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Pediatric Quality & Safety 2023Sugammadex is a medication that may have cost considerations with the potential for waste of unused product in pediatric patients due to the vial size and its single-use...
UNLABELLED
Sugammadex is a medication that may have cost considerations with the potential for waste of unused product in pediatric patients due to the vial size and its single-use limitation. Therefore, exploring the potential of vial-splitting for perioperative use may be beneficial.
METHODS
The study was a retrospective, quality improvement study using the electronic medical record to identify every sugammadex administration over the last five years in a tertiary care pediatric institution. We divided patients into groups depending on the dose of sugammadex administered. The cost of sugammadex was calculated under three scenarios: (1) only 200-mg vials available; (2) 100-mg aliquots available; and (3) 50-mg aliquots. We then calculated the total money spent per patient in the 3 scenarios.
RESULTS
31,063 patients received sugammadex over the study period, of whom 23.6% received 151-200 mg. The greatest percentage of patients received ≤50 mg (32.9%). The average cost per patient was $113.58, $81.61, and $68.83 if 200 mg, 100 mg, and 50 mg doses were available, respectively. Over the last 5 years, $1,390,110.13 could have been saved by having 50 and 100 mg aliquots available.
CONCLUSIONS
Pediatric patients generally receive lower doses of sugammadex due to weight-based dosing, leading to increased waste and cost when using only 200-mg vials. Vial-splitting into smaller aliquots can significantly cut costs for healthcare centers and patients while decreasing waste.
PubMed: 37051405
DOI: 10.1097/pq9.0000000000000646 -
Microbiome May 2018Convenient, reproducible, and rapid preservation of unique biological specimens is pivotal to their use in microbiome analyses. As an increasing number of human studies...
BACKGROUND
Convenient, reproducible, and rapid preservation of unique biological specimens is pivotal to their use in microbiome analyses. As an increasing number of human studies incorporate the gut microbiome in their design, there is a high demand for streamlined sample collection and storage methods that are amenable to different settings and experimental needs. While several commercial kits address collection/shipping needs for sequence-based studies, these methods do not preserve samples properly for studies that require viable microbes.
RESULTS
We describe the Fecal Aliquot Straw Technique (FAST) of fecal sample processing for storage and subsampling. This method uses a straw to collect fecal material from samples recently voided or preserved at low temperature but not frozen (i.e., 4 °C). Different straw aliquots collected from the same sample yielded highly reproducible communities as disclosed by 16S rRNA gene sequencing; operational taxonomic units that were lost, or gained, between the two aliquots represented very low-abundance taxa (i.e., < 0.3% of the community). FAST-processed samples inoculated into germ-free animals resulted in gut communities that retained on average ~ 80% of the donor's bacterial community. Assessment of choline metabolism and trimethylamine-N-oxide accumulation in transplanted mice suggests large interpersonal variation.
CONCLUSIONS
Overall, FAST allows for repetitive subsampling without thawing of the specimens and requires minimal supplies and storage space, making it convenient to utilize both in the lab and in the field. FAST has the potential to advance microbiome research through easy, reproducible sample processing.
Topics: Animals; Bacteria; Base Sequence; Feces; Gastrointestinal Microbiome; Humans; Methylamines; Mice; RNA, Ribosomal, 16S; Sequence Analysis, DNA; Specimen Handling
PubMed: 29776435
DOI: 10.1186/s40168-018-0458-8 -
International Journal of Pharmaceutical... 2015The purpose of this research was to collect, analyze, and compare stability data for levothyroxine (T4) powder in the anhydrous and pentahydrate form when prepared as an... (Review)
Review
The purpose of this research was to collect, analyze, and compare stability data for levothyroxine (T4) powder in the anhydrous and pentahydrate form when prepared as an aliquot and in capsules. Two different compounding pharmacies, Central Iowa Compounding and Gateway Medical Pharmacy, used different forms of T4 and aliquot formulations, which were studied to determine the beyond-use date at ±5% or ±10% of labeled strength. T4 was extracted from aliquot and capsule formulations and assessed using reverse-phase high- performance liquid chromatography validated to differentiate between the degraded and original forms of T4. The results indicate that T4 1:100 aliquot formulation prepared with silica gel or Avicel as filler are stable for 120 days at ±10% labeled potency, but at ±5% labeled potency, the silica gel and Avicel aliquot formulations are stable for 45 and 30 days, respectively. The silica gel capsules prepared from fresh aliquot were stable for 120 days at ±10% labeled potency and 90 days at ±5% labeled potency, while the Avicel capsules prepared from fresh aliquot were stable for 180 days at both ±10% and ±5% labeled potency. Avicel capsules prepared from old aliquot (120 days) and fresh aliquot (1 day) were also compared for stability. The old aliquot Avicel capsules were stable for 14 days at ±5% labeled potency and 150 days at ±10% labeled potency, while new aliquot Avicel capsules were stable for 180 days at both ±10% and ±5% labeled potency. Based on our data, there can be significant variation in the beyond-use dates assigned to T4 capsules based on the diluents used for aliquots, the final capsule formulations, and the potency standards applied. These results also indicate that pharmacists must exercise caution when using older aliquots and may have to assign shorter beyond-use dates.
Topics: Capsules; Chromatography, High Pressure Liquid; Chromatography, Reverse-Phase; Drug Compounding; Drug Stability; Thyroxine
PubMed: 26775448
DOI: No ID Found -
Cancer Epidemiology, Biomarkers &... May 1997Because archived blood specimens are an important but limited resource for conducting epidemiological studies using biomarkers, it is important to develop analytical...
Because archived blood specimens are an important but limited resource for conducting epidemiological studies using biomarkers, it is important to develop analytical techniques that minimize the amount of sample needed. We modified an established 1.0-ml blood plasma organochlorine assay to use smaller volumes. We assessed its utility by comparing the accuracy and precision of measurements obtained with different-sized aliquots of spiked plasma from three pools of known concentration of 1,1-dichloro-2,2-bis(p-chlorophenyl)ethylene (DDE) and polychlorinated biphenyls (PCBs; low, medium, and high). There was a modest sacrifice in accuracy using 0.5 as opposed to 1.0 ml. However, the within-batch coefficients of variation, a measure of laboratory error, were consistently low when 0.5-ml aliquots were used. For both DDE and PCB concentrations, this error was less than 5% for the medium and high pools [5-20 parts per billion (ng/ml)] and less than 9% for the low pool (< 1 part per billion). After determining that aliquots of 0.5 ml were sufficient, we performed a blinded quality control analysis of stored plasma. In this study, the within-subject variation was low for DDE and PCBs and substantially lower than the between-subject variation, suggesting that the assay would rank subjects with reasonable precision. Our results suggest that use of 0.5-ml as opposed to 1.0-ml aliquots should not compromise the power of a nested case-control study to detect differences between subjects and would thus save plasma for future research. For populations with very low levels of organochlorines, however, the larger volumes should still be used.
Topics: Blood Specimen Collection; Blood Volume; Carcinogens; Dichlorodiphenyl Dichloroethylene; Environmental Monitoring; Humans; Polychlorinated Biphenyls; Quality Control; Reference Values; Reproducibility of Results
PubMed: 9149893
DOI: No ID Found -
Journal of Clinical Microbiology Apr 2012We compared bacillary loads after splitting sputum specimens by chemical (N-acetyl-l-cysteine [NALC]) and mechanical homogenization by vortexing with sterile glass... (Clinical Trial)
Clinical Trial Comparative Study
We compared bacillary loads after splitting sputum specimens by chemical (N-acetyl-l-cysteine [NALC]) and mechanical homogenization by vortexing with sterile glass beads. NALC and vortexing with glass beads were equally effective at homogenizing sputum specimens, resulting in an equal distribution of tubercle bacilli in the aliquots.
Topics: Adolescent; Adult; Aged; Bacterial Load; Humans; Middle Aged; Mycobacterium tuberculosis; Specimen Handling; Sputum; Tuberculosis, Pulmonary; Young Adult
PubMed: 22278836
DOI: 10.1128/JCM.05835-11 -
Clinical Chemistry and Laboratory... Dec 2013Cerebrospinal fluid (CSF) amyloid β1-42 (Aβ1-42), total tau (T-tau) and phosphorylated tau181 (P-tau) are finding increasing utility as biomarkers of Alzheimer's...
BACKGROUND
Cerebrospinal fluid (CSF) amyloid β1-42 (Aβ1-42), total tau (T-tau) and phosphorylated tau181 (P-tau) are finding increasing utility as biomarkers of Alzheimer's disease (AD). The purpose of this study was to determine whether measured CSF biomarker concentrations were affected by aliquot storage volume and whether addition of detergent-containing buffer mitigates any observed effects.
METHODS
AD and control CSF was distributed into polypropylene tubes in aliquots of different volumes (50-1500 μL). Aβ1-42, T-tau and P-tau were measured with and without addition of Tween 20 (0.05%).
RESULTS
Measured concentrations of Aβ1-42 increased two-fold with aliquot storage volume. A volume increase of 10 µL caused an Aβ1-42 increase of 0.95 pg/mL [95% confidence interval (CI) 0.36-1.50, p=0.02] in controls, and 0.60 pg/mL (CI 0.23-0.98 pg/mL, p=0.003) in AD samples. Following addition of Tween 20, the positive relationship between Aβ1-42 and aliquot volume disappeared. T-tau and P-tau were not significantly affected.
CONCLUSIONS
CSF aliquot storage volume has a significant impact on the measured concentration of Aβ1-42. The introduction of a buffer detergent at the initial aliquoting stage may be an effective solution to this problem.
Topics: Alzheimer Disease; Amyloid beta-Peptides; Artifacts; Biomarkers; Buffers; Humans; Peptide Fragments; Specimen Handling; tau Proteins
PubMed: 23940064
DOI: 10.1515/cclm-2013-0293 -
Clinical Chemistry Nov 2007Nucleic acid amplification technologies significantly improved the limit of detection (LOD) for diagnostic assays. The ability of these assays to amplify fewer than 10...
BACKGROUND
Nucleic acid amplification technologies significantly improved the limit of detection (LOD) for diagnostic assays. The ability of these assays to amplify fewer than 10 target copies of DNA or RNA imposes new requirements on the preparation of clinical samples. We report a statistical method to determine how large of an aliquot is necessary to reproducibly provide a detectable number of cells.
METHODS
We determined the success probability (p) based on aliquot size and sample volume. The binomial distribution, based on p and the concentration of cells in sample, was used to calculate the probability of getting no target objects in an aliquot and to determine the minimum number of objects per aliquot necessary to generate a reproducible clinical assay.
RESULTS
The described method was applied to find a minimum aliquot volume required for a set LOD, false-negative rate (FNR), and %CV. For example, to keep FNR <0.01% for 0.5%, 1% and 2% aliquots (minimum 2000, 1000, and 500 cells per sample) are required. Comparison between experimental and predicted FNR demonstrated good correlation for the small volume aliquots and/or low concentration of target. When 4 muL of 200 copies/mL of plasmid is amplified, predicted and experimental FNRs are 47.2% and 44.9%.
CONCLUSION
This probability model is a useful tool to predict the impact of aliquot volume on the LOD and reproducibility of clinical assays. Even for samples for which pathogens are homogeneously distributed, it is theoretically impossible to collect a single pathogen consistently if the concentration of pathogen is below a certain limit.
Topics: Clinical Laboratory Techniques; DNA; False Negative Reactions; Nucleic Acid Amplification Techniques; Plasmids; Polymerase Chain Reaction; Probability; Reproducibility of Results; Sensitivity and Specificity; Solutions
PubMed: 17761752
DOI: 10.1373/clinchem.2007.089854 -
Lab on a Chip Mar 2023Sandwich immunoassays such as the enzyme-linked immunosorbent assay (ELISA) have been miniaturized and performed in a lab-on-a-chip format, but the execution of the...
Sandwich immunoassays such as the enzyme-linked immunosorbent assay (ELISA) have been miniaturized and performed in a lab-on-a-chip format, but the execution of the multiple assay steps typically requires a computer or complex peripherals. Recently, an ELISA for detecting antibodies was encoded structurally in a chip thanks to the microfluidic chain reaction (Yafia , 2022, , 464-469), but the need for precise pipetting and intolerance to commonly used surfactant concentrations limit the potential for broader adoption. Here, we introduce the ELISA-on-a-chip with aliquoting functionality that simplifies chip loading and pipetting, accommodates higher surfactant concentrations, includes barrier channels that delay the contact between solutions and prevent undesired mixing, and that executed a quantitative, high-sensitivity assay for the SARS-CoV-2 nucleocapsid protein in 4×-diluted saliva. Upon loading the chip using disposable pipettes, capillary flow draws each reagent and the sample into a separate volumetric measuring reservoir for detection antibody (70 μL), enzyme conjugate (50 μL), substrate (80 μL), and sample (210 μL), and splits washing buffer into 4 different reservoirs of 40, 40, 60, and 20 μL. The excess volume is autonomously drained a structurally encoded capillaric aliquoting circuit, creating aliquots with an accuracy of >93%. Next, the user click-connects the assay module, comprising a nitrocellulose membrane with immobilized capture antibodies and a capillary pump, to the chip which triggers the step-by-step, timed flow of all aliquoted solutions to complete the assay in 1.5 h. A colored precipitate forming a line on a nitrocellulose strip serves as an assay readout, and upon digitization, yielded a binding curve with a limit of detection of 54 and 91 pg mL for buffer and diluted saliva respectively, vastly outperforming rapid tests. The ELISA chip is 3D-printed, modular, adaptable to other targets and assays, and could be used to automate ELISA in the lab; or as a diagnostic test at the point of care with the convenience and form factor of rapid tests while preserving the protocol and performance of central laboratory ELISA.
Topics: Humans; Collodion; COVID-19; SARS-CoV-2; Enzyme-Linked Immunosorbent Assay; Antibodies; Antibodies, Immobilized; Printing, Three-Dimensional; Lab-On-A-Chip Devices
PubMed: 36723136
DOI: 10.1039/d2lc00878e -
Micromachines Jul 2023The detection of nucleic acids as specific markers of infectious diseases is commonly implemented in molecular biology laboratories. The translation of these benchtop...
The detection of nucleic acids as specific markers of infectious diseases is commonly implemented in molecular biology laboratories. The translation of these benchtop assays to a lab-on-a-chip format demands huge efforts of integration and automation. The present work is motivated by a strong requirement often posed by molecular assays that combine isothermal amplification and CRISPR/Cas-based detection: after amplification, a 2-8 microliter aliquot of the reaction products must be taken for the subsequent reaction. In order to fulfill this technical problem, we have designed and prototyped a microfluidic device that is able to meter and aliquot in the required range during the stepped assay. The operation is achieved by integrating a porous material that retains the desired amount of liquid after removing the excess reaction products, an innovative solution that avoids valving and external actuation. The prototypes were calibrated and experimentally tested to demonstrate the overall performance (general fluidics, metering, aliquoting, mixing and reaction). The proposed aliquoting method is fully compatible with additional functions, such as sample concentration or reagent storage, and could be further employed in alternative applications beyond molecular diagnosis.
PubMed: 37512736
DOI: 10.3390/mi14071425 -
Journal of Clinical Microbiology Sep 2009Although venipuncture is the preferred method for obtaining blood cultures, specimens often are obtained from intravenous catheters (IVC). For IVC-drawn blood cultures,...
Although venipuncture is the preferred method for obtaining blood cultures, specimens often are obtained from intravenous catheters (IVC). For IVC-drawn blood cultures, some authorities recommend discarding the initial 5 to 10 ml of blood to reduce contamination and remove potential inhibitory substances. To determine whether this practice reduced contamination rates (CR), we assessed the results of IVC-drawn blood cultures for adults. Thirty milliliters of blood was obtained aseptically. The first 10 ml, rather than being discarded, was inoculated into an aerobic culture vial. Using a second sterile syringe, 20 ml of blood was obtained and inoculated in 10-ml aliquots to aerobic and anaerobic culture vials. Positive cultures were evaluated to assess clinical significance (true versus contaminant). Out of 653 IVC-drawn blood culture pairs, both vials were contaminated in 38 pairs (5.8%); only the "discard" vial was contaminated in 33 (5.1%); and only the "standard" vial was contaminated in 31 (4.7%). Overall CR were 10.9% for the discard vial versus 10.5% for the standard vial (P = 0.90). We conclude that discarding an initial aliquot of blood when obtaining blood cultures from IVCs does not reduce CR.
Topics: Bacteremia; Blood; Blood Specimen Collection; Catheterization; Diagnostic Errors; Humans; Phlebotomy
PubMed: 19641064
DOI: 10.1128/JCM.00292-09