ÀÚµ¿È ¸Åµ¶°Ë»çÀÎ Mediace Rapid Plasma Reagin (RPR) °Ë»çÀÇ ¼º´ÉÆò°¡
Evaluation of the Performance of Rapid Plasma Reagin (RPR) Assay as Automated Syphilis Test
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¼Õº¸¶ó(Son Bo-Ra) - ÃæºÏ´ëÇб³ ÀÇ°ú´ëÇÐ Áø´Ü°Ë»çÀÇÇб³½Ç
½Å°æ¼·(Shin Kyeong-Seob) - ÃæºÏ´ëÇб³ ÀÇ°ú´ëÇÐ Áø´Ü°Ë»çÀÇÇб³½Ç
Abstract
¿¬±¸¸ñÀû : ÀúÀÚµéÀº ÀÚµ¿ÈµÇ°í Á¤·®°Ë»ç¸¦ ÇÒ ¼ö ÀÖ´Â ºñÆ®·¹Æ÷³×¸¶ ¸Åµ¶ °Ë»ç½Ã¾àÀÎ Mediace¢â R PR (Sekisui Chemical Co., Ltd, Tokyo, Japan)ÀÇ ¼º´ÉÀ» Æò°¡ÇÏ°íÀÚ ÇÏ¿´´Ù.
´ë»ó ¹× ¹æ¹ý : ¼ö±â RPR Ä«µå(ASAN Pharm. Co., Ltd., Seoul, Korea)¿¡ ¾ç¼º°á°ú¸¦ º¸ÀÎ 68°³ÀÇ È¯ÀÚ °Ëü¸¦ Æ÷ÇÔÇÑ 188°³ÀÇ °Ëü¸¦ ´ë»óÀ¸·Î ÇÏ¿´´Ù. Mediace RPR °Ë»çÀÇ ¼º´ÉÀ» Æò°¡Çϱâ À§ÇØ Á¤¹Ðµµ, Á÷¼±¼º ¹× ¼ö±â RPR Ä«µå, TPLA ¹× FTA-ABS °Ë»ç¿ÍÀÇ »ó°ü¼ºÀ» ºÐ¼®ÇÏ¿´´Ù.
°á °ú : Mediace RPR °Ë»çÀÇ Àϳ» Á¤¹Ðµµ ¹× ÀÏ°£ Á¤¹Ðµµ´Â º¯ÀÌ°è¼ö°¡ °¢°¢ 4.48%¿Í 4.84% À̾ú´Ù. ±×¸®°í 0¿¡¼ 7.3 R.U.¿¡¼ Á÷¼±¼ºÀÌ À¯ÁöµÇ¾ú´Ù. RPR Ä«µå, TPLA ¹× FTA-ABS °Ë»ç¿ÍÀÇ »ó°ü¼º °Ë»ç¿¡¼ Mediace RPR °Ë»çÀÇ ¿¹¹Îµµ ¹× ƯÀ̵µ´Â °¢°¢ 100%¿Í 96.9% À̾ú´Ù. RPR Ä«µå¿Í ÀÏÄ¡µµ´Â 96.8% À̾ú´Ù.
°á ·Ð : Á¤¹Ðµµ, Á÷¼±¼º, ¿¹¹Îµµ ¹× ƯÀ̵µ¸¦ Æ÷ÇÔÇÏ´Â Mediace RPR °Ë»çÀÇ ¼º´ÉÀº ¿ì¼öÇÏ¿´´Ù. ±×·¯¹Ç·Î ÀÓ»ó°Ë»ç½Ç¿¡¼ ¸Åµ¶ÀÇ ¼±º°°Ë»ç¿¡ Mediace RPR °Ë»çÀÇ Àû¿ëÀº ¸Å¿ì À¯¿ëÇÒ °ÍÀ¸·Î »ç·áµÈ´Ù.
Purpose: We evaluated the performance characteristics of Mediace Rapid Plasma Reagin (RPR) (Seikisui Chemical Co., Ltd, Japan), an automated and quantitative method for the syphilis diagnosis.
Materials and Methods: 188 samples were analyzed, including 68 sera from patient with positive results in manual RPR card (ASAN Pharm. Co., Ltd., Seoul, Korea). To evaluate the performance of Mediace RPR assay, a precision, linearity and comparison study with manual RPR card, TPLA and FTA-ABS were analyzed.
Results: Within-run and between-run coefficients of variation were 4.48% and 4.84%, respectively. Linearity ranged from 0 to 7.3 R.U. In comparison study with manual RPR, TPLA and FTA-ABS IgM, the sensitivity and specificity of Mediace RPR assay was 100% and 96.9%, respectively. Overall agreement with RPR card was 96.8%.
Conclusions: The performance of Mediace RPR assay, including precision, linearity, sensitivity and specificity, were excellent. Therefore, the routine application of this test to screen syphilis may be useful in the clinical laboratory.
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ÀÚµ¿ÈµÈ Mediace RPR °Ë»ç, ¼ö±â RPR °Ë»ç, ¸Åµ¶, Æò°¡
Automated Mediace RPR assy, Manual RPR card, Syphilis, Evaluation
KMID :
0390320140240010075
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