan, China, USCN produces antibodies, proteins, and immunoassay kits. According to Rifai, the company also operates under the names EIAab and EIAab Wuhan. Rifai added that he has contacted the US Federal Trade Commission about USCN, and that the commission has launched an investigation into the firm. Due to the US federal government shutdown, FTC representatives were not available to speak about the case.

As Rifai told ProteoMonitor last year, there are several things about USCN's products and practices that should tip off researchers to potential problems – most notably the lack of meaningful reference material accompanying the antibodies and the large number of antibodies, including quite obscure proteins, offered by the firm.

He contrasted USCN to the well-established ELISA firm R&D Diagnostics, which, despite being in business for several decades has assays to only several hundred targets.

"Then, you have this other company that comes out of nowhere and overnight has [antibodies to] more than 2,000 [proteins] – and not only for humans, but for 10 or 20 different species," he said. "How can you possibly do that?"

Rifai also suggested that USCN had managed to keep its products' failings largely under wraps by charging high prices for its antibodies – between $1,000 and $1,500 for reagents that generally cost in the $200 to $400 range.

This practice, he said, works on two fronts. First, by making the reagents that expensive, the company reduces the likelihood that researchers will use their limited budgets to order the extra quantity required to do solid validation of their purchase.

Secondly, he suggested, "psychologically, people say, 'Well, if I am paying so much money for something, it has to work.'"

As they noted in their Clinical Chemistry paper, Diamandis and his colleagues discovered that the USCN-sourced antibody was faulty in the course of research into protein biomarkers for pancreatic cancer. They used the antibody, which they initially believed was to the protein CUZD1, for testing pancreatic cancer patient serum samples, finding that CUZD1 appeared to be a promising marker for the disease.

When they tried to characterize the antibody as part of their validation process, however, they found that it recognized not CUZD1 but, rather, the established cancer marker CA125. This led the researchers to further investigate the antibody using additional methods including mass spectrometry, an effort that they said took two years and cost roughly $500,000.

In addition, they wrote, the process "wasted thousands of highly valuable patient samples and raised false expectations due to the misleading results."

The Clinical Chemistry paper is not the first publication to identify USCN as a producer of faulty antibodies. Last September, even before Rifai published his editorial, researchers from Harvard Medical School and the University of Alabama published a letter to the editor in the American Journal of Nephrology in which they expressed concern about a previously published study using a USCN ELISA for measuring HJV protein.

In their letter, the researchers wrote that through efforts to replicate this study, they had determined that the "USCN HJV ELISA does not detect human or mouse HJV, but is instead recognizing some other protein(s)."

Contacted by ProteoMonitor via email, USCN General Engineer Wang Jing suggested that Rifai's accusations were the result of "misunderstandings," and added that "USCN makes every effort to guarantee the quality of our products. We have [a] strict QC process to ensure the products’ quality."

Jing did not respond by press time to the specific findings of the Diamandis study or the AJN letter.

Perhaps more alarming than USCN's alleged practices, Rifai said, is the fact that they have managed to obtain wide US and European distribution for their products, including through well regarded distributors.

He cited as an example Seattle-based distributor Kamiya Biomedical, which, he said, is a "very reputable" distributor from which his lab purchases tests for clinical use.

Recently, Rifai said, his lab purchased a kit from Kamiya that they suspected might be coming from USCN.

"Before we purchased the kit, we called them and said, 'Is there any chance that this is from China?'" he said. "And they said, 'No, no, this is coming from Japan.'"

"So, we purchased the kit and we got the kit and all the labels on the vial say Kamiya, and all the inserted sheets says Kamiya," he said. "The only thing is, when you look at the top of the vial, it has the insignia of USCN Life Sciences."

Kamiya did not reply to several requests for comment.

Distributors "hide behind the excuse that, well, this is for research-use only, so use it at your own risk," Rifai said. "And I can accept that argument to a certain extent. But when someone is knowingly cheating, that is different."

He noted that while the FTC investigation would not be able to shut down USCN – and that even if it did, the company would likely just pop up again under a different name – he hoped that the commission might make US-based distributors liable for the products they sell.

This step "might not be reasonable" either, however, Rifai acknowledged, noting that, ultimately, the best solution to the problem is for individual investigators to do appropriate due diligence on the reagents they use.

He added that while Diamandis' investigation into the faulty CUZD1 antibody cost around $500,000, researchers didn't need to take such extensive steps to protect themselves.

"Honestly, all you need to do is buy two kits and you can evaluate them and tell if the assay works or not," he said. "I wish fraudulent companies did not exist, but if scientists do what they are supposed to do, they can save themselves a lot of heartache."

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