Diagnostic Performance of a New Rapid Lateral Flow Immunoassay in Patients Suspected of Heparin-Induced Thrombocytopenia and Its Clinical Consequences.

We prospectively evaluated the diagnostic accuracy of a new rapid assay (STic Expert HIT) alone or in combination with a clinical score in 90 HIT-suspected patients. The 4Ts score was calculated, and ELISA and serotonin-release assay (SRA) were performed; the average time taken for test results were 2 and 5 days for ELISA and SRA, respectively. The STic test was performed in our laboratory as an evaluation exercise and the result was available in 1 hour, but results were not communicated to the clinicians so as to not influence management. Diagnostic performance of STic test was assessed, alone and in combination with 4Ts score. HIT was diagnosed in 19 patients. The sensitivity, specificity, and positive and negative predictive values for the STic test alone were 95%, 92%, 75%, and 98%, respectively, with an accuracy of 92%. The likelihood ratio for positive and negative results with the STic test was 11.2 and 0.06. The combination of the 4Ts score and the STic test results had a negative predictive value of 100% and a negative likelihood ratio of 0. The favorable performance of the STic test may allow for the rapid exclusion of HIT in combination with a low to intermediate pretest clinical probability. During the subsequent year, using the STic test in real time to rapidly exclude the diagnosis, we observed a 50% reduction in danaparoid administration in HIT-suspected patients.

Microbiological and physicochemical stability of fentanyl and sufentanil solutions for patient-controlled delivery systems.

The aim of this study was to assess the microbiological and physicochemical stability of opioid solutions containing fentanyl or sufentanil and thereby determine the feasibility of extending the expiration dates after mixing. Five systems containing fentanyl or sufentanil solutions at 50 microg/mL in portable patient-controlled analgesia (PCA) systems were filled and stored at room temperature for 14 days. They were sampled immediately after preparation, at day 3, and each day of the following weeks. Microbiological stability was assessed by performing sterility tests. The physicochemical study was performed by determining aspect, pH, and osmolality evolution. All samples were tested for appearance, change in color, and loss of concentration using an analytical method. There was no significant change in pH and osmolality values of any solutions. No precipitation or change in color was observed in any of the sample solutions. There was no significant loss of fentanyl or sufentanil over 14 days (4.3% and 4.1%, respectively). This study indicates that both drug solutions in the PCA systems are stable for a minimum of 14 days at room temperature.