Long-term Experience with Rapid Screening for Platelet Bacterial Contamination in a High-volume Transfusion Service.

Bacterial sepsis after platelet transfusion is a major cause of transfusion-transmitted infections in the US. The Food and Drug Administration (FDA) recommends performing quality control for platelet bacterial detection on days 4 and 5 before platelet transfusion. We assessed the feasibility of implementing the Pan Genera Detection (PGD) test, an FDA-approved immunoassay for platelet bacterial detection, for the primary and secondary bacterial screening of platelet units in a high-volume setting. Records were reviewed from January 2010 through December 2015. All apheresis platelets underwent primary screening by using culture methods. Additional screening with the PGD test was performed daily until February 2013, when PGD testing of apheresis platelets was performed at the start of storage day 5. In April 2015, PGD testing of apheresis platelet products was performed at the start of storage day 4. Post-storage pooled whole blood-derived platelets were screened by using the PGD test on the day of use. During the 6-year study period, 16,839 PGD tests were performed. If the PGD test was reactive, repeat PGD testing was performed. In cases of repeat reactivity, units were quarantined and cultured. Initially, 42 (0.25%) tests were reactive; 26/42 (61.91%) were repeatedly reactive and resulted in an overall PGD repeat reactivity rate of 0.15%. Only one sample grew coagulase-negative Staphylococcus No transfusion-transmitted infections were reported. The PGD bacterial detection assay was feasible and efficient in our high-volume transfusion service.

PIFA PLUSS P4 Assay for Screening of Heparin-Induced Thrombocytopenia.

BACKGROUND: The PIFA PLUSS PF4 Rapid Assay (PIFA) is a rapid screening test used for the diagnosis of heparin-induced thrombocytopenia (HIT). OBJECTIVE: To determine the usefulness of this assay as a screening method in our institution. METHODS: A total of 159 specimens from patients with suspected HIT were included in our study. We simultaneously performed PIFA assay and confirmatory polyspecific enzyme-linked immunosorbent assay (ELISA). We subjected most of the specimens with false-negative results to serotonin release assay (SRA). RESULTS: The initial sensitivity and specificity of the PIFA assay were calculated as 27.3% and 71.5%, respectively. A total of 12 of 16 false-negative results were further tested using the SRA method. The revised sensitivity and specificity were 50.0% and 73.5%, respectively. CONCLUSIONS: Despite its appealing feature of yielding rapid results, the PIFA assay is inadequate as a sole screening test for HIT because of its high probability of missing many true cases of HIT.