Muse HIV/AIDS Diagnostic Kit

Partnership objective 

Developing a novel, portable instrument to monitor the progression of the HIV/AIDS virus in adults and children.

A more sensitive instrument that addresses the needs of adults and children. A more sensitive instrument that addresses the needs of adults and children. Copyright Merck

What are the needs and challenges?

Very few vendors develop instruments and assays that can monitor virus in children. Merck Millipore is developing the Muse Auto CD4/CD4% system to address the needs of adults and children. This system offers a 10µL blood sample requirement, the lowest in the industry. In addition, Merck offers a combined CD4 enumeration and CD4% measurement on all human samples.  CD4% measurement is required to monitor the advancement of the virus in pediatric patients.

The second challenge is in sensitivity.  As the virus progresses, the CD4 count and the CD4% measurements decrease.  Patients are monitored for potential recovery.  The ability to count CD4 positive samples at low levels can reveal if the treatments are successful.

Description of partnership activities and how they address needs and challenges

Merck Millipore partnered with the University of California at San Francisco as a pre-clinical site to determine if the product had the potential to monitor the progression of the virus as well as the predecessor product, the Guava Auto CD4/CD4% system.  This was a very successful trial.

The true test for the Muse Auto CD4/CD4% system occurred at the University of Yaounde in Cameroon.  Both adult and pediatric patients were successfully processed on the Muse Auto CD4/CD4% system. A poster from that trial that was presented at the ICAAC meeting in Washington, DC in September 2014. The Muse Auto CD4/CD45 system worked well with adults and children samples. In addition, the Muse Auto CD4/CD4% system performed well with cytopenic specimen.

Merck Millipore will offer a more sensitive instrument that addresses the needs of adults and children at a modest price. The cost-per-test will be at very low price, opening access. Merck Millipore has added accessory battery UPS options that will power the instrument in the field for up to four hours.  This allows for ambulatory care as well as laboratory use. The product is very easy to use and intended for use in developing countries. The Muse Auto CD4/CD4% system is one of only a few vendors addressing the needs of paediatric viral patients.  

Lessons learned

The electricity and weather conditions in Cameroon can challenge laboratory instrumentation.  Most laboratories in developing countries are not air conditioned.  The temperatures can be quite warm and the humidity can be quite high under conditions close to the equator in Cameroon. To make the Muse Auto Cd4/CD4% more durable and operable under these conditions, several enhancements have been introduced.  These improvements include a new laser, a new mother board, new electric grounding capability, new battery powered uninterrupted power supply units, and new software developments adding an “extreme cleaning” function to maintain the Muse Auo CD4/CD4% system and improved auto-gating to increase further the sensitivity and specificity of results. Merck Millipore is now making these improvements. Once these enhancements are accomplished, the clinical trials in Cameroon will continue.

Summary of impact and forward looking information

The Muse Auto CD4/CD4% system product release will be delayed until the end of Q1 2015.  Merck Millipore will then begin the process to gain pre-qualification from the World Health Organization.  In addition, Merck Millipore intends to work with UNITAIDS to fast track clinical trials to gain IVD acceptance throughout sub Saharan Africa and Southeast Asia.

Partnership information

Company(ies) Merck

Partner(s) University of California, San Francisco, University of Yaoundé

Type of Partner(s) Academia / Hospitals

Therapeutic Focus Infectious Diseases

Disease(s) HIV/AIDS

Program Type(s) Health System Infrastructure - Outreach & Medical Services, Research & Development - Operations Research

Targeted Population(s) Children, Men, People with low income, Women

Region(s) North America, Sub-Saharan Africa

Number of Countries 2

Country(ies) Cameroon, United States of America

Start Date 2014

Anticipated completion date Ongoing