Abstract
Introduction
The limited availability of Centres for Disease Control Dried Blood Spot (DBS) external quality assurance (EQA) material for non-US participants and quarantine regulations, prompted the development of an Asia-Pacific DBS-EQA program. The RCPAQAP in conjunction with the Australasian Association of Clinical Biochemists (AACB) Inborn Errors Advisory Committee designed a program to fulfil local needs in the Asia-Pacific region.
Methods
The material provided was a dried blood spot consisting of a 75uL volume of whole blood on Whatman filter paper. Participants were provided with two dried blood spots per sample for analysis. The whole blood sample was spiked to achieve 6 linearly related analytes to accommodate a program of 6 surveys a year with two samples per survey.
The analytes included in the 2019 program were thyroid stimulating hormone (TSH), immunoreactive trypsinogen (IRT), tyrosine (tyr), phenylalanine (phe) and 17 hydroxy progesterone (17OHP).
The analytical performance specifications (APS) were initially set at +/-10% and the central values were derived from the all result medians and compared with the expected values from the spiking protocol.
Results
A total of 5 Australian laboratories enrolled in the program in February 2019. 4 laboratories returned results for the low (Level 1) and High (Level 6) samples, respective medians were as follows: TSH (1.0-350mIU/L) and IRT (8-220ug/L). 2 laboratories returned results for 17-OHP (5.0-150nmol/L). 5 laboratories returned results for Phenylalanine (20-2020ug/L) and tyrosine (35-1600ug/L). The initial results showed linearity for TSH, IRT, Phe and Tyrosine with greater than 80% of laboratories returning results within the APS for those analytes. This confirms the validity of the performance limits.
Conclusion
Although only a small number of laboratories participated in the 2019 program, the results indicate that most users perform within the analytical performance specifications for their method and a linear material was achieved. We have successfully established a DBS-EQA program for the Asia-Pacific region. Future developments include analyte expansion and clinical case interpretation.
The limited availability of Centres for Disease Control Dried Blood Spot (DBS) external quality assurance (EQA) material for non-US participants and quarantine regulations, prompted the development of an Asia-Pacific DBS-EQA program. The RCPAQAP in conjunction with the Australasian Association of Clinical Biochemists (AACB) Inborn Errors Advisory Committee designed a program to fulfil local needs in the Asia-Pacific region.
Methods
The material provided was a dried blood spot consisting of a 75uL volume of whole blood on Whatman filter paper. Participants were provided with two dried blood spots per sample for analysis. The whole blood sample was spiked to achieve 6 linearly related analytes to accommodate a program of 6 surveys a year with two samples per survey.
The analytes included in the 2019 program were thyroid stimulating hormone (TSH), immunoreactive trypsinogen (IRT), tyrosine (tyr), phenylalanine (phe) and 17 hydroxy progesterone (17OHP).
The analytical performance specifications (APS) were initially set at +/-10% and the central values were derived from the all result medians and compared with the expected values from the spiking protocol.
Results
A total of 5 Australian laboratories enrolled in the program in February 2019. 4 laboratories returned results for the low (Level 1) and High (Level 6) samples, respective medians were as follows: TSH (1.0-350mIU/L) and IRT (8-220ug/L). 2 laboratories returned results for 17-OHP (5.0-150nmol/L). 5 laboratories returned results for Phenylalanine (20-2020ug/L) and tyrosine (35-1600ug/L). The initial results showed linearity for TSH, IRT, Phe and Tyrosine with greater than 80% of laboratories returning results within the APS for those analytes. This confirms the validity of the performance limits.
Conclusion
Although only a small number of laboratories participated in the 2019 program, the results indicate that most users perform within the analytical performance specifications for their method and a linear material was achieved. We have successfully established a DBS-EQA program for the Asia-Pacific region. Future developments include analyte expansion and clinical case interpretation.
| Original language | English |
|---|---|
| Publication status | Published - 2019 |
| Event | Australasian Association of Clinical Biochemists 57th Annual Scientific Conference: Clinical Biochemistry - Optimising Value in Healthcare - Adelaide Convention Centre, Adelaide, Australia Duration: 15 Oct 2019 → 17 Oct 2019 Conference number: 57th https://www.aacb.asn.au/events/event/aacb-57th-annual-scientific-conference |
Conference
| Conference | Australasian Association of Clinical Biochemists 57th Annual Scientific Conference |
|---|---|
| Abbreviated title | AACB 57th ASM |
| Country/Territory | Australia |
| City | Adelaide |
| Period | 15/10/19 → 17/10/19 |
| Internet address |
Keywords
- Quality Assurance
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