Healthy Volunteers Bioanalysis, Liquid Chromatography-Mass Spectrometry, Method validation
Conditions
Interventions
healthy Thai adult volunteers any blood group, aged 18 to 60 years.
Basic Science
healthy volunteers
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to any study-related procedures 2. Healthy, literate Thai adults (male or female) aged 18-60 years 3. For all screening visits, participants must meet the following criteria before blood collection -Body weight greater than or equal to 50 kg -Blood pressure:100-160 mmHg (systolic) and 60- 100mmHg (diastolic) -Pulse: 60-100 beats per min -Temperature: body temperature less than or equal to 37.5 degrees Celsius - Haemoglobin: Hb greater than or equal to 12 .5 g/dL (female), Hb greater than or equal to 13 g/dL (male), measured using a portable hemoglobinometer via a finger-prick (no additional blood draw) 4. Have had a good nights sleep, resting for at least 5 hours 5. Willing to comply with study procedures, including blood collection via venipuncture
Exclusion criteria
Exclusion criteria: 1.Presence of any medical condition listed below -Acute infection -Febrile illness -History of abnormal bleeding or known bleeding disorders -Anaemia low haemoglobin level at screening -History of syncope or significant adverse reactions related to blood draws 2.Currently pregnant (as confirmed by urine pregnancy test) or breastfeeding women 3.History of childbirth or miscarriage within the past 6 months 4.History of major surgery (procedures performed under general anesthesia) within the past 6 months. 5.Individuals with a history of organ transplantation or hematopoietic stem cell transplantation 6.Participation in another research study or blood donation activity within the preceding three months, where the cumulative blood volume collected would exceed acceptable limits for healthy adults. The cumulative blood volume exceeding safety limits, defined as more than 500 mL within any 8-week period or 1,500 mL within any 12-month period, including blood donated for this study and any other research or clinical purpose. 7.Consumption of alcoholic beverages within 24 hours prior to blood collection 8.History of use or current use of any medications, vitamins, herbal products, or dietary supplements (oral or injectable) within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Linearity of calibration curve: Back calculated value shall be within 15 percent deviation from its nominal value except 20 percent for LLOQ. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry,Linearity of calibration curve:At least 75 percent of calibration standards and a minimum of six non-zero calibrator levels should meet the criteria in each validation run. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Accuracy and Precision:Accuracy within 15 percent deviation from its nominal value at each QC level. For LLOQ, accuracy should be within 20 percent deviation from its nominal value. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Accuracy and Precision:Standard deviation of each QC level within 15 percent. For LLOQ, standard deviation within 20 percent. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Other validation runs:At least 75 percent of non-zero calibration standards, a minimum of 8 out of 12 levels, must meet the acceptance criteria for accuracy. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Other validation runs:At least 50 percent of replicate calibration standards at each concentration level must meet the acceptance criteria. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Other validation runs:Any individual calibration standard that does not meet the acceptance criteria shall be excluded from the calibration curve. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Limit of Quantification:Mean coefficient of variation of LLOQ shall less than 20 percent and for ULOQ shall less than 15 percent. After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry ,Limit of Quantification:Mean accuracy of LLOQ shall be within 20 percent and for ULOQ shall be within15 percent of their nomina | — |
Secondary
| Measure | Time frame |
|---|---|
| Greater than 90 percent of QC in routine sample analysis are within acceptance criteria After blood collection upon enrollment Liquid Chromatography - Mass Spectrometry | — |
Countries
Thailand
Contacts
Public ContactJoel Tarning
Mahidol Oxford Tropical Medicine Research Unit
Outcome results
None listed