Performance of the PointCare NOW system for CD4 counting in HIV patients based on five independent evaluations.
BACKGROUND
Point-of-care (POC) CD4 testing can improve access to treatment by enabling decentralization and reducing patient loss-to-follow-up. As new POC CD4 technologies become available, their performance should be assessed before widespread deployment. This study reports the findings of five independent evaluations of the PointCare NOW CD4 system.


METHODS
Evaluations were conducted in Southern Africa (Mozambique, South Africa) and North America (Canada, USA). 492 blood samples (55 from HIV-negative blood donors and 437 from HIV-infected patients, including 20 children aged between 12 and 59 months) were tested with both the PointCare NOW and reference flow cytometry instruments. Assessment of bias, precision and levels of clinical misclassification for absolute and percent CD4 count was conducted.


RESULTS
PointCare NOW significantly overestimated CD4 absolute counts with a mean relative bias of +35.0%. Bias was greater in samples with CD4 counts below ≤ 350 cells/µl (+51.3%) than in the CD4 >350 cells/µl stratum (15.1%). Bias in CD4% had a similar trend with an overall relative mean bias of +25.6% and a larger bias for low CD4 stratum (+40.2%) than the higher CD4 stratum (+5.8%). Relative bias for CD4% in children was -6.8%. In terms of repeatability, PointCare NOW had a coefficient of variation of 11%. Using a threshold of 350 cells/µl, only 47% of patients who qualified for antiretroviral therapy with reference CD4 testing, would have been eligible for treatment with PointCare NOW test results. This was 39% using a 200 cells/µl threshold. Agreement with infant samples was higher, with 90% qualifying at a 25% eligibility threshold.


CONCLUSIONS
The performance of the PointCare NOW instrument for absolute and percent CD4 enumeration was inadequate for HIV clinical management in adults. In children, the small sample size was not large enough to draw a conclusion. This study also highlights the importance of independent evaluation of new diagnostic technology platforms before deployment.
Public Health Agency of Canada, National Laboratory for HIV Immunology, Ottawa, Canada.
Michèle
M
Bergeron
Géraldine
G
Daneau
Tao
T
Ding
Nadia E
NE
Sitoe
Larry E
LE
Westerman
Jocelijn
J
Stokx
Ilesh V
IV
Jani
Lindi M
LM
Coetzee
Lesley
L
Scott
Anja
A
De Weggheleire
Luc
L
Boel
Wendy S
WS
Stevens
Deborah K
DK
Glencross
Trevor F
TF
Peter
D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count / Q000379:methods* / Q000592:standards; D002675:Child, Preschool; D004608:Eligibility Determination; D015658:HIV Infections / Q000188:drug therapy / Q000276:immunology*; D006801:Humans; D007223:Infant; D019095:Point-of-Care Systems / Q000592:standards; D011786:Quality Control; D012680:Sensitivity and Specificity
D019380:Anti-HIV Agents