Specimen Temperature Detection on a Clinical Laboratory Pre-Analytic Automation Track: Implications for Direct-from-Track Total Laboratory Automation (TLA) Systems.

Clinical laboratory regulations require temperature monitoring of facilities, reagent and specimen storage, as well as temperature-dependent equipment. Real-time specimen temperature detection has not yet been integrated into total laboratory automation (TLA) solutions. An infrared (IR) pyrometer was paired with a complementary metal oxide semiconductor (CMOS) laser sensor and connected to an embedded networked personal computer (PC) to create a modular temperature detection unit for closed, moving clinical laboratory specimens. Accuracy of the detector was assessed by comparing temperature measurements to those obtained from thermocouples connected to battery-operated data loggers. The temperature detector was then installed on a pre-analytic laboratory automation system to assess specimen temperature before and after processing on an integrated thawing and mixing (T/M) robotic workcell. The IR temperature detector was able to accurately record temperature of closed, moving specimens on a pre-analytic automation system. The effectiveness of the T/M workcell was independently verified using the temperature detector. Specimen reroute on the pre-analytic automation track was identified as a potential risk for frozen specimens being inadvertently delivered to future, connected instrumentation. Automated IR temperature detection can be used to verify specimen temperature prior to instrument loading and/or sampling. Such systems could be used to prevent frozen specimens from being inadvertently loaded onto analytical instrumentation in TLA solutions.

Identification and Characterization of EDTA Test Strip Interfering Substances Using a Digital Color Detector.

BACKGROUND: Rapid test strips for ethylenediaminetetraacetic acid (EDTA) can be used to verify correct specimen types for clinical assays which require, or cannot be performed on, plasma collection tubes containing EDTA anticoagulant. As the test strip reaction chemistry is based on a color change induced by chelation of bismuth from a xylenol orange complex, we hypothesized that any agent capable of chelating bismuth might induce false positive test strip reactivity. The present study was therefore designed to evaluate the potential for test strip interference by chelating agents commonly used in the treatment of trace and heavy metal toxicity. METHODS: A digital color detector mounted on a 3D-printed test strip holder was used to quantitatively assess test strip reactivity and evaluate concentration-response relationships of eight commercially available chelating agents. RESULTS: This approach revealed the following rank-order potency: K2EDTA = Na2EDTA > ethylene glycol tetra-acetic acid (EGTA) > dimercaptosuccinic acid (DMSA) > 2,3-dimercapto-1-propanesulfonic acid (DMPS) > penicillamine (PEN). Both deferoxamine (DEF) and alpha lipoic acid (ALA) were non-reactive at 10 mM concentrations. CONCLUSIONS: These experiments demonstrate that multiple substances can induce EDTA rapid test strip reactivity, but only at concentrations higher than might be expected during therapeutic chelation therapy. These agents are therefore unlikely to cause false positive results in routine clinical laboratory specimens.

Evaluation of test strips for the rapid identification of ethylenediaminetetraacetic acid (EDTA) specimens.

BACKGROUND: Identification of specimens that contain ethylenediaminetetraacetic acid (EDTA) is frequently necessary when investigating potentially mislabeled or improperly collected specimens. OBJECTIVE: To evaluate the performance of rapid EDTA detection test strips in clinical specimens. METHODS: We applied specimens to test strips designed to detect EDTA (QUANTOFIX EDTA) using a pipet (drop mode). Reactions were scored visually on a scale from red (no EDTA) to orange (low/indeterminate EDTA) to yellow (contains EDTA). RESULTS: Test strips reliably identified specimens from EDTA-containing tube types. Although test strips did not detect strong reactivity in other specimens, tubes containing NaFl/K-oxalate produced an orange (low/indeterminate EDTA) reaction. Bismuth and citrate levels were higher in specimens after we dipped test strips into solution (dip mode). CONCLUSIONS: Test strips detected the presence of EDTA in concentrations found in EDTA-containing primary tubes. Test strips were less effective in evaluating low-level EDTA concentrations expected with intravenous line contamination or backflow. Indeterminate reactions required further investigation. Dip mode can produce analytical problems for assays that measure (or are interfered by) the contents of test strips.