Performance of rapid tests compared to conventional tests used for HIV diagnosis

Castejon, Márcia Jorge; Yamashiro, Rosemeire; Oliveira, Carmem Aparecida F.; Brigido, Luis Fernando M.; Generoso, Igor P.; Veras, Maria Amélia S. M.; Kerr, Ligia Regina F. S.

doi:10.5935/1676-2444.20180058

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LABORATORY MEDICINE, Original article • J. Bras. Patol. Med. Lab. 54 (6) • Nov-Dec 2018 • https://doi.org/10.5935/1676-2444.20180058 copy

Performance of rapid tests compared to conventional tests used for HIV diagnosis

Desempenho dos testes rápidos em relação aos testes convencionais utilizados no diagnóstico de HIV

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Introduction:

Early diagnosis is an important tool for strategies to fight human immunodeficiency virus (HIV) infection.

Objective:

The main objective of this study is to evaluate the comparability of the results of rapid tests (RT) used for the HIV diagnosis in relation to conventional molecular and serological tests in blood samples from a population of men who have sex with men (MSM), from 12 Brazilian capitals.

Material and methods:

591 HIV-1 reactive test samples from 4176 MSM participants were submitted to Instituto Adolfo Lutz (IAL) for evaluation by conventional laboratory tests. From these samples with at least one RT reagent, 522 samples were analyzed, and in 493 (94.4%) the HIV positivity was confirmed, with 33% HIV-1 viral load above 5,000 copies/mL and 67% by the serological tests. A total of 336 (10%) samples with a non-reactive RT result were evaluated by standard serology, four (1.2%) tested positive for HIV.

Results and conclusion:

The results showed a high percentage of samples with confirmed HIV positivity in the conventional laboratory tests, as well as some non-reactive results that were confirmed positive, indicating some limitations of the RT single-step method. Therefore, the serological tests had a fundamental role in clarifying the diagnosis.

Key words:
anti-HIV antibodies; immunoassay; viral load; serology; male homosexuality; Brazil

VL	UD	< 40 copies/ml	42-1.9 million	copies/ml	Total
TR1 (+)/TR2 (+)	212	37	> 5,000 162	< 5,000 126	537
TR1 (+)/TR2 (-)	16	0	1	1	18

Treatment and VL (RT1 and RT2 reagents)
ART	Viremia not detected	Viremia detected	Total
Yes	159	78	237
No	51	243	294
In the past	2	4	6

no. of samples (n = 392)		RT1	RT2	CLIA	IBR	WB
321	81.8%	(+)	(+)	(+)	(+)	NC
13	3.3%	(+)	(+)	(-)	(-)	NC
11	2.8%	(+)	(-)	(-)	(-)	NC
1	0.3%	(+)	(-)	(-)	NC	NC
3	0.7%	(+)	(-)	(+)	(+)	NC
5	1.3%	(+)	(+)	(+)	I	(+)
2	0.5%	(+)	(+)	(+)	I	I
1	0.3%	(+)	(+)	(-)	I	(-)
1	0.3%	(+)	(-)	(+)^* * value close to the cut-off; IM: insufficient material.	(-)	NC
1	0.3%	(+)	(-)	(+)	I	(+)
33	8.4%	(+)	(+)	IM	IM	IM
Total (+)		392	375	333	324	6

Location	Examinations performed at IAL
	VL > 5,000 copies/ml	HIV serological results			HIV-positive
	VL > 5,000 copies/ml	Positive	Undetermined	Negative	HIV-positive
Manaus	22	34	0	1	56
Belém	28	24	0	0	52
Fortaleza	12	20	0	3	32
Recife	13	44	0	1	57
Salvador	14	19	0	4	33
Campo Grande	10	10	0	1	20
Brasília	6	20	1	3	26
Belo Horizonte	17	32	1	1	49
São Paulo	8	62	1	1	70
Rio de Janeiro	11	17	0	0	28
Curitiba	8	35	0	10	43
Porto Alegre	14	13	0	1	27
Total	163	330	3	26	493

Sociedade Brasileira de Patologia Clínica, Rua Dois de Dezembro,78/909 - Catete, CEP: 22220-040v - Rio de Janeiro - RJ, Tel.: +55 21 - 3077-1400 / 3077-1408, Fax.: +55 21 - 2205-3386 - Rio de Janeiro - RJ - Brazil
E-mail: jbpml@sbpc.org.br

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[1] CORRESPONDING AUTHOR Márcia Jorge Castejon, Av. Dr. Arnaldo, 351, 10º andar; Cerqueira César; CEP: 01246-000; São Paulo-SP, Brasil; e-mail: marcia.castejon@ial.sp.gov.br.