Value for Money (VFM) Project

George Janossy
 

This VFM project was initiated to combine the aim of decreasing CD4 costs with increasing the quality and precision of the laboratory service. The initiative started in August 2001 as a multi-centric study involving several African laboratories. The participants are listed below (1). The goal of this project was to evaluate, in field conditions, the performance of the recently standardised “CD45 assisted PanLeucogating” protocol. As a result of this study three abstracts have been written. One was presented by Dr. A. Bikoue at the C.I.S.M.A. in Bourkina Faso in December 2001. Two studies have been submitted to the coming International AIDS Conference in Barcelona, 2002 and are briefly summarised below.

 
The first set of results by Wilja Mandy from Robert Downing’s group (2) shows a comparison of PanLeucogating on a FACScan with (i) a double platform approach using lymphocyte gating on a FACScan, and (ii) a single platform FACSCount. The inclusion of the FACSCount is a novel aspect of this study as this instrument was not analysed by Dr. Glencross. In Mandy’s study Transfix was also evaluated for stabilising blood. On fresh cells, FACSCount results correlated better with PanLeucogating (R2=0.94) than with the traditional double platform assay (R2=0.64). On cells stabilized with Transfix, the correlation between results at day 3 and day 0 was excellent for FACSCount (R2=0.97) and PanLeucogating (R2=0.96) but less impressive for the traditional double platform assay (R2=0.42). Correlation between results at day 7 and day 0 were good only for PanLeucogating (R2=0.85). Re-gating was frequently necessary with the lymphocyte gating protocol when using Transfix, but rarely with PanLeucogating. The authors conclude that PanLeucogating would make CD4+ T cell monitoring more accessible in resource-poor settings and this protocol is compatible with the use of TransFix. Also, the potential cost of a CD4+ T cell count using PanLeucogating is now under 5 US$. This new price level compares favourably with the current market cost of CD4 T cell enumeration around 20 US$.

The second set of results by S. Tugume from Dr. Mugyenyi’ Institute also reveals the close correlation between the new PanLeucogating protocol performed on a FACSCalibur with a bead-based single platform approach that used TRUCount tubes for obtaining absolute counts. A correlation of r=0.947 was found between PanLeucogating and the TRUCount methods. A further detailed analysis showed that CD4 counts at the clinically important range between 200 and 500 had a good fit (r=0.947). In the ranges of the counts <200 and those >500/mm3 the correlation between the two methods was still acceptable (r=0.813 and 0.774, respectively). The authors conclude that affordable CD4 tests could replace the expensive TRUCount tests because in their hands the CD45 assisted PanLeucogating method represents about 75% cost saving.

  We are therefore pleased to report that the aims of our collaboration have been achieved. Interestingly, as a result of the lower costs, in Dr. Mugyenyi’s Institute there has already been a considerable increase in CD4 testing. Consequently, with the Affordable CD4 technology we can report a substantial progress, a relevant development for the upcoming HIV therapeutic trials driven by the arrival of generic drugs for anti-viral therapy.

 
The Group Leaders participating in the study:

Uganda:

Dr. Robert Downing, CDC/UVRI, Entebbe,Uganda" <rqd6@CDC.gov>

Dr. Sitefano B. Tugume, Joint Clinical Research Centre,Kampala, Uganda <sbtugume@jcrc.co.ug>

 
Tanzania:

Dr. Eligius Lyamuya, Tanzania" <eligius_lyamuya@yahoo.com>

Dr. Roland Gosling, Tanzania" <RolyGos@aol.com>

Prof. Fred Mhalu, Tanzania"<fmhalu@muchs.ac.tz>

Prof. Gunnel Biberfeld, MRC Sweden" <gunnel.biberfeld@smi.ki.se>

 

France (Congo):

Dr. Arsene Bikoue, France" <bikoue@caramail.com

 

Zambia:

Ms. Gina Mulundu, Zambia" <gmulundu@zamtel.zm>

Dr. Peter Mwaba, Zambia" <p_mwaba@hotmail.com>

Dr. Diana Gibb, MRC UK" <Di.Gibb@ctu.mrc.ac.uk>

 

Zimbabwe:

Dr.Lynn Zijenah, Zimbabwe" <lzijenah@healthnet.zw>

Mrs Eve Gadzikwa, Zimbabwe" <zinqap@healthnet.zw>

Mr. Boniface Mudenge, Zimbabwe"<mudenge@telco.co.zw>
Submitted Abstracts

1.  

Wilja Mandy, George Janossy, Deborah Glencross, David Barnett, Jonathan Mermin, Robert Downing. “Less Expensive CD4+ T Cell Monitoring using Panleucogating” submitted to the Barcelona meeting.

 
2.   

Sitefano B. Tugume, Tomas W. Otim, Diana Atwiine, John Okiror, Cissy Kityo, Peter N. Mugyenyi, George Janossy  “Inexpensive CD4 lymphocyte subset estimation by dual platform (dp) CD45 assisted PanLeucogating method using afford monoclonal antibodies” submitted to the Barcelona meeting.

 

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