Poor sensitivity of rapid tests for the detection of antibodies to the hepatitis B virus: implications for field studies

Cruz, Helena Medina; Scalioni, Leticia de Paula; Paula, Vanessa Salete de; Miguel, Juliana Custódio; Ó, Kycia Maria Rodrigues do; Milagres, Flavio Augusto Pádua; Cruz, Marcelo Santos; Bastos, Francisco Inácio; Flores, Priscila Pollo; Leal, Erotildes; Motta-Castro, Ana Rita Coimbra; Lewis-Ximenez, Lia Laura; Lampe, Elisabeth; Villar, Livia Melo

doi:10.1590/0074-02760160394

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Short Communication • Mem. Inst. Oswaldo Cruz 112 (3) • Mar 2017 • https://doi.org/10.1590/0074-02760160394 copy

Poor sensitivity of rapid tests for the detection of antibodies to the hepatitis B virus: implications for field studies

Authorship SCIMAGO INSTITUTIONS RANKINGS

Rapid tests (RTs) can be used as an alternative method for the conventional diagnosis of hepatitis B virus (HBV). This study aims to evaluate antibodies to HBsAg (anti-HBs) and antibodies to HBeAg (anti-HBe) RTs under different Brazilian settings. The following three groups were included: GI: viral hepatitis outpatient services; GII: low resource areas; and GIII: crack users and beauticians. Imuno-rápido anti-HBsAg^™ and Imuno-rápido anti-HBeAg^™ RTs were evaluated and showed specificities greater than 95% in all groups. The sensitivity values to anti-HBs were 50.38%, 51.05% and 46.73% and the sensitivity values to anti-HBe were 76.99%, 10.34% and 11.76% in the GI, GII and GIII groups, respectively. The assays had a low sensitivity and high specificity, which indicated their use for screening in regions endemic for HBV.

hepatitis B virus; antibodies; rapid tests; performance

Parameters	Imuno-Rápido anti-HBsAg^™				Imuno-Rápido anti-HBeAg^™

	Group I Reference centres (n = 423)	Group II Low prevalence (n = 1,526)	Group III High vulnerability (n = 381)	All groups (n = 2330)	Group I Reference centres (n = 166)	Group II Low prevalence (n = 788)	Group III High vulnerability (n = 241)	All groups (n = 1,195)
Sensitivity (CI%)	50.38% (41.63-59.10)	51.05% (46.92-55.16)	46.73% (37.05-56.59)	50.37% (46.94-53.80)	76.99% (68.18-84.39)	10.34% (48.43-18.76)	11.76% (14.57-36.41)	45.16% (38.43-51.97)
Specificity (CIs%)	99.66% (98.09-99.99)	98.01% (96.91-98.80)	98.54% (96.30-99.60)	98.42% (97.66-98.99)	96.23% (87.02-99.54)	100.00% (99.48-100.00)	100.00% (98.37-100.00)	99.80% (99.26-99.98)
PPV (CI%)	98.53% (92.09-99.96)	93.89% (90.62-96.27)	92.59% (82.13-97.95)	94.46% (91.86-96.41)	97.75% (92.12-99.73)	100.00% (66.39-100.00)	100.00% (15.81-100.00)	98.00% (92.96-99.76)
NPV (CI%)	81.41% (76.94-85.33)	76.95% (74.54-79.28)	82.57% (78.06-86.50)	78.76% (76.86-80.62)	66.23% (54.54-76.60)	89.99% (87.69-92.00)	93.72% (89.85-96.44)	89.13% (87.15-90.94)
K (CI%)	57.66% (48.36-66.96)	53.99% (49.31-58.67)	53.32% (42.58-64.06)	54.73% (50.85-58.61)	65.36% (53.66-77.06)	17.03% (0.00-34.51)	19.86% (0.00-59.13)	56.89% (49.61-64.17)
p-value	< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001	0.0047	< 0.0001
TP (n)	67	292	50	409	87	9	2	98
FN (n)	66	280	57	403	26	78	15	119
TN (n)	289	935	270	1494	51	701	224	976
FP (n)	1	19	4	24	2	0	0	2

Group	Imuno-Rápido anti-HBsAg^™			Imuno-Rápido anti-HBeAg^™

	Anti-HBs FN OD/CO mean ± SD	Anti-HBs TP OD/CO mean ± SD	p-value	Anti-HBe FN OD/CO mean ± SD	Anti-HBe TP OD/CO mean ± SD	p-value
Group I Reference centres	5.91 ± 5.44	29.56 ± 22.84	p < 0.0001	0.264 ± 0.316	0.025 ± 0.122	p < 0.0001
Group II Low prevalence	5.00 ± 6.46	35.21 ± 24.87	p < 0.0001	0.370 ± 0.357	0.099 ± 0.282	p = 0.0006
Group III High vulnerability	10.76 ± 8.98	30.60 ± 27.23	p < 0.0001	0.349 ± 0.422	0.005 ± 0.001	p = 0.1791
All groups	6.03 ± 7.02	33.67 ± 24.90	p < 0.0001	0.347 ± 0.357	0.032 ± 0.142	p < 0.001

Evaluated groups	Anti-HBs				Anti-HBe

	Sensitivity of anti-HBs rapid test according to HBV status		Sensitivity of anti-HBs rapid test according to anti-HBs titer		Sensitivity of anti-HBe rapid test according to HBV status

	Previously, HBV infected^a n (%)	HBV vaccination^b n (%)	anti-HBs titers < 100 IU/mL n (%)	anti-HBs titers ≥ 100 IU/mL n (%)	Active HBV infection^c n (%)	Previously, HBV infection^d n (%)
Group I Reference centres	28/47 (59.57)	39/86 (45.35)	7/51 (13.72)	60/82 (73.17)	84/100 (84.00)	3/13 (23.10)
Group II Low prevalence	134/176 (76.14)	158/396 (39.90)	40/268 (14.92)	252/304 (82.89)	1/1 (100.00)	8/86 (9.30)
Group III High vulnerability	15/18 (83.33)	35/89 (39.32)	2/41 (4.87)	48/66 (72.72)	1/3 (33.30)	1/14 (7.10)
All groups	177/241(73.44)	232/571 (40.63)	49/360(13.61)	360/452 (79.65)	86/104 (80.77)	12/113 (10.62)

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[1] + Corresponding author: lvillar@ioc.fiocruz.br