Sym001, the First Recombinant Polyclonal Rhesus-D Specific Antibody Product, Was Safe and Well-Tolerated in a Placebo-Controlled Randomized Phase I Trial.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1987-1987
Author(s):  
Peter Hjelmström ◽  
Bengt Hallén ◽  
Ewa Lindenstroem ◽  
Shwe Gyaw
Keyword(s):  
Clinical Chemistry ◽  
Vital Signs ◽  
Primary Objective ◽  
Serious Adverse Events ◽  
Laboratory Findings ◽  
New Class ◽  
Severe Intensity ◽  
Clinically Significant ◽  
To Receive ◽  
Dose Dependent

Abstract Sym001 is the first compound in a new class of biopharmaceuticals in clinical development for the treatment of Immune Thrombocytopenic Purpura (ITP), and the prevention of hemolytic disease of the newborn by anti-D prophylaxis (ADP). Sym001 is a recombinant polyclonal antibody product consisting of 25 different anti-Rhesus D specific (RhD) antibodies. The primary objective of this clinical study was to assess the safety of Sym001 following a single intravenous (iv) dose in RhD+ and RhD− healthy male volunteers. Secondary objectives were to assess the potential immunogenicity and pharmacokinetic (PK) profile of Sym001. Fifty-nine RhD+ subjects and 18 RhD− subjects were randomized to receive up to 12.5 μg/kg or 75 μg/kg, respectively, in seven dose cohorts as shown below: Number of Subjects Cohort Dose (μg/kg) RhD+ Sym001 RhD+ Placebo RhD− Sym001 RhD− Placebo 1 0.25 5 2 0 0 2 1.0 5 2 0 0 3 4.0 7 2 7 2 4 12.5 7 2 7 2 5 25 7 2 0 0 6 50 7 2 0 0 7 75 7 2 0 0 Treatment with Sym001 was well tolerated and there were no serious adverse events (SAEs), no AEs of severe intensity and no AEs that resulted in discontinuation of the study in either the RhD+ or RhD− population. The frequencies of treatment-emergent AEs (TEAE), i.e. AEs occurring after drug administration, were similar among Sym001 and placebo treated subjects and there was no dose-dependent pattern of TEAEs. No significant decrease in mean hemoglobin level compared to baseline was observed at any dose level during the study, and no decrease in hemoglobin > 2 g/dL in any subject was seen. No other laboratory findings were suggestive of clinically significant hemolysis. In addition, no clinically significant changes in vital signs or electrocardiograms (ECGs) were observed, and there were no significant changes in clinical chemistry variables that did translate into SAEs or were assessed as being related to study medication. No immunogenicity to Sym001 was detected and analysis of PK is in progress. In conclusion, Sym001 was found to be safe and well-tolerated in healthy volunteers in doses up to 75 μg/ kg. Sym001 is now being evaluated in a red blood cell (RBC) challenge trial for the ADP indication and in a Phase II trial for treatment of patients with ITP.

An Analysis of Factors that Predict Hospital Readmission after Surgery for Perforated Appendicitis

2017 ◽  
Vol 83 (9) ◽  
pp. 991-995 ◽  
Author(s):  
Jeffanne E. Millien ◽  
Michael Townsend ◽  
Joshua Goldberg ◽  
George M. Fuhrman
Keyword(s):  
Hospital Readmission ◽  
Open Surgery ◽  
Demographic Data ◽  
Vital Signs ◽  
Perforated Appendicitis ◽  
Laboratory Findings ◽  
Percutaneous Abscess Drainage ◽  
Increased Risk ◽  
Perforated Appendix ◽  
Clinically Significant

We performed this study to develop an understanding of why patients were readmitted after appendectomy for perforated appendicitis. Patients who required surgery for perforated appendicitis during a recent five-year period were identified. We recorded the demographic data, length of symptoms, length of stay, vital signs, laboratory findings, surgical approach, length of surgery, time to readmission, length of readmission, and intervention required after readmission. We divided the cohort into two groups depending on whether the patient was readmitted. We used chisquared analysis and t test to determine differences between the two groups. We identified 86 patients, with 14 (16.3%) requiring readmission. The only factors that predicted readmission were longer appendectomy surgery (P = 0.03) and open surgery (P = 0.04). After readmission, one patient required reoperation, and two required percutaneous abscess drainage. The remaining 11 patients were readmitted for a median of two days, received intravenous fluids, and required no additional clinically significant management. Patients requiring longer and open surgery are at an increased risk for hospital readmission after resection of a perforated appendix. Efforts to reduce readmission will likely be most successful if hydration and brief periods of clinical observation can be arranged when necessary for patients after discharge from surgery.

Peritoneal Ultrafiltration and Serum Icodextrin Concentration during Dialysis with 7.5% Icodextrin Solution in Japanese Patients

2003 ◽  
Vol 23 (4) ◽  
pp. 356-361
Author(s):  
◽  
Kazuo Ota ◽  
Takashi Akiba ◽  
Toshiaki Nakao ◽  
Masaaki Nakayama ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Period ◽  
Negative Impact ◽  
Vital Signs ◽  
Major Change ◽  
Japanese Patients ◽  
Baseline Period ◽  
Serious Adverse Events ◽  
Laboratory Findings ◽  
Serum Osmolarity

♦ Objectives To assess the efficacy and safety of icodextrin in Japanese patients and to investigate the relationship between net ultrafiltration (UF) during the long dwell and plasma oligosaccharides. ♦ Design Open-labeled clinical trial involving patients on continuous ambulatory peritoneal dialysis (CAPD) receiving icodextrin during the 12-hour long dwell for 6 weeks, preceded by and followed by a 2-week baseline period and a follow-up period during which 1.36% glucose was used for the 8-hour long dwell. ♦ Setting A prospective, randomized multicenter study done in tertiary medical centers. ♦ Patients 18 stable patients on CAPD for 3 months or longer. ♦ Main Outcomes Measures Net UF (in milliliters), UF rate (in milliliters per hour), plasma oligosaccharides, serum osmolarity (in milliosmoles per liter), peritoneal absorption of icodextrin, and peritoneal clearances of icodextrin, creatinine, and urea were assessed. Adverse events, laboratory findings, and vital signs were also monitored. ♦ Results Long-dwell net UF (544.4 ± 96.7 mL at day 3, p < 0.001; 309.4 ± 60.7 mL at week 4, p < 0.001; and 391.7 ± 61.1 mL at week 6, p< 0.001) and UF rate (48.2 ± 38.8 mL/hour at day 3, p < 0.001; 26.9 ± 22.1 mL/hr at week 4, p < 0.002; and 35.3 ± 22.9 mL/hr at week 6, p = 0.0002) were significantly greater during the icodextrin period than at baseline (-25.9 ± 46.0 mL and -2.2 ± 22.1 mL/hr, respectively). Plasma oligosaccharides reached steady state within 2 weeks, remained stable during the treatment period, and returned to baseline level 2 weeks after discontinuation of icodextrin. Serum osmolarity increased during the use of icodextrin by approximately 5 mOsm/L. No statistically significant relationship was found between plasma oligosaccharides and net UF. Peritoneal absorption of icodextrin (36.3% ± 5.1% at day 3,42.2% ± 5.9% at week 4, and 38.0% ± 6.3% at week 6) and peritoneal clearance of icodextrin (10.1 mL/minute at day 3,10.1 mL/min at week 4, and 10.3 mL/min at week 6) showed no major change over time. Serum sodium and serum chloride both decreased by 5 mEq/L with icodextrin but remained within the normal range during the treatment period and returned to baseline levels immediately after discontinuation. No serious adverse events were observed during the study. ♦ Conclusion The results of this study do not support the hypothesis that an increased blood oligosaccharide level and the concomitant elevation in serum osmolarity have a negative impact on peritoneal UF. Therefore, the increase in plasma oligosaccharides appears to be too small to be of clinical significance.

Inhibition of Interleukin-6 (IL-6) Reverses Anemia In Patients with Advanced Non Small Cell Lung Cancer (NSCLC): Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Trial

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 640-640 ◽  
Author(s):  
Michael W. Schuster ◽  
James R Rigas ◽  
Sergey V Orlov ◽  
Branislav Milovanovic ◽  
Kumar Prabhash ◽  
...  
Keyword(s):  
Adverse Events ◽  
Clinical Chemistry ◽  
Controlled Trial ◽  
Safety Data ◽  
Primary Objective ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Reactive Protein ◽  
Grade 3 ◽  
Cancer Related Anemia

Abstract Abstract 640 Background: ALD518 is a humanized, desialyated anti-IL-6 antibody being developed for the treatment of cancer-related anemia, cachexia and fatigue. The primary objective of the study was to determine the efficacy and safety of ALD518 in patients with advanced NSCLC. Secondary objectives examined hematologic parameters. Methods: 124 patients with NSCLC, ECOG 0–3, weight loss in the preceding 3 months of >5% body weight, hemoglobin (Hb) >7g/dL, and C-reactive protein (CRP) >10mg/L were dosed. Patients were randomized to 1 of 4 groups (n~30/group). Placebo or ALD518 80mg, 160mg, or 320mg was administered intravenously every 8 weeks. Pts were followed up for 24 weeks. Data included hematologic parameters, clinical chemistry, CRP, D-dimer, lean body mass and adverse events (AEs). Quality of life data included the FACIT-F, FACT-L, and FAACT questionnaires. Data presented in this abstract relates to the safety and hematology results. Results: 29 pts completed the study treatments and evaluations, 38 failed to complete every visit, 52 died of progressive disease, and 5 withdrew because of adverse events. There were no dose limiting toxicities (DLTs), infusion reactions, or anti-idiotypic antibody responses to ALD518 observed in the study. 84 pts had serious AEs of which 1 was deemed to be possibly related to administration of ALD518 (rectal hemorrhage). The majority of the serious adverse events were due to progression of the NSCLC. Six patients had a CTC grade 4 change in laboratory safety data during the study. Four patients experienced a grade 4 hypercalcemia: 1 (3.6%), 2 (6.1%), and 1 (3.2%) in the ALD518 80mg, 160mg and placebo groups, respectively, and there was 1 patient with grade 4 GGT elevation (placebo) and 1 patient with grade 4 hypokalemia (ALD518 160mg). There were no treatment related differences in vitals sign or 12-lead ECG data. The mean (±SD) values for Hb, hematocrit (Hct), mean corpuscular Hb (MCH) and platelet counts are listed below: 38/93 pts treated with ALD518 and 10/31 given placebo had a pre-dose Hb =< 11g/dL. 24 of these pts on ALD518 and 7 of these pts on placebo remained in the study at week 4. 14/24 pts on ALD518 and 0/7 on placebo had raised their Hb from =< 11g/dL to >= 12g/dL. Conclusions: ALD518 increased Hb, Hct, MCH in NSCLC pts and raised Hb to >= 12g/dL in 58% of pts with a Hb =< 11g/dL at baseline. There was also a modest fall in platelet count observed in patients treated with ALD518 but no patients had a CTC grade 4 thrombocytopenia and only one patient (ALD518 160mg group) had a grade 3 thrombocytopenia at one time point. There were no major safety signals related to the administration of ALD518. Further study of ALD518 as a novel non-erythropoietic stimulating agent for cancer-related anemia is warranted. Disclosures: Schuster: Alder Biopharmaceuticals Inc: Honoraria. Rigas: Alder Biopharmaceuticals inc: Honoraria. Smith:Alder Biopharmaceuticals Inc: Employment.

scholarly journals Safety and Efficacy of Tocilizumab 4 or 8 mg/kg in Hospitalized Patients With Moderate to Severe COVID-19 Pneumonia: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Princy N Kumar ◽  
Jules Hernández-Sánchez ◽  
Sandra Nagel ◽  
Yuning Feng ◽  
Fang Cai ◽  
...  
Keyword(s):  
Clinical Status ◽  
Optimal Dose ◽  
Serum Concentrations ◽  
Open Label ◽  
Serious Adverse Events ◽  
End Points ◽  
Reactive Protein ◽  
Interleukin 6 Receptor ◽  
To Receive ◽  
Dose Dependent

Abstract Background Tocilizumab, an interleukin 6 receptor (IL-6R) antagonist monoclonal antibody, has shown efficacy in patients with COVID-19 pneumonia, but the optimal dose is unknown. Methods Patients hospitalized for moderate-to-severe COVID-19 pneumonia were randomized 1:1 to receive standard care treatment and 1 to 2 doses of intravenous tocilizumab 4 or 8 mg/kg (open-label). Primary pharmacokinetic and pharmacodynamic end points were serum concentrations of tocilizumab and soluble IL-6R (sIL-6R), IL-6, ferritin, and C-reactive protein (CRP), from baseline to day 60. The secondary end point was safety. Key exploratory efficacy end points included clinical status, time to discharge, mortality rate, and incidence of mechanical ventilation. Results Of 100 patients randomized, 49 received tocilizumab 4 mg/kg and 48 received 8 mg/kg. In pharmacokinetic and sIL-6R assessments, dose-dependent differences were seen in patients who received 1 or 2 doses of 4 or 8 mg/kg. Serum concentrations of IL-6, ferritin, and CRP and safety outcomes were comparable between groups. Through day 60, serious adverse events were reported in 30.6% and 25.0% of patients in the 4- and 8-mg/kg group, respectively. Eight patients (16.3%) in the 4-mg/kg group and 6 (12.5%) in the 8-mg/kg group died. Exploratory time-to-event outcomes favored 8-mg/kg within the first 2 weeks. Conclusions In patients with moderate-to-severe COVID-19 pneumonia who received tocilizumab 4 or 8 mg/kg, pharmacokinetic and sIL-6R assessments showed expected dose-dependent effects; pharmacodynamic assessments and safety were comparable, with no new safety signals. Further study is required before a lower dose of tocilizumab can be recommended in patients with COVID pneumonia.

scholarly journals Safety and Pharmacokinetics of CD101 IV, a Novel Echinocandin, in Healthy Adults

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Taylor Sandison ◽  
Voon Ong ◽  
Jonathan Lee ◽  
Dirk Thye
Keyword(s):  
Adverse Events ◽  
Vital Signs ◽  
High Plasma ◽  
Primary Objective ◽  
Healthy Adults ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Content Type

ABSTRACT CD101 IV is a novel echinocandin with distinctive pharmacokinetic properties that is being developed as a once-weekly treatment for candidemia and invasive candidiasis. CD101 has potent in vitro activity and in vivo efficacy against a broad range of Candida and Aspergillus species. The primary objective of two randomized, double-blind, placebo-controlled, dose-escalation studies in healthy adults was to determine the safety and tolerability of CD101 IV. Sequential cohorts of 8 subjects (n = 6, active; n = 2, placebo) were administered single (50, 100, 200, 400 mg) or multiple once-weekly (100 mg given once weekly for two weeks [×2], 200 mg ×2, 400 mg ×3) doses of CD101 IV infused over 1 h. There were no deaths, serious adverse events (SAEs), severe adverse events (AEs), or withdrawals from the study due to an AE. The majority of AEs were mild, and all completely resolved. There was a higher incidence of total AEs and mild transient infusion reactions in the 400-mg ×3 dose group. There were no clinically meaningful trends in postbaseline laboratory abnormalities and no safety issues related to electrocardiograms, vital signs, or physical exams. CD101 showed dose-proportional plasma exposures, minor accumulation (30% to 55%), low apparent clearance (<0.28 liter/h), long half-life (t 1/2) (>80 h), and minimal urine excretion. CD101 IV was safe and well tolerated at single and multiple doses of up to 400 mg given once weekly for 3 weeks and exhibited a long t 1/2, minimal accumulation over several weeks, negligible renal excretion, and high plasma exposures enabling once-weekly dosing.

scholarly journals Tolerability of Capsaicinoids fromCapsicumExtract in a Beadlet Form: A Pilot Study

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Jayant Deshpande ◽  
Shankaranarayanan Jeyakodi ◽  
Vijaya Juturu
Keyword(s):  
Adverse Events ◽  
Skin Color ◽  
Complete Blood Count ◽  
Clinical Chemistry ◽  
Vital Signs ◽  
Dose Finding ◽  
Hair Color ◽  
Open Label ◽  
Serious Adverse Events ◽  
Function Tests

A single center, open-label, dose-finding adaptive study was conducted in twelve healthy overweight female subjects. The study was to evaluate the safety and tolerability of the capsaicinoids (CAPs) fromCapsicumextract in a beadlet form compared to placebo in a healthy overweight population. The investigational product capsaicinoids (CAPs) fromCapsicumextract in a beadlet form (Capsimax®) a proprietary encapsulated form ofCapsicumextract in beadlet form supplemented at 2 mg, 4 mg, 6 mg, 8 mg and 10 mg of CAPs. An ascending dose protocol evaluated a total dose of 10 mg daily given in five divided doses (2 mg, 4 mg, 6 mg, 8 mg and 10 mg of CAPs). Each dose was given for a week. Safety and tolerability were assessed. Primary outcomes were tolerability assessments and reports of adverse events. Tolerability assessments were observed on skin color and any changes in skin, bowel movement, digestion, mouth or throat, hair color or changes in hair color, urination includes frequency and burning sensations, breathing, any changes in their health. Secondary outcomes were body weight, body mass index (BMI), blood pressure (SBP/DBP), vital signs, electrocardiograms, clinical chemistry parameters including liver function tests, lung function tests and kidney function tests and complete blood count (CBC). No dose effective changes were observed. The escalating dose levels of CAPs in a beadlet form product found was tolerable and safe for weight management studies. Tolerability assessments and safety blood markers showed no significant changes from baseline. No significant serious adverse events were reported throughout the duration of the study. Further longer term studies are required to explore the tolerability of the product. This trial is registered with ISRCTN: #  ISRCTN10975080.

scholarly journals Effect of Alemtuzumab Infusions on Vital Signs

2020 ◽  
Vol 22 (2) ◽  
pp. 53-59 ◽  
Author(s):  
Angel Chinea ◽  
William David Honeycutt ◽  
Tamara Miller ◽  
Donna Graves ◽  
Alan Jacobs ◽  
...  
Keyword(s):  
Vital Sign ◽  
Vital Signs ◽  
Serious Adverse Events ◽  
Point Change ◽  
Relapsing Remitting ◽  
Blood Pressures ◽  
Clinically Significant ◽  
Relapsing Remitting Multiple Sclerosis ◽  
Potentially Clinically Significant ◽  
Infusion Duration

Abstract Background: Alemtuzumab efficacy and safety were established in phase 3 randomized trials. We characterize vital signs during and after the first alemtuzumab infusion course. Methods: Patients with relapsing-remitting multiple sclerosis commercially prescribed alemtuzumab 12 mg/day on 5 consecutive days (initial course) were enrolled in this prospective, observational study. Preinfusion medications included methylprednisolone, antihistamine, and antipyretics. Primary end point: change from precourse baseline in vital signs during and 2 hours after each alemtuzumab infusion. Secondary end points: infusion duration and serious adverse events (AEs) starting within 24 hours and within 7 days after infusion (AEs collected up to 15 days after treatment). Potentially clinically significant vital sign abnormalities were based on predefined thresholds from literature review. Results: In the 304 patients treated, minimal increases in mean systolic (≤8 mm Hg) and diastolic (≤3 mm Hg) blood pressures from precourse baseline were observed on infusion days 3 to 5. An increase in mean heart rate (20 beats per minute) during the first infusion day normalized by day 2, and smaller increases (5 beats per minute) occurred during subsequent infusions. Serious AEs occurred in two patients (0.7%) during or within 24 hours after infusion and in three patients (1.0%) within 7 days. Mean/median infusion duration was 4 hours. Vital sign abnormalities with potential clinical significance occurred in 62.5% of patients. Conclusions: Although most patients had potentially clinically significant vital sign abnormalities, mean changes from baseline during and after infusion of the first alemtuzumab course were clinically insignificant. No new safety signals were detected.

scholarly journals Cardiovascular outcomes in adults with migraine treated with eptinezumab for migraine prevention: pooled data from four randomized, double-blind, placebo-controlled studies

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Timothy R. Smith ◽  
Egilius L. H. Spierings ◽  
Roger Cady ◽  
Joe Hirman ◽  
Anders Ettrup ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trials ◽  
Adverse Events ◽  
Vital Signs ◽  
Primary Objective ◽  
Cardiovascular Outcomes ◽  
Migraine Treatment ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Link Type

Abstract Background Patients with migraine have an increased relative risk of cardio- and cerebrovascular events, and some migraine treatments may exacerbate this risk. The primary objective of this analysis was to determine whether the rate of cardiovascular adverse events was higher for patients with migraine treated with the migraine-preventive eptinezumab, compared with patients receiving placebo. Methods Cardiovascular outcomes in patients with migraine were pooled across four clinical trials (phase 1b, phase 2, and two phase 3 trials) for use of eptinezumab as a preventive migraine treatment for up to 1 year. In all studies, treatment-emergent adverse events (TEAEs) that occurred after the first dose of study treatment (eptinezumab 100 mg, 300 mg, 1000 mg, or placebo) and vital signs were recorded through study completion. Results Cardiovascular TEAEs were rare across all four clinical trials, and rates were similar between patients receiving eptinezumab and those receiving placebo. Cardiovascular TEAEs that did occur were mild or moderate in severity; there were no serious adverse events as per FDA definition. Vital signs (systolic blood pressure, diastolic blood pressure, and heart rate) were not meaningfully different across treatment groups over the course of 56 weeks, compared to placebo. Treatment with eptinezumab did not result in significant new or changed cardiovascular medications used concomitantly compared to placebo. Conclusions In this post hoc analysis of four clinical trials for eptinezumab, doses of 100 mg, 300 mg, and 1000 mg (more than 3 times the highest approved dose) were not associated with clinically relevant changes in vital signs or significant changes in concomitant cardiovascular medication usage, and had low incidences of cardiovascular TEAEs, comparable to placebo. Trial registration NCT01772524 (Study 2), 01/21/2013; NCT02275117 (Study 5), 10/27/2014; NCT02559895 (PROMISE-1), 09/25/2017; NCT02974153 (PROMISE-2), 11/28/2016

scholarly journals Pharmacokinetics and Tolerance of the Phage Endolysin-Based Candidate Drug SAL200 after a Single Intravenous Administration among Healthy Volunteers

2017 ◽  
Vol 61 (6) ◽  
Author(s):  
Soo Youn Jun ◽  
In Jin Jang ◽  
Seonghae Yoon ◽  
Kyungho Jang ◽  
Kyung-Sang Yu ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Phase 1 ◽  
Information Service ◽  
Vital Signs ◽  
Systemic Exposure ◽  
Research Information ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Maximum Serum ◽  
Candidate Drug

ABSTRACT This study was a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dosing, and dose-escalating study of intravenous SAL200. It is a new candidate drug for the treatment of antibiotic-resistant staphylococcal infections based on a recombinant form of the phage endolysin SAL-1. The study evaluated the pharmacokinetics, pharmacodynamics, and tolerance among healthy male volunteers after the intravenous infusion of single ascending doses of SAL200 (0.1, 0.3, 1, 3, and 10 mg/kg of body weight). SAL200 was well tolerated, and no serious adverse events (AEs) were observed in this clinical study. Most AEs were mild, self-limiting, and transient. The AEs reported in more than three participants were fatigue, rigors, headache, and myalgia. No clinically significant values with respect to the findings of clinical chemistry, hematology, and coagulation analyses, urinalysis, vital signs, and physical examinations were observed, and no notable trends in our electrocardiogram (ECG) results for any tested dose were noticed. A greater-than-dose-proportional increase with regard to systemic exposure and the maximum serum concentration was observed when the SAL200 dose was increased from 0.1 mg/kg to 10 mg/kg. This investigation constitutes the first-in-human phase 1 study of an intravenously administered, phage endolysin-based drug. (This study has been registered at ClinicalTrials.gov under identifier NCT01855048 and at the Clinical Research Information Service [https://cris.nih.go.kr/cris/ ] under identifier KCT0000968.).

scholarly journals Clinical Evaluation of the Torq Zero Delay Centrifuge System for Decentralized Blood Collection and Stabilization

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1019
Author(s):  
Kyungjin Hong ◽  
Gabriella Iacovetti ◽  
Ali Rahimian ◽  
Sean Hong ◽  
Jon Epperson ◽  
...  
Keyword(s):  
Clinical Chemistry ◽  
Blood Collection ◽  
Test Results ◽  
Sample Collection ◽  
Rapid Separation ◽  
Cell Counts ◽  
Collection Device ◽  
Precision Study ◽  
Clinically Significant ◽  
Blood Specimens

Blood sample collection and rapid separation—critical preanalytical steps in clinical chemistry—can be challenging in decentralized collection settings. To address this gap, the Torq™ zero delay centrifuge system includes a lightweight, hand-portable centrifuge (ZDrive™) and a disc-shaped blood collection device (ZDisc™) enabling immediate sample centrifugation at the point of collection. Here, we report results from clinical validation studies comparing performance of the Torq System with a conventional plasma separation tube (PST). Blood specimens from 134 subjects were collected and processed across three independent sites to compare ZDisc and PST performance in the assessment of 14 analytes (K, Na, Cl, Ca, BUN, creatinine, AST, ALT, ALP, total bilirubin, albumin, total protein, cholesterol, and triglycerides). A 31-subject precision study was performed to evaluate reproducibility of plasma test results from ZDiscs, and plasma quality was assessed by measuring hemolysis and blood cells from 10 subject specimens. The ZDisc successfully collected and processed samples from 134 subjects. ZDisc results agreed with reference PSTs for all 14 analytes with mean % biases well below clinically significant levels. Results were reproducible across different operators and ZDisc production lots, and plasma blood cell counts and hemolysis levels fell well below clinical acceptance thresholds. ZDiscs produce plasma samples equivalent to reference PSTs. Results support the suitability of the Torq System for remotely collecting and processing blood samples in decentralized settings.

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