False-positive HIV DNA PCR testing of infants: Implications in a changing epidemic

Feucht, Ute Dagmar; Forsyth, Brian W.C.; Kruger, Mariana

doi:10.7196/samj.4951

Cited by 33 publications

(26 citation statements)

References 8 publications

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“…Also, some natural polymorphisms favor the emergence of variants fully resistant to antiretrovirals [12], which not only affect drug-resistance interpretation when using different algorithms and generate discrepant results [13], but also increase ART-failure risk in some subtypes [14–16]. HIV-1 genetic variability can also lead to viral load (VL) underestimation or to no HIV-1 RNA detection [17], thus affecting early molecular diagnosis and ART-monitoring [17–20]. Since dried blood spots (DBS) are less infective, easier to collect, store, and transport than whole blood or plasma and with comparable performance for monitoring HIV infection in Public Health Programs [21], the WHO has recommended their use for improving access to virological testing, including viral load and drug resistance monitoring [22].…”

Section: Introductionmentioning

confidence: 99%

HIV-1 Variants and Drug Resistance in Pregnant Women from Bata (Equatorial Guinea): 2012-2013

et al. 2016

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ObjectivesThis is the first study describing drug resistance mutations (DRM) and HIV-1 variants among infected pregnant women in Equatorial Guinea (GQ), a country with high (6.2%) and increasing HIV prevalence.MethodsDried blood spots (DBS) were collected from November 2012 to December 2013 from 69 HIV-1 infected women participating in a prevention of mother-to-child transmission program in the Hospital Regional of Bata and Primary Health Care Centre María Rafols, Bata, GQ. The transmitted (TDR) or acquired (ADR) antiretroviral drug resistance mutations at partial pol sequence among naive or antiretroviral therapy (ART)-exposed women were defined following WHO or IAS USA 2015 lists, respectively. HIV-1 variants were identified by phylogenetic analyses.ResultsA total of 38 of 69 HIV-1 specimens were successfully amplified and sequenced. Thirty (79%) belonged to ART-experienced women: 15 exposed to nucleoside reverse transcriptase inhibitors (NRTI) monotherapy, and 15 to combined ART (cART) as first regimen including two NRTI and one non-NRTI (NNRTI) or one protease inhibitor (PI). The TDR rate was only found for PI (3.4%). The ADR rate was 37.5% for NNRTI, 8.7% for NRTI and absent for PI or NRTI+NNRTI. HIV-1 group M non-B variants caused most (97.4%) infections, mainly (78.9%) recombinants: CRF02_AG (55.2%), CRF22_A101 (10.5%), subtype C (10.5%), unique recombinants (5.3%), and A3, D, F2, G, CRF06_cpx and CRF11_cpx (2.6% each).ConclusionsThe high rate of ADR to retrotranscriptase inhibitors (mainly to NNRTIs) observed among pretreated pregnant women reinforces the importance of systematic DRM monitoring in GQ to reduce HIV-1 resistance transmission and to optimize first and second-line ART regimens when DRM are present.

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Section: Introductionmentioning

confidence: 99%

HIV-1 Variants and Drug Resistance in Pregnant Women from Bata (Equatorial Guinea): 2012-2013

et al. 2016

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“…The percentage of false-positive PCRs in our cohort with limited PMTCT is similar to the expected number for a 30% rate of MTCTof HIV, calculated to be 1.4% by a group in South Africa and 2.3% in WHO guidelines [4,30]. Despite laboratory quality assurance, potential remains for false-positive PCRs related to the inherent test characteristics as well as to errors in transcription and labeling, among others, at the many steps between specimen collection and return of results.…”

Section: Discussionmentioning

confidence: 95%

False-negative post-18-month confirmatory HIV tests in HIV DNA PCR-positive children

Garcia-Prats

Draper

Sanders

et al. 2012

Aids

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“…Understanding where errors occur within the testing process can assist with redesigning systems that render it difficult for health-care professionals to make mistakes, thereby reducing wastage of resources both within the clinic and laboratory [24]. Furthermore, due to the dramatic increase in the volume of testing performed over recent years as well as concerns that changes within the PMTCT program and testing landscape could impact negatively on diagnostic quality [25,26], assessing the trend of MDOs is imperative. Towards this end we describe HIV PCR test rejections and indeterminate results, and the associated delay in diagnosis, within South Africa’s early infant diagnosis program from 2010 to 2015.…”

Section: Introductionmentioning

confidence: 99%

Missed diagnostic opportunities within South Africa’s early infant diagnosis program, 2010–2015

2017

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BackgroundSamples submitted for HIV PCR testing that fail to yield a positive or negative result represent missed diagnostic opportunities. We describe HIV PCR test rejections and indeterminate results, and the associated delay in diagnosis, within South Africa’s early infant diagnosis (EID) program from 2010 to 2015.MethodsHIV PCR test data from January 2010 to December 2015 were extracted from the National Health Laboratory Service Corporate Data Warehouse, a central data repository of all registered test-sets within the public health sector in South Africa, by laboratory number, result, date, facility, and testing laboratory. Samples that failed to yield either a positive or negative result were categorized according to the rejection code on the laboratory information system, and descriptive analysis performed using Microsoft Excel. Delay in diagnosis was calculated for patients who had a missed diagnostic opportunity registered between January 2013 and December 2015 by means of a patient linking-algorithm employing demographic details.ResultsBetween 2010 and 2015, 2 178 582 samples were registered for HIV PCR testing of which 6.2% (n = 134 339) failed to yield either a positive or negative result, decreasing proportionally from 7.0% (n = 20 556) in 2010 to 4.4% (n = 21 388) in 2015 (p<0.001). Amongst 76 972 coded missed diagnostic opportunities, 49 585 (64.4%) were a result of pre-analytical error and 27 387 (35.6%) analytical error. Amongst 49 694 patients searched for follow-up results, 16 895 (34.0%) had at least one subsequent HIV PCR test registered after a median of 29 days (IQR: 13–57), of which 8.4% tested positive compared with 3.6% of all samples submitted for the same period.ConclusionsRoutine laboratory data provides the opportunity for near real-time surveillance and quality improvement within the EID program. Delay in diagnosis and wastage of resources associated with missed diagnostic opportunities must be addressed and infants actively followed-up as South Africa works towards elimination of mother-to-child transmission.

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False-positive HIV DNA PCR testing of infants: Implications in a changing epidemic

Cited by 33 publications

References 8 publications

HIV-1 Variants and Drug Resistance in Pregnant Women from Bata (Equatorial Guinea): 2012-2013

HIV-1 Variants and Drug Resistance in Pregnant Women from Bata (Equatorial Guinea): 2012-2013

False-negative post-18-month confirmatory HIV tests in HIV DNA PCR-positive children

Missed diagnostic opportunities within South Africa’s early infant diagnosis program, 2010–2015

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