Homogeneity study of the internal quality control sera for
               immunodiagnosis of HIV/AIDS

Castejon, Márcia Jorge; Yamashiro, Rosemeire; Oliveira, Camila Cardoso de; Olivieri, José Carlos; Oliveira, Carmem Aparecida de Freitas; Ueda, Mirthes

doi:10.1590/S1676-24442014000100006

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LABORATORY MEDICINE • J. Bras. Patol. Med. Lab. 50 (1) • Feb 2014 • https://doi.org/10.1590/S1676-24442014000100006 copy

Homogeneity study of the internal quality control sera for immunodiagnosis of HIV/AIDS

Estudo de homogeneidade dos soros utilizados em controle de qualidade interno de testes imunodiagnósticos de HIV/Aids

Authorship SCIMAGO INSTITUTIONS RANKINGS

Introduction:

The present study reports the data from the first homogeneity assessment of samples composing the serum panels produced at the Immunology Center of Instituto Adolfo Lutz, São Paulo. These samples have been distributed to the public laboratories and those partaking in the Brazilian Unified Health System, and to the participants in the Internal Quality Control Program for human immunodeficiency virus (HIV) antibody (Ab) testing.

Objective:

To assess the homogeneity of serum samples in panels from different lots for HIV/acquired immunodeficiency syndrome (AIDS) immunodiagnosis by using the statistical method to ensure quality of the reference material.

Method:

Sera homogeneity was evaluated by means of enzyme-linked immunoassay/enzyme immunoassay (ELISA/EIA) for detection of HIV Ab, and the one-way analysis of variance was employed for analyzing the data. No statistically significant differences were found among the several serum vials.

Conclusion:

The sera dispensed in the vials were homogeneous in the respective lots.

reference material; HIV; quality control; immunoenzyme techniques

HIV-negative sera									HIV-positive sera
	065				063					IQC 061				IQC 067
Vials	1	2	3	Mean	1	2	3	Mean	Vials	1	2	3	Mean	1	2	3	Mean
Overall mean				0.41				0.37					2.27				2.36
Relative standard deviation (RSD)				9.63%				4.32%					3.15%				2.23%
1	0.36	0.55	0.46	0.46	0.38	0.43	0.38	0.39	1	2.51	2.38	2.26	2.38	2.41	2.39	2.34	2.38
2	0.39	0.38	0.48	0.42	0.32	0.38	0.36	0.35	2	2.6	2.28	2.07	2.32	2.33	2.25	2.28	2.28
3	0.39	0.49	0.5	0.46	0.34	0.42	0.43	0.4	3	2.55	2.41	2.07	2.35	2.26	2.44	2.22	2.3
4	0.54	0.4	0.45	0.46	0.33	0.35	0.4	0.36	4	2.48	2.26	1.97	2.24	2.42	2.5	2.27	2.4
5	0.39	0.42	0.42	0.41	0.3	0.38	0.42	0.37	5	2.36	2.14	2.24	2.25	2.55	2.25	2.33	2.38
6	0.37	0.41	0.41	0.4	0.34	0.34	0.4	0.36	6	2.27	2.32	2.45	2.34	2.33	2.42	2.26	2.33
7	0.35	0.33	0.4	0.36	0.41	0.35	0.36	0.37	7	2.23	2.29	2.15	2.22	2.43	2.44	2.49	2.45
8	0.62	0.38	0.46	0.49	0.34	0.45	0.35	0.38	8	2.5	2.26	2.15	2.31	2.44	2.48	2.2	2.37
9	0.35	0.44	0.4	0.4	0.39	0.35	0.39	0.38	9	2.3	2.09	2.05	2.15	2.38	2.42	2.22	2.34
10	0.36	0.37	0.36	0.36	0.34	0.31	0.39	0.35	10	2.37	2.29	2.18	2.28	2.48	2.4	2.3	2.39
11	0.4	0.48	0.45	0.44	0.31	0.33	0.38	0.34	11	2.25	2.43	2.08	2.25	2.41	2.27	2.15	2.28
12	0.35	0.31	0.45	0.37	0.32	0.36	0.43	0.37	12	2.13	2.24	2.15	2.17	2.6	2.27	2.35	2.4
13	0.32	0.36	0.4	0.36	0.33	0.34	0.41	0.36	-	-	-	-	-	-	-	-	-
14	0.36	0.37	0.43	0.39	0.28	0.36	0.42	0.36	-	-	-	-	-	-	-	-	-
15	0.36	0.39	0.46	0.41	0.34	0.32	0.41	0.35	-	-	-	-	-	-	-	-	-
16	0.38	0.45	0.44	0.42	0.3	0.34	0.44	0.36	-

Lot number	Variation source	Degrees of freedom (df)	Quadratic mean (QM)	F_calculated	p-value	F_critical
065	Between vials	15	0.0048	1.381	0.215	1.992
065	Within vials	32	0.0034	-	-	-
063	Between vials	15	0.00075	0.326	0.988	1.992
063	Within vials	32	0.0023	-	-	-
IQC 061	Between vials	11	0.015	0.556	0.845	2.216
IQC 061	Within vials	24	0.028	-	-	-
IQC 067	Between vials	11	0.0083	0.662	0.759	2.216
IQC 067	Within vials	24	0.013	-	-	-

Lot number	Overall mean	SR	Sbb	Ubb	Ubb (%)
065	0.41	0.059	0.021	0.021	5.1
063	0.37	0.048	0	0.014	3.8
IQC 061	2.27	0.166	0	0.052	2.3
IQC 067	2.36	0.112	0	0.035	1.5

Lot number	0.65	063	IQC 061	IQC 067
Ubb (%)	5.1	3.8	2.3	1.5

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[1] MAILING ADDRESS. Márcia Jorge Castejon. Instituto Adolfo Lutz - Centro de Imunologia; Av. Dr. Arnaldo, 351, 10º andar; CEP: 01246-000; São Paulo-SP, Brazil; e-mail: mcastejon@ial.sp.gov.br.