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Multicenter Study
. 2009 Nov 27;23(18):2459-66.
doi: 10.1097/QAD.0b013e328331f702.

Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities

Sarah M Lofgren  1 , Anne B Morrissey, Caroline C Chevallier, Anangisye I Malabeja, Sally Edmonds, Ben Amos, David J Sifuna, Lorenz von Seidlein, Werner Schimana, Wendy S Stevens, John A Bartlett, John A Crump
Affiliations
Multicenter Study

Evaluation of a dried blood spot HIV-1 RNA program for early infant diagnosis and viral load monitoring at rural and remote healthcare facilities

Sarah M Lofgren et al. AIDS. .

Abstract

Objective: To assess technical and operational performance of a dried blood spot (DBS)-based HIV-1 RNA service for remote healthcare facilities in a low-income country.

Design: A method comparison and operational evaluation of DBS RNA against conventional tests for early infant diagnosis of HIV and HIV RNA quantitation under field conditions in Tanzania.

Methods: DBSs were prepared and plasma was frozen at -80 degrees C. DBSs were mailed and plasma couriered to a central laboratory for testing using the Abbott m2000 system. Infant diagnosis DBSs were also tested for HIV-1 DNA by ROCHE COBAS AmpliPrep/COBAS TaqMan System. Results of DBS RNA were compared with conventional tests; program performance was described.

Results: Among 176 infant diagnosis participants, using a threshold of at least 1000 copies/ml, sensitivity and specificity of DBS versus plasma RNA were 1.00 and 0.99, and of DBS RNA versus DBS DNA were 0.97 and 1.00. Among 137 viral load monitoring participants, when plasma and DBS RNA were compared, r value was 0.9709; r value was 0.9675 for at least 5000 copies/ml but was 0.7301 for less than 5000 copies/ml. The highest plasma RNA value at which DBS RNA was not detected was 2084 copies/ml. Median (range) turnaround time from sample collection to result receipt at sites was 23 (4-69) days. The Tanzania mail service successfully transmitted all DBS and results between sites and the central laboratory.

Conclusion: Under program conditions in Tanzania, DBS provided HIV-1 RNA results comparable to conventional methods to remote healthcare facilities. DBS RNA testing is an alternative to liquid plasma for HIV-1 RNA services in remote areas.

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Figures

Figure 1
Figure 1
Flow diagram, field study of a dried blood spot nucleic amplification method for infant HIV diagnosis and viral load determination in Tanzania, 2008-9 Part A: early infant diagnosis; Part B: viral load monitoring; QNS= Quantity not sufficient; Lost with assay errors= instrument flags, usually associated with inadequate volume detection, resulting in sample loss.
Figure 2
Figure 2
Linearity plot of plasma versus DBS log HIV-1 RNA concentration, Tanzania, 2008-9
Figure 3
Figure 3
Bland Altman difference plot comparing DBS with plasma HIV-1 RNA concentration, Tanzania 2008-9
See this image and copyright information in PMC

Comment in

References

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