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Internal quality control for HIV testing of blood donors - Dried tube specimen as a cost-effective alternative
Ashish Dhoot1, Joy J Mammen1, Nitty S Mathews1
1Department of Transfusion Medicine and Immunohaematology, Christian Medical College, Vellore, Tamil Nadu, India.
Insights
Dried tube specimen (DTS) made from HIV-positive plasma offers a stable, low-cost internal quality control (IQC) material for blood banks. This method ensures reliable serological testing for transfusion-transmissible infections, even in resource-limited settings.
Area of Science:
- Blood banking and transfusion medicine
- Virology and infectious diseases
- Quality control and assurance
Background:
- Mandatory serological testing is crucial for blood safety.
- Internal quality control (IQC) practices in Indian blood banks are inconsistent.
- Barriers to IQC include cost, material access, and storage requirements.
Purpose of the Study:
- To validate dried tube specimen (DTS) from HIV-positive plasma as a cost-effective and stable IQC material.
- To address the need for reliable IQC in resource-limited blood banks.
- To improve the consistency of serological testing for transfusion-transmissible infections.
Main Methods:
- Pooled HIV-positive and seronegative fresh-frozen plasma (FFP).
- Prepared 20 µL aliquots of plasma into micro-centrifuge tubes and air-dried.
- Stored DTS at 2-8°C and tested on multiple platforms over 1 year for stability and consistency.
Main Results:
- 100% consistent results across all testing platforms for 139 positive and 139 negative DTS over 1 year.
- Mild deterioration in reaction strength observed, but did not impact result interpretation.
- DTS demonstrated stability when stored at 2-8°C for the entire study duration.
Conclusions:
- Dried tube specimen (DTS) maintains plasma stability at 2-8°C for up to 1 year.
- DTS is a viable option for producing cost-effective, in-house IQC materials.
- This approach can enhance blood safety in resource-restricted countries.
Background:
An important aspect of ensuring blood safety is the performance of mandatory serological testing for transfusion transmissible infections. The practice of internal quality control (IQC) in blood banks in India is nonuniform, especially the use of third-party materials. Cited reasons are cost, lack of access to control materials, and need for deep-freezers for storage, if prepared in-house.
Objective:
Validation of dried tube specimen (DTS) from HIV-positive plasma as a low-cost, stable material for use as IQC material in blood banks.
Methods:
Fresh-frozen plasma (FFP) prepared from four HIV-positive blood-donors were pooled. Equal numbers of seronegative FFPs were pooled. Twenty microlitre aliquots of plasma were made in micro-centrifuge tubes and air-dried overnight at room-temperature. These were stored in 2-8°C refrigerators and tested once weekly for 6 months on multiple platforms with different detection principles: Rapid tests, second-generation enzyme-linked immunosorbent assay (ELISA), fourth-generation ELISA, and fourth-generation Chemiluminescence immunoassay. The protocol was sustained over the next 6 months with decreased testing frequency to study the extended stability of DTS.
Results:
A total of 139 positive-DTS and 139 negative-DTS were tested with 100% samples showing consistent results on all platforms over 1 year. There was mild deterioration in reaction strengths, which did not interfere in result interpretations.
Conclusion:
Plasma in form of DTS maintained stability when stored at 2-8°C for 1 year. This provides evidence that DTS can be a modality for the production of cost-effective, stable, in-house control material for resource-restricted countries.
