Guzmán María G, Pelegrino José L, Pumariega Tania, Vázquez Susana, González Léster, Kourí Gustavo, Arias Jorge
Instituto de Medicina Tropical, Departamento de Virología, Centro Colaborador OPS/OMS para el Estudio de las Enfermedades Víricas, Ciudad de La Habana, Cuba.
Rev Panam Salud Publica. 2003 Dec;14(6):371-6. doi: 10.1590/s1020-49892003001100001.
To report the results from participating laboratories for four external quality control proficiency tests of dengue serological diagnosis that were carried out in the Region of the Americas in the period of 1996-2001.
External quality control proficiency tests of dengue serological diagnosis were carried out in 1996-1997, 1998-1999, 1999-2000, and 2000-2001. Panels made up of 20 serum samples (12 of them positive for dengue IgM antibodies) were sent to participating laboratories in the Region. The sera were negative for HIV antibodies, hepatitis C virus antibodies, and hepatitis B surface antigen. The sera were stored at -20 degrees C until they were sent in refrigerated shipments to the participating laboratories. The presence of IgM antibodies was determined through IgM-capture enzyme-linked immunosorbent assay (ELISA), while the IgG antibody titer was determined by hemagglutination inhibition or by IgG ELISA. The results of the IgM antibody testing that differed from those of the reference center were considered discordant. The IgG antibody titer was considered discordant when the results differed by two dilutions or more with respect to the reference center's results.
A total of 27 laboratories received a total of 59 serum panels over the 1996-2001 period, and the results from testing 54 of those panels (91.5%) were sent back in. Of the total of 1 080 sera samples from those 54 panels, the results from 95.6% of the IgM antibody tests were concordant with the results from the reference center. With 47 of the 54 panels (87.0%) the participating laboratories' agreement with the reference center's results for the IgM antibody testing was 90.0% or higher. The laboratories sent back results from a total of 27 IgG antibody titer tests, and 22 of them (81.5%) coincided with those from the reference center. Considering the IgM antibody testing results from the four periods, the findings from 22 of the participating laboratories coincided with those from the reference center for at least 90% of the samples, and 13 of the laboratories were in complete concordance with the reference center.
The majority of the participating laboratories showed an excellent level of performance in detecting dengue IgG and IgM antibodies. However, the deficiencies found in some instances confirm the need for continuing to improve laboratory diagnosis of dengue in the Region of the Americas.
报告1996 - 2001年期间在美洲地区进行的四项登革热血清学诊断外部质量控制能力验证试验中各参与实验室的结果。
在1996 - 1997年、1998 - 1999年、1999 - 2000年和2000 - 2001年进行了登革热血清学诊断外部质量控制能力验证试验。由20份血清样本（其中12份登革热IgM抗体呈阳性）组成的样本组被送往该地区的参与实验室。这些血清的HIV抗体、丙型肝炎病毒抗体和乙型肝炎表面抗原均为阴性。血清保存在 -20℃，直至冷藏运输至参与实验室。通过IgM捕获酶联免疫吸附测定（ELISA）检测IgM抗体的存在，而IgG抗体滴度则通过血凝抑制试验或IgG ELISA进行测定。与参考中心结果不同的IgM抗体检测结果被视为不一致。当结果与参考中心的结果相差两个或更多稀释度时，IgG抗体滴度被视为不一致。
在1996 - 2001年期间，共有27个实验室收到了总共59个血清样本组，其中54个样本组（91.5%）的检测结果被反馈回来。在这54个样本组的总共1080份血清样本中，95.6%的IgM抗体检测结果与参考中心的结果一致。在54个样本组中的47个（87.0%）中，参与实验室在IgM抗体检测方面与参考中心结果的一致性达到90.0%或更高。实验室共反馈了27份IgG抗体滴度检测结果，其中22份（81.5%）与参考中心的结果相符。考虑四个时期的IgM抗体检测结果，22个参与实验室的检测结果与参考中心至少90%的样本结果相符，13个实验室与参考中心完全一致。
大多数参与实验室在检测登革热IgG和IgM抗体方面表现出优异的水平。然而，在某些情况下发现的不足之处证实了在美洲地区继续改进登革热实验室诊断的必要性。
