细胞因子诱导的杀伤细胞治疗肿瘤的研究进展

肿瘤的过继细胞治疗是肿瘤生物治疗中最活跃的研究领域之一,细胞因子诱导的杀伤细胞(CIK)在肿瘤的治疗中逐渐成为焦点。CIK细胞是一群异质性细胞群,由多种细胞因子共同作用诱导而来,因其强大的增殖活性和杀瘤活性,非MHC限制性及低毒副作用等优点,自发现就得到了广泛的关注。目前CIK细胞已经用于恶性肿瘤的治疗,并有望成为恶性肿瘤综合治疗的新方向。本文就CIK的表型、扩增、抗肿瘤作用机制、临床应用和副作用等方面的进展作一综述。     

Clinical experience with the delivery of thawed and washed autologous blood cells, with an automated closed fluid management device: CytoMate

BACKGROUND: Washing out of thawed autologous grafts, before reinfusion in poor‐prognosis cancer patients who undergo high‐dose chemotherapy, is desirable. The procedure allows for the reduction of infused dimethyl sulfoxide (DMSO) quantities and the performance of biologic controls on the infused cell product. STUDY DESIGN AND METHODS: Three‐hundred four patients were treated with intensified chemotherapy and autologous transplantation at a single institution. Fifty‐four of them received washed cell products, because three or more bags were to be reinfused. The recently available, closed, automated, and current good manufacturing practice–compliant device (CytoMate, Baxter Oncology) was used for this purpose. RESULTS: The performances of the device were similar to previously reported results, with greater than 75 percent CD34+ cell recovery. Neutrophil and platelet (PLT) recoveries were similar in the group of patients receiving washed cells and in the group of patients for whom cell products were extemporaneously thawed at the bedside. Adverse events that are typically reported after DMSO infusion were significantly less frequent and less severe in patients who received washed cells. Finally, the nurse staff on the transplant ward reported a decreased workload and more satisfactory procedure when infusing washed cell products. CONCLUSION: The CytoMate device allows for a significant reduction in DMSO infusion, with a diminished frequency and severity of immediate side effects and does not compromise neutrophil or PLT engraftment.     

细胞因子诱导的杀伤细胞应用于中晚期肾癌患者的护理

目的:评价细胞因子诱导的杀伤细胞应用于中晚期肾癌患者中的护理。方法:收集2009年10月～2011年10月我科收治的51例中晚期肾癌患者,对其治疗期间的健康宣教、抽血护理、心理护理、回输前后护理、不良反应观察及预防等方面进行回顾性分析。结果:本组51例患者中完全缓解0例,部分缓解11例,稳定27例,进展13例。其中1例发生高热(39℃以上),经口服吲哚美辛片25 mg后体温恢复正常;13例发生低热(37.6～38.5℃),未经特殊处理,自行好转。结论:接受细胞因子诱导的杀伤细胞治疗中晚期肾癌患者经合理而恰当的护理对患者的治疗有一定影响,值得临床推广应用。     

Analysis of adverse events following the treatment of autologous cytokine-induced killer cells for adoptive immunotherapy in malignant tumour sufferers

Background: Passive immunization strategies are under investigation as potential disease-modifying therapies for Alzheimer's disease (AD). Current approaches, based on data demonstrating behavioral improvement and reduced pathology in transgenic animal models, have focused exclusively on immune targeting of β-amyloid. Objective: To examine immunization strategies for AD. Methods: A review of relevant publications. Results/conclusions: Preliminary results from three Phase II trials suggest both the promise and the need to exercise caution with this method of immunotherapy. The strategies used were distinct, using monoclonal N-terminal, central epitope, and polyclonal antibodies to maximize the efficacy and safety of each approach. The tested compounds are moving into Phase III trials for mild to moderate AD. We await the discoveries that from these studies that may yield the first disease-modifying therapy for AD.     

Interactions between dendritic cells and cytokine-induced killer cells lead to an activation of both populations.

Dendritic cells (DCs) are major antigen-presenting cells. They are capable of capturing and processing tumor antigens, expressing lymphocyte costimulatory molecules, and secreting cytokines to initiate immune responses. Here, the authors tested the effect of cytokine-induced killer (CIK) cells, a population that includes CD3+CD56+ cells (natural killer T cells), with regard to their capacity to immunomodulate DCs. Cytokine-induced killer cells were cocultured with autologous DCs generated from peripheral blood mononuclear cells. Expression of markers typical for both populations was measured using flow cytometry, and secretion of interleukin (IL)-12 was determined using enzyme-linked immunosorbent assays. Cytotoxicity assays were performed to investigate the role of IL-12 and the importance of cell-cell interactions. Considering this, receptors for IL-12 and CD40 were blocked and cocultures were performed with cell culture inserts. Coculture of CIK cells led to a significant increase of DC-specific, costimulatory, and antigen-presenting molecules in DC cultures. In addition, coculture resulted in a dramatically increase of IL-12 secretion by DCs and to a significant increase in cytotoxic activity of CIK cells toward carcinoma cells. Blockage of IL-12 uptake decreased the cytolytic activity of CIK cells. Cytokine secretion was shown to be important for activation of CIK cells, and also cellular interactions between DCs and effector cells caused a higher cytolytic capacity. Interactions between DCs and CIK cells caused changes in the surface molecule expression of both populations, led to an increase of IL-12 secretion, and rendered an improved cytotoxic activity. The natural killer T cell subpopulation seems to be responsible for this effect. Therefore, coculture of DCs with CIK cells may have a major impact on immunotherapeutic protocols for patients with cancer.     

Evaluation of an automated cell processing device to reduce the dimethyl sulfoxide from hematopoietic grafts after thawing

BACKGROUND: The direct transfusion of thawed hematopoietic progenitor cells (HPCs) is associated to transfusion-related side effects that are thought to be dose-dependent on the infused dimethyl sulfoxide (DMSO). Both the effectiveness of a fully automated cell processing device to washing out DMSO and the effects of DMSO elimination over the recovered cells were evaluated. STUDY DESIGN AND METHODS: Twenty cryopre-served peripheral blood HPC bags (HPC apheresis [HPC-A]) were thawed and processed for washing with an automated cell-processing device. Viability, colony-forming units (CFUs), and absolute count of recovered cells were evaluated by flow cytometry immediately after washing as well as at different times after washing and compared with a sample taken just after thawing (control) but maintained at 4 degrees C. DMSO content was measured by high-performance liquid chromatography and the osmolarity with an osmometer. RESULTS: The median recovery of viable total nucleated cells, viable CD34+ cells, and CFU colonies was 89 (range, 74-115), 103 (range, 62-126), and 91 percent (range, 46%-196%), respectively, in the washing group. Recovery of viable CD3+ cells was 97 percent (range, 42%-131%) and CD14+ cells was 82 percent (54%-119%). The percentages of DMSO elimination and osmolarity reduction were 98 (range, 96-99) and 90 percent (range 86%-95%), respectively. Moreover, elimination of the cryoprotectant improved CFU count, viability, and cell recoveries along the time when compared with the control group. CONCLUSION: Washing out DMSO in thawed HPC-A by use of this approach is safe and efficient in terms of recovery and viability of nucleated and progenitor cells. Additionally, the removal degree of DMSO is very high and therefore might ameliorate the transfusion-related side effects.     

Lymphokine-activated killer cell generation and recovery. Comparison of an automated cell processing device and a manual procedure

This report describes the separation or processing of leukapheresis-derived peripheral blood mononuclear cells, their culture in the presence of interleukin-2 (IL-2) to generate lymphokine-activated killer (LAK) cells, and the harvest of LAK cells using the Du Pont SteriCell processor and culture containers. The report compares this automated closed system to the standard National Cancer Institute (NCI) manual protocols. Lymphocytes (approximately 2.0 x 10(10)) were harvested on the Cobe 2997 blood cell separator for each set of experiments. A set of experiments using automated Ficoll-Isopaque (FI) separation and a set of experiments using an automated wash for platelet reduction were compared to the respective manual methods. SteriCell culture containers were compared to roller bottles, and automated harvest was compared to manual harvest. The cytolytic activity of LAK cells was assayed against that of Daudi cells in a standard 51Cr release assay. The cytolytic activity of LAK cells prepared by a manual method and by the automated SteriCell method are equivalent. The manual and SteriCell FI separation procedures were substantially equivalent. The SteriCell harvest method gave higher recoveries than the manual harvest method (p = 0.04 and p = 0.07), but the overall recovery of LAK cells was not significantly different. Differential counts on the products were similar. Platelet reduction by the SteriCell automated wash procedure was greater than that by the manual procedure (p = 0.05). The SteriCell system represents an acceptable alternative to the manual methods for LAK cell generation and recovery.     

The rise of human stem cell-derived natural killer cells for cancer immunotherapy

Introduction: Natural killer (NK) cell therapy has been proven to be safe and clinically effective for the treatment of multiple cancers, in particular blood cancers. Most of the clinical trials use primary NK cells from peripheral blood or umbilical cord blood, or NK-92 cells. Each cell source is confined by limitations, such as donor dependence, low persistence in vivo, and its difficulty to genetically modify. Thus, there is an urgent need to explore novel NK cell sources for clinical use.

Areas covered: This article highlights the recent progress in utilizing stem cell-derived NK cells as anticancer therapies and strategies to improve their antitumor activities.

Expert commentary: Stem cell-derived NK cells are homogenous, easy to genetically modify on a clonal level, and can be expanded to clinical scale. They may therefore arise as an ideal population for developing off-the-shelf, standardized adoptive NK cell therapeutic products.     

自然杀伤细胞在血液肿瘤免疫治疗中的应用及研究进展

自然杀伤(NK)细胞为机体固有免疫系统效应细胞,无需抗原预先致敏即可识别并杀伤肿瘤等异常细胞,参与免疫监视功能,移植物排斥反应与自身免疫疾病的发生.NK细胞对血液肿瘤细胞的杀伤活性主要取决于其细胞表面活化性受体与抑制性受体分别识别血液肿瘤细胞相应配体后产生的信号强度的综合.随着对NK细胞对肿瘤细胞杀伤作用机制的深入研究,以NK细胞为基础的血液肿瘤过继免疫治疗备受关注.     

2种个性化音乐疗法对改善ICU患者焦虑状况的对比研究

目的通过2种不同音乐疗法对改善重症监护室（ICU）患者焦虑状况的比较，探索最佳个性化音乐的设置，提高音乐治疗的效率。方法将入住ICU超过1周的患者60例，按入院先后顺序随机分为实验组和对照组各30例，2组除常规护理外，实验组每日播放不同的音乐曲目，且不定时播放；对照组每日播放固定的音乐曲目，并定时播放。2组干预前后，分别采用焦虑自评量表（SAS）测评患者焦摩隋绪并进行比较。结果实验组干预后SAS的评分下降明显，与干预前评分比较差异有统计学意义（P〈0．01），对照组干预后SAS的评分也降低，但与干预前比较差异无统计学意义（P〉0．05）；干预结束后，实验组的SAS评分低于对照组，其差异有统计学意义（P〈0．01）。结论非固定曲目不定时播放的音乐疗法，对减轻ICU患者焦虑的效果优于固定曲目定时播放。     

Evaluation of an automated microbiologic blood culture device for detection of bacteria in platelet components

BACKGROUND: Automated culture methods have been used by several investigators to detect bacterial contamination of cellular blood components. We investigated several factors affecting detection by automated culture of bacteria in platelet concentrates (PCs).These factors included the initial contamination level in PCs, the PC sample volume, the PC sample time, and the white cell level in relation to bacteria levels in the PCs. STUDY DESIGN AND METHODS: Staphylococcus epidermidis or Escherichia coli was inoculated into freshly prepared PCs or white cell-reduced PCs to yield colony-forming unit (CFU) levels of 10, 1, or 0.1 per mL. At the time of inoculation (t=0) and at t=6, t=24, and t=48 hours, 0.5, 1.0, and 2.0 mL samples of the contaminated PCs were transferred into culture bottles. The presence of bacteria in the culture bottles was subsequently monitored by an automated blood culturing instrument. Bacteria levels in the PC at the time of first automated culture detection were determined by quantitative plating. RESULTS: E. coli was detected in 92 percent of experiments when 1.0- or 2.0-mL samples were taken at t=6 hours. At t=24 hours, 100-percent detection was observed with all tested inoculation volumes; however, by that time,>10(7) CFU per mL of bacteria were present in every PC. For S. epidermidis, 89 percent and 83 percent of contaminated PCs were detected with a t=24 hour sampling time and 2.0- or 1.0-mL sampling volume. Seven of 36 PCs with a 2.0-mL sampling volume and 10 of 36 PCs with a 1.0-mL sampling volume contained>10(6) CFU per mL of S. epidermidis at the time of first detection. CONCLUSION: Data from this preliminary evaluation suggest that sampling times of 24 hours or more would be necessary to provide confidence in detection of E. coli or S. epidermidis in PCs using this culture method.     

Evaluation of the XE-5000 for the automated analysis of blood cells in cerebrospinal fluid

ObjectivesCounting of cells in cerebrospinal fluid is an important clinical laboratory test and elevated white blood cell counts in cerebrospinal fluid are frequently seen in CNS disorders. Quantification of red blood cell concentrations in CSF may help to interpret certain diagnostic constellations and may result from subarachnoid haemorrhage, surgical procedures or contamination due to traumatic puncture. Table top analyser XE-5000 (Sysmex, Norderstedt, Germany) offers, beside its use as a haematology analyser, a protocol for the quantification of red and white blood cells in body fluids such as CSF including the differentiation between polymorphonuclear and mononuclear cells. A detection limit of 1 cell/mm³ would render this device suitable for automated CSF analysis.Design and methodsWhite blood cell counting was compared between Fuchs–Rosenthal counting chamber and XE-5000 in 273 routinely collected lumbar and ventricular CSF samples. Red blood cell counting was compared between UF-100 and XE-5000. Differentiation was performed on a slide stained after Pappenheim and compared to the differential count of the XE-5000.ResultsLinearity was established between 1 and 10,000 cells/mm³ for white blood cells and between 1000 and 1 ? 10³ particles/mm³ for red blood cells. Functional sensitivity was established at 20 cells/mm³ for white blood cell counting and at 1000 particles/mm³ (lowest reported concentration) for red blood cell counting. When comparing between microscopic and automatic white blood cell counts no statistically significant slope and offset were detected in lumbar CSF samples while a significant slope and offset were detected when comparing ventricular CSF samples. Most patients were classified correctly according to their WBC count (non-pathologic, mildly, moderately, and highly elevated) by both methods although more patients had pathologic white blood cell counts on XE-5000. A significant slope and offset were detected when comparing red blood cell counts between UF-100 and XE-5000.ConclusionsIn summary despite its high imprecision at low white blood cell counts (< 20 particles/mm³) most patients were classified correctly and therefore XE-5000 is suitable for automated quantification of white blood cells in cerebrospinal fluid in a defined diagnostic setting. This could significantly improve automation in the relatively time- and manual work-intensive field of cerebrospinal fluid diagnostics. However, careful review of plausibility of the results continues to be compulsory.     

Density gradient separation of peripheral blood stem cells: comparison of an automated cell processing device and manual methods

Peripheral blood stem cells were collected from normal donors by leukapheresis on a cell separator. The leukapheresis product contained 1.5 x 10(10) mononuclear cells (MNCs) and was divided into two aliquots that underwent either automated or manual density gradient separation with ficoll-hypaque and subsequent washing. In the automated process, recovery of MNCs was 85 percent, reduction in platelet content was 64 percent, and the final hematocrit (Hct) was less than 1 percent. The manual separation resulted in 76-percent MNC recovery, a 79-percent reduction in platelet content, and a final Hct of less than 1 percent. The purified MNCs were then placed in methylcellulose culture at a concentration of 4 x 10(5) MNCs per mL. Quadruplicate 1-mL aliquots were cultured, and colonies were counted and classified on Day 14. Comparison of automated and manual ficoll-hypaque separations demonstrated no differences in the total, erythroid, or granulocyte-macrophage colony numbers. The cell processor used is fast, reliable, uncomplicated, and provides a sterile product containing progenitor cells that are not adversely affected by the automated ficoll-hypaque separation.     

Impact of the use of an automated chest-compression device on airway management during out-of-hospital cardiopulmonary resuscitation: the PLAINT study

Introduction

Automated chest-compression devices (ACCDs) have recently been proposed in the management of out-of-hospital cardiac arrest (cardiopulmonary resuscitation, CPR). During CPR, it is still unknown whether the ACCD or intubation is to be first implemented. Knowing the impact of an ACCD on intubation conditions could strongly contribute to determine the best sequence. Therefore, we undertook an experimental study on intubation conditions on a mannequin with or without the use of an ACCD.

Methods

Emergency physicians and nurses experienced in the field of cardiac-arrest management (including orotracheal intubation) were randomly assigned to three scenarios to intubate a mannequin: patient lying on the floor without an ACCD (group 1), patient lying on the floor with the ACCD switched off (group 2) or switched on (group 3).The primary end point was intubation time. Estimated intubation difficulty evaluated on a visual analogue scale (VAS), ranging from 0 (easy) to 100 (impossible), number of attempts, Cormack grade and dental traumatisms associated with the intubation procedure were secondary end points.

Results

A total of 44 operators performed the intubation. Times to intubation were 14 (11–22), 15 (10–21) and 18 (15–27) s for groups 1, 2 and 3, respectively. The VAS difficulties were 12 (5–25), 15 (10–25) and 15 (5–21), respectively. Intubation conditions did not differ between the ‘without an ACCD group’ and the ‘switched-off ACCD group’. In the ‘switched-on ACCD group’, time to intubation was significantly increased in comparison with groups 1 and 2 with a median difference of 4 (1–10) and 3 (0–7) s, respectively. The VAS difficulty was also significantly increased in the ‘switched-on ACCD group’. Other secondary end-point criteria did not differ between the three groups.

Conclusion

Due to the major role of compression during CPR, we suggest that the ACCD should not be systematically switched off for routine intubation.     

Modification of chemokine receptor expression to enhance levels of trafficking receptors on autologous cytokine-induced killer cells derived from patients with colorectal cancer

Cytokine-induced killer (CIK) cells have achieved therapeutic benefit in treatment of solid tumors in clinic. However, some patients show no response after CIK treatment. Animal assays have shown that successful infiltration of CIK cells to the tumor sites could affect the outcome. Chemokines play important roles in lymphocyte trafficking. Understanding the molecular mechanism of chemokines in the process of CIK cell homing is important for further modification of CIK therapy. In this study, we investigated the spectrum of chemokine ligands in the colorectal cancer sites and observed that chemokine ligands CCL20 and CXCL10 were overexpressed in the CRC tumor tissues compared with adjacent tissues. Although the corresponding receptors CCR6 and CXCR3 increased on CIK cells compared with PBMCs, their expression on CIK cells derived from CRC patients had lower levels than healthy donors, which might be a limited factor for autologous-CIK cells trafficking to tumor site. Importantly, stimulation with chemokines CCL20 and CXCL10 promotes the expression levels of CCR6 and CXCR3 on CIK cells, thus augmenting the relative migration of CIK cells in vitro. Our results suggest that modification of surface chemokine receptors may enhance the homing ability of CIK cells for better therapeutic achievements.     

The use of an insuflon device for the administration of G-CSF in pediatric cancer patients

In pediatric oncology, granulocyte colony-stimulating factor (G-CSF) is applied with the aim of shortening neutropenic periods after chemotherapy and for mobilization of peripheral blood stem cells for apheresis procedures. G-CSF is administered, subcutaneously or intravenously, on a daily basis. An insuflon device for the administration of G-CSF was used in 29 patients for 93 G-CSF periods. Retrospective evaluation shows that this administration route is feasible, safe and preferred by young children rather than by teenagers with cancer.     

Out-of-hospital use of an automated chest compression device: facilitating access to extracorporeal life support or non-heart-beating organ procurement

ObjectiveThe aim of the study was to assess the ease-of-use, safety, and usefulness of an automated external chest compression device for cardiopulmonary resuscitation.MethodsAdults with out-of-hospital cardiac arrest (OHCA) were included prospectively. The emergency medical services (EMS) in a large suburb northeast of Paris (France) recorded data for standard criteria for EMS care for CA and specific criteria on device use—application time, ease of application and use (visual analog scale score: 0, impossible; 5, very easy), technical incidents, and clinical complications.ResultsWe attended 4868 OHCA patients (January 2005 to April 2010) and used the device in 285 patients (6%) (212 males [74%], 73 females [26%]; median age, 56 [43-70] years). Results (medians with 25-75 percentiles) were as follows: time to apply device, 30 seconds (20-60); ease of application and activation, 5 (4-5) and 5 (5-5), respectively; duration of use, 30 (20-41) minutes; return to spontaneous circulation (ROSC), 76 patients (27%); and time to ROSC, 19 (12-32) minutes after placement. Twenty-seven patients (9%) with refractory CA benefited from extracorporeal life support. Overall, 32 patients were alive after 24 hours, 11 at 7 days, and 3 at 1 month. An additional 23 patients (8%) with refractory CA were selected for non–heart-beating kidney procurement. Ten patients were used to harvest kidneys and 15 were transplanted. There were 21 technical incidents (7%) and 19 clinical complications (7%).ConclusionThe device was easy to use in routine emergency practice and of particular value in facilitating access to extracorporeal life support or non–heart-beating organ procurement. These uses should be itemized in all OHCA studies.     

Development and evaluation of an automated dye-binding assay for protein in cerebrospinal fluid

Addition of sodium dodecyl sulfate (SDS) to Coomassie Brilliant Blue reagent equalizes the binding variability of the dye to various proteins and markedly improves the accuracy of quantification of protein in cerebrospinal fluid. In the presence of SDS, the absorption spectrum and the absorption maximum are affected by reaction time and temperature, age of the dye preparation, and protein constituent. I automated this procedure, to optimize precision, enable use of a smaller sample, decrease hands-on time, maintain consistency in the time of reading, and avoid carryover. The results (y) compared well with those of the aca (x), with a Deming de-biased regression equation of y = 0.991x + 14.1 mg/L, Sy.x = 33.4 mg/L. The within-run and between-run precision (CV) was less than 2.5% and less than 4.5%, respectively. Commonly used antibiotics, flucytosine, or amphotericin B do not interfere. This automated procedure is fast and accurate and requires only 10 microL of sample.     

Improved neurologically intact survival with the use of an automated, load-distributing band chest compression device for cardiac arrest presenting to the emergency department

ABSTRACT: INTRODUCTION: It has been unclear if mechanical cardiopulmonary resuscitation (CPR) is a viable alternative to manual CPR. We aimed to compare resuscitation outcomes before and after switching from manual CPR to load-distributing band (LDB) CPR in a multi-center emergency department (ED) trial. METHODS: We conducted a phased, prospective cohort evaluation with intention-to-treat analysis of adults with non-traumatic cardiac arrest. At these two urban EDs, systems were changed from manual CPR to LDB-CPR. Primary outcome was survival to hospital discharge, with secondary outcome measures of return of spontaneous circulation, survival to hospital admission and neurological outcome at discharge. RESULTS: A total of 1,011 patients were included in the study, with 459 in the manual CPR phase (January 01, 2004, to August 24, 2007) and 552 patients in the LDB-CPR phase (August 16, 2007, to December 31, 2009). In the LDB phase, the LDB device was applied in 454 patients (82.3%). Patients in the manual CPR and LDB-CPR phases were comparable for mean age, gender and ethnicity. The mean duration from collapse to arrival at ED (min) for manual CPR and LDB-CPR phases was 34:03 (SD16:59) and 33:18 (SD14:57) respectively. The rate of survival to hospital discharge tended to be higher in the LDB-CPR phase (LDB 3.3% vs Manual 1.3%; adjusted OR, 1.42; 95% CI, 0.47, 4.29). There were more survivors in LDB group with cerebral performance category 1 (good) (Manual 1 vs LDB 12, P=0.01). Overall performance category 1 (good) was Manual 1 vs LDB 10, P=0.06. CONCLUSIONS: A resuscitation strategy using LDB-CPR in an ED environment was associated with improved neurologically intact survival on discharge in adults with prolonged, non-traumatic cardiac arrest.     

Evaluation of the diagnostic performance of an oral fluid screening test device for substance abuse at traffic controls

IntroductionThe aim of this study was to evaluate the analytical performance of the Kite Biotechnology Oral fluid (OF) screening test device, which is used for roadside screening of cannabis, opiates, amphetamines, methamphetamine, 3,4-methylenedioxymethamphetamine (MDMA), cocaine and benzodiazepines by comparing samples with matched plasma samples, analysed via liquid chromatography–tandem mass spectrometry (LC-MS/MS) for confirmation.MethodsOF and plasma samples were obtained simultaneously from a total of 100 subjects. OF samples were analysed by OF screening test based on immunochromatography. The OF screening test cut-off values were 50 ng/mL for amphetamines (d-amphetamine) and methamphetamine/MDMA (d-methamphetamine), 30 ng/mL for cocaine (benzoylecgonine), 40 ng/mL for opiates (morphine), 20 ng/mL for benzodiazepines (nordazepam), and 25 ng/mL for cannabis (Δ⁹-tetrahydrocannabinol). LC-MS/MS method validation was performed according to the CLSI C62-A recommendations with the following parameters: matrix effect, lower limit of quantification (LLOQ), linearity, intra-day and inter-day precision and accuracy.ResultsThe overall specificity, accuracy and negative predictive values (NPV) were acceptable and met the DRUID standard of >80%. The OF screening test device showed good sensitivity for cocaine, amphetamines and opiates, whereas it indicated poor sensitivity for methamphetamine/MDMA (66.7%) and failed to detect cannabis and benzodiazepines.ConclusionThe present study is the first report to evaluate the Kite Biotechnology OF screening test device. The diagnostic performance of the OF screening test device was acceptable for opiates, cocaine and amphetamines, but it was insufficient for methamphetamine/MDMA, benzodiazepines and cannabis because of sensitivity issues.