Early Infant Diagnosis Specimen Rejection Rate at Mutare Provincial Hospital Laboratory, Zimbabwe
Introduction: According to the World Health Organisation (WHO), all HIV exposed infants should be tested by Dried
Blood Spots (DBS)-Polymerase Chain Reaction (PCR) before or at 6 weeks of age, in the so-called early infant diagnosis
(EID) programme. This is because there have been prior reports of high morbidity and mortality in HIV-infected infants
and children due to inadequate care and treatment in many developing countries, mostly due to unknown HIV status. EID
testing is a crucial step to facilitate early access to antiretroviral treatment (ART). In order to inform clinicians, policy
makers and the public, we carried out a study to determine specimen rejection rate and the reasons for specimen
rejection by retrospectively reviewing records of Dried Blood Spot (DBS) samples received at Mutare Provincial Hospital
Molecular Diagnostics Laboratory for HIV EID in Zimbabwe.
Aim of Study: To determine the specimen rejection rate and reasons for sample rejection at the EID Laboratory at
Mutare Provincial Hospital as a way to ensure continuous availability of good quality diagnostic systems for HIV infected
women, their infants and families.
Methods: This was a cross-sectional retrospective study conducted on data for samples submitted to Mutare Provincial
Hospital Molecular Diagnostics Laboratory. The data was collected over a 1-year period from January 2015 to December
2015 and was retrieved from the laboratory’s information database in January 2016. The records included date of
specimen collection; date specimen was received at the laboratory and reasons for specimen rejection.
Results: The specimen rejection rate was 10.7%. The reasons for rejection included improper specimen collection
(24.8%), no specimen received (12.6%), multiple specimens packed in one sample pack (17.2%), specimens and forms
not labelled correctly (8.5%), specimens tested that requested for a new specimen due to machine error hence rejected
during testing (16.6%), specimens tested but failed (8.2%) and specimens tested with an indeterminate result (12.2%).
Conclusion: The study demonstrates that DBS specimen rejection in our setting (10%) is far higher than the 1-3%
reported by the Clinton Health Access Initiatives, a global organisation spearheading research on HIV diagnostic tests in
low and middle income countries. Rejection was mainly due to human error (83.4%) hence this necessitates intensified
training and monitoring of local personnel and integrating quality policies for specimen collection and processing to
prevent specimen rejection. Other considerations could include continuous counselling of clinicians and medical
laboratory scientists in order to improve sample quality and specimen handling as a way to achieve the goals of the
national EID program.