The objective of this study is to establish the shelf life of non-pasteurized whole egg, egg yolk and egg white liquid. Each sample was stored for two weeks at 5oC, 10oC, 15oC, and 25oC, and then sensory, microbial, and physicochemical tests were performed periodically. The estimation of shelf life was based on the microbial standards of total viable counts and coliforms. The chemical properties highly correlated with the sensory evaluation were also used. Our results showed that the shelf life was the most influenced by microbial properties. Exceptionally, however, whole egg and white liquid stored at 5oC and 10oC with limited bacterial growth were affected by chemical property. The shelf life of the three non-pasteurized liquids was calculated to be less than one day at over 15oC. At 5oC and 10oC, the shelf life was calculated to be 5 d and 1 d for egg yolk liquid, 5 d and 5 d for egg white, and 7 d and 5 d for whole egg, respectively. Therefore, it is advisable to establish reasonable shelf life in the more specific manner based on consideration of these findings.

The purpose of this study was to review regulatory management of the classification system and scope of veterinary medical devices in Korea. In Korea, the four categories of the classification system for veterinary medical devices (instruments, supplies, artificial insemination apparatus, and others) is somewhat differently than that for human medical devices (instruments, supplies, dental materials, and reagents for in vitro diagnostics). In 2013, veterinary medical devices were classified into approximately 1,400 items, whereas, human medical devices were classified into approximately 2,200 items. Dissimilar to human medical devices, veterinary medical devices have no individual identification codes for effective market management. In conclusion, it is necessary to introduce a device identification code system and re-examine scope of the classification system for veterinary medical devices in Korea.

본 연구에서는 국내 대표 식육인 소, 돼지, 닭, 오리의4종 식육과 염소, 양, 말, 칠면조의 4종 식육을 동시에 신속하게 감별할 수 있는 2 set의 multiplex PCR법을 개발하고자 미토콘드리아 16S RNA에서 종 특이부위를 선발하고 각 종에 대한 특이도를 높이기 위하여 인위적인 미스매치를 주어 프라이머를 제작한 후 8종 식육의 274개시료를 대상으로 특이도와 민감도를 조사하였다. 그 결과소, 돼지, 닭, 오리 모든 시료에서 각각 279, 94, 192, 477 bp의 증폭산물이, 말, 양, 염소, 칠면조의 모든 시료에서 각각 152 bp, 271 bp, 670 bp, 469 bp에서 뚜렷한 PCR 유전자 산물이 확인되어 모든 축종에서 100%의 특이도를 나타내어 축종별 감별력이 우수한 것으로 나타났다. 8종의 축종별로 DNA를 10 ng/μl으로 정량한 후 혼합물을 10배씩 단계 희석하여 반응여부를 조사한 결과, 소, 돼지, 오리에서는 100 fg까지, 닭에서는 1 pg까지 검출됨을 확인할수 있었다. 소, 돼지, 닭, 오리고기를 99.9%, 99%, 90%,70%, 50%, 30%, 10%, 1%, 0.1%의 비율로 혼합한 식육과 83℃ 20분, 100℃ 30분, 121℃ 10분에서 각각 열처리한 가열 혼합육에 대하여 검출한계를 조사한 결과 마지막단계의 희석 비율인 모든 혼합육의 0.1%에서 검출이 가능하였으며, 열처리 혼합육에서는 닭에서는 1% 농도에서소와 돼지의 혼합육에서 0.1% 농도에서 검출되어 민감도가 높음을 확인할 수 있었다. 본 연구에서 개발된 multiplex PCR법은 특이도 및 민감도에 있어서 국내 대표 식육을 감별하는데 있어서 유용한 것으로 평가된다.

In this study, we investigated and analyzed the registration, sales and regulatory management system of in vitro diagnostic veterinary medical reagents (IVDVMRs) in Korea. The registration of IVDVMRs has gradually increased since 2000, and total of 233 products from 58 companies were registered from 1975 to 2014. The market size of IVDVMRs is estimated to be approximately 12 billion Won per year from 2011 to 2013: the export sales and proportion was estimated to be 36.8% as 4.4 billion Won in 2013. Of these products, the ranking of the sales were canine heartworm, bovine tuberculosis, swine fever, porcine reproductive and respiratory syndrome, canine distemper+adenovirus+parvovirus disease, foot and mouth disease, etc. In vitro diagnostic human medical reagents were diverted biological medicine from the medical devices by the revision of the Pharmaceutical Affairs Law Enforcement Regulations in 2014 in Korea. In contrast, in vitro diagnostic devices for animal were still managed as medical devices and biological medicines, respectively. The diagnostic reagents for infectious diseases have neither classification nor grade systems. Good manufacturing practices (GMP) requirements on IVDVMRs were also exempted from the current system. This study suggested that the registration of the IVDVMRs has increased since 2005, and regulations of these devices should be improved for the effective operating system.

본 연구는 축산식품과 식중독 세균 조합의 위험순위 결정을 위한 방법으로 축산식품 관련 식중독사고 보고서(2008-2012년 자료), 축산식품 전문가의 견해, 반 정량적 위해평가 도구인 Risk Ranger 를 이용하여 문헌자료를 분석 그 결과를 비교하였다. 본 연구결과에 따르면 지난 2008년-2012년 기간 동안 국내 축산식품에서 식중독 발생 빈도가 높았던 주요 원인균은 Salmonella, Pathogenic E. coli, C. jejuni 순으로 나타났으며 Salmonella 식중독의 주요 원인 식품은 계란인 것으로 보고되었다. 그러나 국내에서 우선적으로 관리가 필요하다고 생각되는 식중독 세균/축산식품조합에 대해 축산식품 전문가들은 가장 우선적 위해 관리가 필요한 Top 5순위 중 첫 번째로 Campylobacter/계육을 제시하였고 그 다음으로 Salmonella/식용란 및 알가공품, Enterobacter sakazakii/조제분유, Pathogenic E. coli/분쇄가공육, Pathogenic E. coli/식육을 선정하였으며 Salmonella 는 식육보다는 식용란 및 알 가공품에서 우선적 위해관리가 필요함이 제시되었다. 또한 분쇄가공육, 소시지 및 햄류에 대해서는 Cl. perfringens, L. monocytogenes, S. aureus 의 3가지 병원성 미생물들의 위해관리의 필요성이 제시되었다. 또한 국외에서 개발된 반 정량적 미생물 위해평가 도구인 Risk Ranger 를 이용하여 국내 식중독발생 통계자료 및 전문가 의견 설문조사 등과 비교 분석한 결과, Risk Ranger 는 식품과 미생물 조합의 위험 순위를 간단하게 평가할 수 있는 장점이 있으나 Risk Ranger 의 결과에 영향을 주는 입력변수에 필요한 데이터가 없을 경우에 최종결과를 신뢰하기에 한계를 보였다. 특히 국내에서는 축산식품 원재료에 대해 식중독 세균의 정량적 오염수준 및 공정에 따라 오염수준에 미치는 효과에 대한 자료가 매우 부족한 것으로 나타났는데 Risk Ranger 결과, 위해순위가 0으로 나타난 경우를 분석해 보면 모니터링 자료가 없거나, 섭취 전의 조리를 통해 99% 가열이 가능한 경우였다. 최종적으로 본 연구에서는 축산식품관련 식중독 발생 통계자료, 전문가의견, Risk Ranger 분석결과를 종합적으로 분석하여 식중독 세균/축산식품 조합에 대한 위해평가 및 관리 우선대상을 순위별로 그룹화하였다. 식중독 사고 발생 및 위해 가능성이 가장 높은 위험그룹 I 에는 Salmonella spp./식용란 및 알 가공품, Campylobacter spp./계육, Pathogenic E. coli/식육 및 분쇄가공육이 선정되었으므로 차후 이들 제품에 대한 정량적 위해평가 연구가 필요할 것으로 사료된다. 본 연구결과는 차후 축산식품 및 그 가공품에 대한 정량적 미생물 위해평가의 효율성을 높이고 우선 관리 대상에 대한 과학적 근거 자료를 제시할 수 있을 것으로 사료된다.

In this study, two commercial PCR and ELISA test kits were examined for identification of eight animal species (beef, pork, chicken, duck, turkey, goat, lamb, and horse) from raw meat and meat products in Korea. The detection limit in RAW meat ELISA kit® on three types of meat samples blended with beef, pork and chicken, demonstrated that all meat species were differentiable down to 0.2%. RAW meat ELISA kit® on animal species resulted in differentiation rate of 94.5% for beef, 93.3% for pork, 90% for lamb, and 100% for chicken, duck, turkey, goat, and horse. In contrast, Powercheck Animal Species ID PCR kitTM resulted in 100% specificity at 0.05% limit of detection for all meat species. The detection limit of Cooked Meat ELISA kit® on mixed meat samples heat-treated with different temperatures and times, resulted in 0.1% for all heat-treated mixed meat except for chicken at 1.0%. Additionally, ELISA kit on sixty meat products resulted in specificity of 31.8% for ham, 13.6% for sausages, and 12.5% for ground processed products, and relatively low rate for more than 2 types of mixed meats. On the contrary, meat species differentiation using PCR kit showed higher percentage than that using ELISA kit®: 50.0% for ham, 41.7% for sausages, and 28.6% for ground processed meat. Futhermore, PCR kit on 54 dried beef meats detected pork genes in 13 products whereas ELISA kit showed negative results for all products. Hence, the possibility of cross-contamination during manufacturing process was investigated, and it was found that identical tumblers, straining trays, cutters and dryers were used in both beef and pork jerky production line, suggesting the inclusion of pork genes in beef products due to cross-contamination. In this study, PCR and ELISA test kits were found to be excellent methods for meat species differentiation in raw meat and heat-processed mixed meat. However, lower differentiation rate demonstrated in case of meat processed products raised the possibility of inclusion of other species due to cross-contamination during manufacturing process.

For the screening of Brucella antibodies in pig, 2,140 pig serum samples were collected from six slaughter house in Korea between 2006 and 2007. The Rose Bengal test (RBT) and serum agglutination test (SAT) were used for initial screening for specific antibodies to Brucella, and competitive enzyme-linked immunosorbent assay (C-ELISA) was used for confirmation of presence of serum antibody for Brucella. Overall, 575 (26.9%) samples resulted in seropositive in RBT. In SAT, 50 (2.3%) and 10 (0.5%) samples showed suspicious positive and positive reaction, respectively, however, all sera tested in this study showed a negative reaction in C-ELISA. SAT and C-ELISA might be applicable as a tool for screening of swine brucellosis.