Clinical validation study of ELISA kit for detecting antibodies to SARS coronavirus receives positive results

Montreal, QC and Hong Kong September 15, 2003 Preliminary results were announced today by Adaltis and CP Adaltis of a validation study of a new ELISA kit, developed for detecting antibodies to the SARS-associated coronavirus (SARS-CoV) in the serum of patients suffering or recovering from Severe Acute Respiratory Syndrome (SARS).

The study, carried out at the department of microbiology, faculty of medicine of the Chinese University of Hong Kong, was conducted by Professor Paul Chan, and aimed at the evaluation of the Adaltis kit in serum specimens from individuals confirmed as infected with the virus and suffering or recovering from SARS, as defined by the USA CDC case definition.

The study was conducted with serum specimens from 47 subjects, which included:

– 24 SARS convalescent patients, 100% positive by IFA (indirect fluorescence assay); and
– 23 patients affected by other respiratory diseases and the test correctly detected antibodies against SARS-CoV in all but one of the 24 confirmed SARS patients.

“These are very important results in the long road to a better understanding of SARS associated coronavirus infection,” said Professor Chan. “Given the transitory presence of viral nucleic acid in the body fluids of infected patients and the short window of opportunity for the detection of the virus by PCR, the availability of a reliable antibody detection kit, offering the most solid evidence of contact between patients and the virus, is a very potent complementary diagnostic tool.”

Detect-SARS is based on a mixture of synthetic peptides discovered by Adaltis’ scientists derived from SARS-CoV sequences sharing no similarity of sequences with common coronaviruses. These peptides mimic epitopes of SARS-CoV, without showing any significant homology with other coronaviruses epitopes, ensuring a very specific detection of anti-SARS CoV antibodies.

“Based on the established enzyme linked immuno assay (ELISA) technology, our microplate kit can reliably detect anti SARS associated CoV antibodies in about two hours, using standard laboratory instrumentation at an affordable cost,” says Dr Michel Houde, senior research director of Adaltis.

“Our results were made possible also by the important findings of several research groups and by the positive attitude towards the sharing of knowledge by leading institutions. We are very happy with the productive collaboration developed between the academic world and industry as well as between Hong Kong and Canada. We are now focusing our efforts to rapidly obtain the necessary regulatory approvals of our kit,” adds Dr Houde.

Adaltis says it plans to manufacture Detect-SARS in its Italian, Canadian and Chinese plants in order to ensure adequate production capacity. CP-Adaltis, the Hong Kong based joint venture between CITIC Pacific and Adaltis, will be responsible for the commercialisation of the kit in China via its wholly owned subsidiary, Shanghai CP-Adaltis Diagnostic and DCH Healthcare Products in Hong Kong. Distribution of the kits for the rest of the world will be done through Adaltis.