Performance evaluation of NeuMoDx 96 system for hepatitis B and C viral load

doi:10.5501/wjv.v12.i4.233

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Sep 25, 2023 (publication date) through Dec 27, 2024

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World Journal of Virology

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2220-3249

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Virol. Sep 25, 2023; 12(4): 233-241
Published online Sep 25, 2023. doi: 10.5501/wjv.v12.i4.233

Table 1 Comparison of characteristics between assay 1 and assay 2

Parameter	HBV		HCV
Parameter	Assay 1	Assay 2	Assay 1	Assay 2
Sample volume	550 µL plasma	650 µL plasma	550 µL plasma	650 µL plasma
Turnaround time	Approximately 1.00 h	Approximately 5.00 h	Approximately 1.25 h	Approximately 5.45 h
LOD in IU/mL	8.0	20	8.0	≥ 15
LLOQ as log₁₀ IU/mL	0.9	1.3	0.9	1.5
Linear range quantification as log₁₀ IU/mL	1-9	1.3-8.2	1-9	1.5

HBV: Hepatitis B virus; HCV: Hepatitis C virus; IU: International unit; LLOQ: Lower limit of quantitation; LOD: Limit of detection.

Table 2 Baseline demographic and clinical characteristics of the study population

Characteristic	HBV patient group	HCV patient group
Patients, n	99	87
Sex as M/F ratio	3.34:1.00	1.71:1.00
Age in yr, mean ± SD	44.0 ± 14.6	46.0 ± 14.9
Total bilirubin in mg/dL, median (IQR)	0.83 (0.59-0.83)	0.95 (0.58-2.15)
Direct bilirubin in mg/dL, median (IQR)	0.18 (0.10-0.47)	0.25 (0.10-0.62)
ALT values in IU/mL, median (IQR)	32.5 (23.2-60.1)	33 (17.0-59.7)
AST values in IU/mL, median (IQR)	36 (28.00-62.75)	46 (27.0-99.2)
NeuMoDx viral load as log₁₀ IU/mL, median (IQR)	2.9 (2.0-4.3)	4.9 (4.2-5.4)
COBAS viral load as log₁₀ IU/mL, median (IQR)	3.7 (2.28-4.56)	5.1 (4.07-5.80)

ALT: Alanine transaminase, AST: Aspartate aminotransferase; F: Female; HBV: Hepatitis B virus; HCV: Hepatitis C virus; IQR: Interquartile range; IU: International unit; M: Male; SD: Standard deviation.

Table 3 Comparison of hepatitis B virus viral load results between assay 1 and assay 2

Range of viral load as log₁₀ IU/mL	HBV
Range of viral load as log₁₀ IU/mL	Assay 1, n = 49	Assay 2, n = 49
10¹-10³	n = 25 (51.0%)	n = 19 (38.7%)
10³-10⁶	n = 18 (36.7%)	n = 25 (51.0%)
> 10⁶	n = 6 (12.2%)	n = 5 (10.2%)

HBV: Hepatitis B virus.

Table 4 Comparison of hepatitis C virus viral load results between assay 1 and assay 2

Range of viral load (log₁₀ IU/mL)	HCV
Range of viral load (log₁₀ IU/mL)	Assay 1 (n = 39)	Assay 2 (n = 39)
10¹-10³	n = 4 (10.2%)	n = 2 (5.1%)
10³-10⁶	n = 32 (82.0%)	n = 28 (71.7%)
> 10⁶	n = 3 (7.69%)	n = 9 (23.07%)

HCV: Hepatitis C virus.

Citation: Chooramani G, Samal J, Rani N, Singh G, Agarwal R, Bajpai M, Kumar M, Prasad M, Gupta E. Performance evaluation of NeuMoDx 96 system for hepatitis B and C viral load. World J Virol 2023; 12(4): 233-241
URL: https://www.wjgnet.com/2220-3249/full/v12/i4/233.htm
DOI: https://dx.doi.org/10.5501/wjv.v12.i4.233