Laboratory Medicine and Quality Assurance

Table. 1.

Status of the HBsAg qualitative and neutralization assays in 17 laboratories performing neutralization testing

Variable Total (N=17) Roche reagent (N=14) Abbott reagent (N=3)
Institution type
Tertiary-care hospital 7 5 2
Secondary-care hospital 7 6 1
Health screening center 3 3 0
Instrument
Roche COBAS e801 13 12 1*
Roche COBAS e602 1 1
Roche COBAS e601 1 1
Abbott Alinity i 4 2* 2
Abbott Architect i2000 1 1
Qualitative test reporting form
Positive/negative and COI or S/Co value 16 13 3
Positive/negative 1 1 0
Annual qualitative testing volume (2022)
>150k 1 1 0
100k–150k 2 2 0
80k–100k 2 1 1
60k–80k 1 0 1
40k–60k 2 2 0
20k–40k 5 5 0
10k–20k 4 3 1
Criteria for neutralization test (COI or S/Co)
≥1.0 1 1 0
1.0–50.0 2 1 1
1.0–30.0 1 1 0
1.0–20.0 1 1 0
1.0–10.0 3 1 2
1.0–7.0 1 1 0
0.9–10.0 3 3 0
0.9–7.0 2 2 0
0.9–5.0 1 1 0
Discrepancy with different vendor reagent 2 2 0

The instruments were from the following companies: Roche Diagnostics (Mannheim, Germany) and Abbott Ireland (Sligo, Ireland).

Abbreviations: COI, cutoff index; S/Co, signal to cutoff; HBsAg, hepatitis B surface antigen.

*Some laboratories performed HBsAg qualitative assays using both Roche and Abbot reagents.

Lab Med Qual Assur 2024;46:103~108 https://doi.org/10.15263/jlmqa.2024.46.2.103
© Lab Med Qual Assur