Evaluation of a near-patient diagnostic platform for G6PD – Webinar

This presentation titled “Evaluation of a near-patient diagnostic platform for G6PD” was given by Dr. Michael Cotten in a live stream on July 24, 2020, hosted by the Pediatric Academic Societies 2020 PAS Summer Webinar Series – Neonatal Hematology & Bilirubin Metabolism.

Funding for this project: NIH/NICHD Small Business Innovation Research (SBIR) Phase IIB: R44HD072853-06

FINDER and associated assays are not available for sale in the US.

This presentation is based on the abstract that was accepted for an oral talk at PAS 2020:

Background: Glucose-6-phosphate dehydrogenase (G6PD) deficiency is an inherited enzymopathy which can cause antenatal, perinatal and later disease. Neonates with undetected G6PD deficiency are at risk for extreme hyperbilirubinemia. The American Academy of Pediatrics recommends G6PD testing for jaundiced newborns under phototherapy whose family history or ethnic or geographic origin suggest likelihood of G6PD deficiency, or whose response to phototherapy is poor. Turn-around time (TAT) for send-out G6PD testing is 2-3 days and requires ≥ 1mL whole blood. Manual, qualitative assays are used for neonatal testing in some centers. An automated, quantitative, low blood volume platform for G6PD testing could facilitate G6PD deficiency detection.

Objective: Evaluate a G6PD testing platform that uses 50 µL whole blood samples with TAT of 15 minutes.

Design/Methods: Three evaluations were done: #1) new platform compared with current standard; #2) finger stick compared with venipuncture samples on the new platform, and #3) precision tests of samples across 3 clinical sites on the new platform.

For #1 and #2, 50 adults provided venipuncture (Li Heparin 2mL BD Vacutainer®) and finger stick capillary (Li Heparin Sarstedt 100µL Microvette®) whole blood samples. To cover the testing range in #1, 1 affected venous sample (~3 U/gHb) from BioIVT (Westbury, NY) was used to make 10 contrived samples. In #1, duplicate samples were run on the gold standard Pointe Scientific (PS, Canton, MI) G6PD assay with hemoglobin concentration normalization on the Roche Cobas Mira Plus (Roche Diagnostics, Switzerland) and 50 µL samples were run on the Baebies FINDER G6PD assay (R44HD072853).

For #2, 50 µL venipuncture and capillary samples were compared on FINDER.

For #3, precision was assessed using venipuncture blood procured from BioIVT, sent to 3 sites every day for 3 days, and tested on FINDER (n=5 per day) by multiple users.

Results: Time to result on FINDER was ~15 minutes and ~1h on standard. For evaluation #1, R-value = 0.841 between FINDER and standard. For #2, venipuncture and capillary samples’ FINDER values had a mean difference of 5.6%, which is within the reproducibility range of 6.2% between-sites variation observed in evaluation #3.

Conclusion(s): Using 50 µL samples, FINDER G6PD results were available within 15 minutes, correlated well with current methodology, had similar results for capillary and venous samples, and between-site and user results were similar. These capabilities open the possibility for pre-discharge G6PD testing.

AUTHORS/INSTITUTIONS: C.M. Cotten, K.A. Fisher, Pediatrics, Duke University, Durham, North Carolina; S.D. Kicklighter, WakeMed Medical Center, Raleigh, North Carolina; M. Nock, Pediatrics, Neonatology, Rainbow Babies and Children’s Hospital, Cleveland, Ohio; R. Sista, C. Roberts, V. Pamula, Baebies, Durham, North Carolina

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