<abstract xmlns="http://www.w3.org/1999/xhtml">

<p>The transmission of human immunodeficiency virus (HIV) through blood poses a slightly increased risk. As a result, patients requiring blood transfusions should be screened for HIV antibodies. This study examined the diagnostic effectiveness of the photostimulated chemiluminescence assay in detecting anti-HIV antibodies and determined the cut-off value for this method. The performance of the fully automated photostimulated chemiluminescence assay system was validated according to CNAS-GL038:2019 (2020) and CNAS-GL037:2019 (2019) guidelines. A retrospective study was conducted at the Department of Medical Laboratory, Nanjing Tongren Hospital, affiliated with Southeast University, from January 2020 to December 2022. A total of 77,386 cases were tested for anti-HIV antibodies using the photostimulated chemiluminescence assay, with 79 cases initially testing positive. The method’s performance in detecting anti-HIV antibodies was evaluated using the Receiver Operating Characteristic (ROC) curve and the average Coefficient of Variation (CV) value of 3-year in-house quality control. The precision, detection limit, coincidence rate, and critical value of the performance verification results met the requirements. Using Western blotting (WB) as the reference method, positive cases were initially screened using the light-induced chemiluminescence method to determine the cut-off index (COI) value and draw the ROC curve. The maximum area under the ROC curve using the chemiluminescence method was 0.997, with a cutoff value of &lt; 28.56, sensitivity of 98%, specificity of 100%, Jordan index of 0.98, and an average CV value of 3.55%. In conclusion, the photostimulated chemiluminescence assay has good diagnostic efficacy in detecting anti-HIV antibodies and is suitable for rapid screening before blood transfusion and surgery.</p>
</abstract>

The transmission of human immunodeficiency virus (HIV) through blood poses a slightly increased risk. As a result, patients requiring blood transfusions should be screened for HIV antibodies. This study examined the diagnostic effectiveness of the photostimulated chemiluminescence assay in detecting anti-HIV antibodies and determined the cut-off value for this method. The performance of the fully automated photostimulated chemiluminescence assay system was validated according to CNAS-GL038:2019 (2020) and CNAS-GL037:2019 (2019) guidelines. A retrospective study was conducted at the Department of Medical Laboratory, Nanjing Tongren Hospital, affiliated with Southeast University, from January 2020 to December 2022. A total of 77,386 cases were tested for anti-HIV antibodies using the photostimulated chemiluminescence assay, with 79 cases initially testing positive. The method’s performance in detecting anti-HIV antibodies was evaluated using the Receiver Operating Characteristic (ROC) curve and the average Coefficient of Variation (CV) value of 3-year in-house quality control. The precision, detection limit, coincidence rate, and critical value of the performance verification results met the requirements. Using Western blotting (WB) as the reference method, positive cases were initially screened using the light-induced chemiluminescence method to determine the cut-off index (COI) value and draw the ROC curve. The maximum area under the ROC curve using the chemiluminescence method was 0.997, with a cutoff value of < 28.56, sensitivity of 98%, specificity of 100%, Jordan index of 0.98, and an average CV value of 3.55%. In conclusion, the photostimulated chemiluminescence assay has good diagnostic efficacy in detecting anti-HIV antibodies and is suitable for rapid screening before blood transfusion and surgery.

Diagnostic Efficacy of Photostimulated Chemiluminescence Assay for Detecting Anti-HIV Antibodies: A Retrospective Study

Polish Journal of Microbiology

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

The transmission of human immunodeficiency virus (HIV) through blood poses a slightly increased risk. As a result, patients requiring blood transfusions should...

Indicator	Low S/CO	High S/CO	Negative S/CO
Mean	3.734	15.495	0.461
SD	0.063	0.268	0.014
CV	1.68%	1.73%	3.03%

Indicator	Low S/CO	High S/CO	Negative S/CO
Mean	4.018	16.284	0.474
SD	0.065	0.365	0.016
CV	1.63%	2.24%	3.38%

Year	CV%
2020	3.61%
2021	3.36%
2022	3.67%
Mean	3.55%

LICA500 in our hospital	LICA500 in Taizhou People’s Hospital		Agreement
LICA500 in our hospital	Positive	Negative	Agreement
Positive	10	0	100%
Negative	0	10	100%

COI	Photostimulated chemiluminescence assay positive	WB positive	WB negative
1.0–10.0	26	1	25
10.0–20.0	2	0	2
20.0–30.0	2	0	2
30.0–40.0	2	2	0
> 40.0	47	47	0
Total	79	50	29

Diagnostic Efficacy of Photostimulated Chemiluminescence Assay for Detecting Anti-HIV Antibodies: A Retrospective Study

Article Category: ORIGINAL PAPER

Publicado en línea: 16 dic 2023

Páginas: 461 - 466

Recibido: 30 jul 2023

Aceptado: 27 oct 2023

DOI: https://doi.org/10.33073/pjm-2023-043

Palabras clave
anti-HIV, blood transfusion, diagnostic efficiency, photostimulated chemiluminescence assay

© 2023 Jianxiang Han et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Fig. 1.

Coefficient of variation of the intra test for photostimulated chemiluminescence assay.

Coefficient of variation of the inter test for photostimulated chemiluminescence assay.

CV values for three years of in-house quality control.

Agreement of inter-test measure photostimulated chemiluminescence assay.

Distribution ranges of COI values and WB test results in photostimulated chemiluminescence assay.

Diagnostic Efficacy of Photostimulated Chemiluminescence Assay for Detecting Anti-HIV Antibodies: A Retrospective Study

Article Category: ORIGINAL PAPER

Publicado en línea: 16 dic 2023

Páginas: 461 - 466

Recibido: 30 jul 2023

Aceptado: 27 oct 2023

DOI: https://doi.org/10.33073/pjm-2023-043

Palabras claveanti-HIV, blood transfusion, diagnostic efficiency, photostimulated chemiluminescence assay

© 2023 Jianxiang Han et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Fig. 1.

Coefficient of variation of the intra test for photostimulated chemiluminescence assay.

Coefficient of variation of the inter test for photostimulated chemiluminescence assay.

CV values for three years of in-house quality control.

Agreement of inter-test measure photostimulated chemiluminescence assay.

Distribution ranges of COI values and WB test results in photostimulated chemiluminescence assay.

Palabras clave
anti-HIV, blood transfusion, diagnostic efficiency, photostimulated chemiluminescence assay