Calypte's Alameda Facility Passes ISO 9001 Follow-up Inspection.

Business Editors/Health/Medical Writers

ALAMEDA, Calif.--(BUSINESS WIRE)--Nov. 13, 2002

Company Displays Continued Commitment to International Quality

Standards in First Regulatory Inspection Since Restart

Calypte Biomedical Corporation (OTCBB:CALY), the developer and marketer of the only two FDA-approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA-approved serum HIV-1 antibody Western Blot supplemental test, today announced its Alameda, California manufacturing facility has passed a follow-up inspection to retain its ISO 9001, ISO 13485 and EN 46001 certification status. The plant underwent a rigorous, two-day examination focused on the company's quality systems.

Nancy Katz, Calypte's chief executive officer, explained, "While ISO quality inspections occur on a regular basis, for Calypte this was our first inspection since the restart of operations, and we are delighted with the outcome. We have a company-wide commitment to quality, and maintaining our ISO certification is an important factor for our continued expansion into international markets."

Katz further stated that receiving minor observations is commonplace in such inspections. "It is heartening to receive fewer minor observations in 2002 compared with 2001, and I note that two of the three we received this year have already been closed. I extend my personal congratulations on their fine work to Calypte's Barbara McAleer, Vice President Operations/Quality, Julie Hoffman, Director of Research and Development, Roy Bearry, Sr. QA Engineer and Don Kafader, Director of Regulatory Affairs."

ISO (International Organization for Standardization) has developed a family of standards that represents an international consensus on good quality management system practices with the aim of ensuring that an organization can consistently deliver the products or services that meet its customers' quality requirements. These voluntary standards give organizations like Calypte guidelines on effective quality management systems, and measurement tools designed to give Calypte and its customers assurance that it is operating effectively. The quality audits are performed by independent third parties. Calypte's ISO auditor is G-MED.

Calypte's Alameda plant is in compliance with the appropriate ISO quality standards. The Alameda facility has also been approved by the U.S. Food and Drug Administration (FDA) for the manufacture of the company's HIV-1 Urine EIA screening test. Calypte's Rockville facility holds a biological license approval from the FDA and manufactures the company's HIV-1 Western Blot tests and houses a Biosafety Level 3 laboratory for the production of HIV-1 viral materials.

About Calypte Biomedical

Calypte Biomedical Corporation, headquartered in Alameda, California, is a public healthcare company dedicated to the development and commercialization of urine-based diagnostic products and services for Human Immunodeficiency Virus Type 1 (HIV-1), sexually transmitted diseases and other infectious diseases. Calypte's tests include the screening EIA and supplemental Western Blot tests, the only two FDA-approved HIV-1 antibody tests that can be used on urine samples, as well as an FDA-approved serum HIV-1 antibody Western Blot test. The company believes that accurate, non-invasive urine-based testing methods for HIV and other infectious diseases may make important contributions to public health by helping to foster an environment in which testing may be done safely, economically, and painlessly. Calypte markets its products in countries worldwide through international distributors and strategic partners. Refer to current product package inserts for complete information on product performance characteristics.

Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, our ability to obtain additional financing and access funds from our existing financing arrangements that will allow us to continue our current and future operations and whether demand for our product and testing service in domestic and international markets will continue and expand. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K/A (No.1) for the year ended December 31, 2001 and its subsequent filings with the SEC.