scholarly journals Performance of the Boditech iCHROMA Covid-19 IgG antibody assay with the external quality control for UK NIBSC (National Institute of Biological Standards and Control)

2020 ◽  
Vol 2 (8) ◽  
pp. 01-04
Author(s):  
J Bolodeoku Bolodeoku
Keyword(s):  
Quality Control ◽  
Quality Control Material ◽  
External Quality Control ◽  
Antibody Assay ◽  
Igg Antibody ◽  
Control Material ◽  
External Quality ◽  
The Uk ◽  
And Control ◽  
Control Samples

Background: There is a need for laboratories to participate in EQA schemes to achieve a harmonization of test results and to improve serological testing and research on COVID-19 and SARS-CoV-2. The Boditech iCHROMA point of care immunoassay analyser has a Covid-19 antibody assay for the qualitative determination of IgG antibodies in human whole blood/serum/plasma. The National Institute for Biological Standards and Control (NIBSC) in the United Kingdom has a portfolio of reference and research reagents, including reagents for EQA that are available to laboratories to help them set up and develop accurate diagnostic tests for SARS-CoV-2 assays. Objectives: To determine the performance of the Boditech iCHROMA Covid-19 IgG antibody assay using the external quality control material provided by the UK NIBSC (National Institute for Biological Standards and Control). Results: The Boditech iCHROMA Covid-19 IgG assay using the cut off index >1.1, reported the results of the 33 positive control samples as positive with index range from 19.50 – 29.00, with a mean of 23.75 and standard deviation of SD of 2.53. It also reported the results of the 33 negative control samples as negative with an index range of 0.00 for all samples. Conclusion: The performance of the Boditech iCHROMA Covid-19 IgG antibody assay using external quality control material from the UK NIBSC was very good, confirming the precision of the Boditech iCHROMA Covid 19 IgG antibody method.

Alkaline Phosphatase Activity in Lyophilised Quality Control Serum

1979 ◽  
Vol 16 (1-6) ◽  
pp. 271-274 ◽  
Author(s):  
D. G. Bullock ◽  
F. M. McSweeney ◽  
H. Saidi ◽  
T. P. Whitehead
Keyword(s):  
Quality Control ◽  
Alkaline Phosphatase ◽  
Phosphatase Activity ◽  
Alkaline Phosphatase Activity ◽  
Storage Temperature ◽  
Quality Control Material ◽  
External Quality Control ◽  
Control Material ◽  
External Quality ◽  
Control Serum

The rise in alkaline phosphatase activity has been studied after reconstitution of 16 commercial preparations of lyophilised quality control material. The effects of storage temperature and analytical method on the rise in activity have also been studied, with a view to producing a reconstitution protocol suitable for recommendation to participants in external quality control surveys. Great differences were found in the magnitude of this rise in activity; these differences can be reduced to negligible levels if the material is mixed for 30 minutes at ambient temperature after reconstitution and then stored for not more than 4 hours at 4°C before assay.

Development of the optimal procedure for increasing HbA1c concentration in control materials for external quality assessment

MedPharmRes ◽  
2021 ◽  
Vol 5 (3) ◽  
pp. 11-15
Author(s):  
Huy Quang Vu ◽  
Tuan Manh Ha ◽  
Triet Hy Van ◽  
Huynh Tien Nguyen ◽  
Phuc Thi Diem Huynh ◽  
...  
Keyword(s):  
Quality Control ◽  
Medical Laboratory ◽  
Medical Decision ◽  
Donor Blood ◽  
External Quality Control ◽  
External Quality ◽  
Optimal Procedure ◽  
Hba1c Concentration ◽  
Control Samples

Background: The research aimed to increase certain HbA1c concentrations at medical decision levels for external quality control samples from healthy donor blood. Methods: The in vitro study was performed from October 2019 to January 2021 at Quality Control Center for Medical Laboratory at University of Medicine and Pharmacy at Ho Chi Minh City. The study observed on the conditions including the optimal buffer solutions (BAGPM, BPS, Ringer, Saline), temperature (2ºC - 8ºC, 22ºC - 24ºC, 37ºC), and glucose concentration (100 mM, 305 mM, 500 mM) affecting the HbA1c concentration in vitro to make the external quality control samples fell in normal, prediabetes, and diabetes range. At every condition, the HbA1c concentration was measured by Tina Quant method to look for the optimal procedure to increase HbA1c concentration required of the external quality control protocol. Results: The highest HbA1c concentration (11.57±0.2%) was found in BAGPM solution with 100 mM glucose after 15 days with the baseline HbA1c 5.43±0.13%; the HbA1c level increase dramatically at 37ºC in BAGPM 500 mM glucose solution in fifteen days (40.03±1.05%). Conclusions: The appropriate conditions were identified to prepare HbA1c standards for prediabetic and diabetic levels. The standards for HbA1c concentrations were recommended to prepare by incubating RBCs from non-diabetic donor blood in BAGPM solution containing glucose at 37ºC for 24 hours. Glucose concentrations should be 100 mM and 500 mM, respectively, for prediabetic level (HbA1c ~ 6.0 ± 0.12%) and diabetic level (HbA1c ~ 9.6 ± 0.17%).

Use of plasmid-derived external quality control samples in pharmacogenetic testing

2008 ◽  
Vol 9 (9) ◽  
pp. 1261-1266 ◽  
Author(s):  
Tahar van der Straaten ◽  
Jesse Swen ◽  
Renee Baak-Pablo ◽  
Henk-Jan Guchelaar
Keyword(s):  
Quality Control ◽  
External Quality Control ◽  
External Quality ◽  
Pharmacogenetic Testing ◽  
Control Samples
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