Cha Choong-Hwan, Kim Myeong Hee, Chung Hee-Jung, Choi Sung-Eun, Oh Heung-Bum
Department of Laboratory Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Korean J Lab Med. 2007 Oct;27(5):360-8. doi: 10.3343/kjlm.2007.27.5.360.
Human leukocyte antigen (HLA) typing based on polymerase chain reaction (PCR) is rapidly replacing the conventional serological method. This study was intended to evaluate BioSewoom HLA-A, -B, -C PCR/SSP kit (BioSewoom SSP) which had recently been developed in Korea.
A total of 158 samples from domestic (21) and international (137) HLA proficiency testing (PT) were genotyped with BioSewoom SSP, and its results were compared to consensus results. For comparison with INNO-LiPA HLA-A, -B, -C Typing Kit (INNO-LiPA, Innogenetics, Belgium), 20 samples of Koreans were genotyped with both kits for each HLA-A, -B, -C locus.
Among the 21 samples of domestic PT, BioSewoom SSP showed ambiguities as follows: 4 samples (19.0%) in HLA-A, 6 (28.6%) in HLA-B, and 1 (4.8%) in HLA-C. The ambiguities could be resolved by considering the allele distribution of Koreans. Among the 137 samples from international PT, BioSewoom SSP also showed ambiguities as follows: 12 samples (8.8%) in HLA-A, 26 (19.0%) in HLA-B and 6 (4.4%) in HLA-C. Considering the allele distribution of Koreans, the serologic equivalents obtained from BioSewoom SSP showed a full agreement with those of INNO-LiPA in all the loci tested. Twelve (0.007%) among 1,760 PCR reactions from the 21 samples of domestic PT and 20 patient samples produced faint nonspecific bands, but it was negligible. PCR failure of internal control just barely occurred (15 PCR reactions, 0.009%), but it had no bearing on allele assignment.
The performance of BioSewoom SSP was comparable to that of INNO-LiPA. All the ambiguities could be resolved by considering the allele distribution of Koreans. It is concluded that BioSewoom SSP has good performance to be used in routine HLA laboratories.
基于聚合酶链反应（PCR）的人类白细胞抗原（HLA）分型正在迅速取代传统的血清学方法。本研究旨在评估韩国最近开发的BioSewoom HLA-A、-B、-C PCR/SSP试剂盒（BioSewoom SSP）。
使用BioSewoom SSP对来自国内（21份）和国际（137份）HLA能力验证（PT）的总共158份样本进行基因分型，并将其结果与一致结果进行比较。为了与INNO-LiPA HLA-A、-B、-C分型试剂盒（INNO-LiPA，比利时Innogenetics公司）进行比较，对20份韩国人样本的每个HLA-A、-B、-C基因座分别使用这两种试剂盒进行基因分型。
在21份国内PT样本中，BioSewoom SSP出现了以下模糊结果：HLA-A中有4份样本（19.0%），HLA-B中有6份样本（28.6%），HLA-C中有1份样本（4.8%）。通过考虑韩国人的等位基因分布，可以解决这些模糊问题。在137份国际PT样本中，BioSewoom SSP也出现了以下模糊结果：HLA-A中有12份样本（8.8%），HLA-B中有26份样本（19.0%），HLA-C中有6份样本（4.4%）。考虑到韩国人的等位基因分布，BioSewoom SSP获得的血清学等效结果在所有测试基因座上与INNO-LiPA的结果完全一致。在21份国内PT样本和20份患者样本的1760次PCR反应中，有12次（0.007%）产生了微弱的非特异性条带，但可以忽略不计。内部对照的PCR失败情况极少发生（15次PCR反应，0.009%），但这与等位基因分型无关。
BioSewoom SSP的性能与INNO-LiPA相当。通过考虑韩国人的等位基因分布，可以解决所有的模糊问题。得出结论，BioSewoom SSP在常规HLA实验室中具有良好的性能，可用于此类实验室。
