Perryman M W, Larsen S A, Hambie E A, Pettit D E, Mullally R L, Whittington W
J Clin Microbiol. 1982 Aug;16(2):286-90. doi: 10.1128/jcm.16.2.286-290.1982.
This study evaluates the American Dade (Biokit Laboratories) rapid plasma reagin (Dade RPR) card test, currently used in Spain for the diagnosis of syphilis, which has been recently released to the U.S. market. Used as a basis for comparison with the Dade card test were the 18-mm standard rapid plasma reagin (standard RPR) card test and the Venereal Disease Research Laboratory (VDRL) slide test, using both fresh sera obtained from 505 individuals and paired serum-plasma specimens from 174 individuals. Results obtained proved the Dade RPR card test with serum to be very similar to the standard RPR card test; sensitivity was 92.3% and specificity was approximately 99% for both RPR card tests. Although the sensitivity of the VDRL slide test was lower at 88.5%, its specificity was also approximately 99%. Quantitatively, the agreement +/- 1 dilution between the two card tests was 93.6%. Agreement +/- 1 dilution between the Dade RPR card test and the VDRL slide test was 46.5% for sera, comparable to the standard RPR-VDRL agreement of 50%. In the limited evaluation of the RPR card tests with plasma, the specificity was 99.4% and the sensitivity was 100% for both tests. Quantitative agreement +/- 1 dilution between plasma and serum pairs was 100% for the Dade RPR card test. Our results showed that the Dade RPR card test is as sensitive and as specific as the standard RPR card test. Therefore, it was concluded that one card test has no particular advantage over the other.
本研究评估了目前在西班牙用于梅毒诊断、最近已投放美国市场的美国达德（生物试剂盒实验室）快速血浆反应素（达德RPR）卡片试验。作为与达德卡片试验比较的基础，采用了18毫米标准快速血浆反应素（标准RPR）卡片试验和性病研究实验室（VDRL）玻片试验，使用了从505名个体获得的新鲜血清以及174名个体的配对血清-血浆标本。所获得的结果证明，血清达德RPR卡片试验与标准RPR卡片试验非常相似；两种RPR卡片试验的敏感性均为92.3%，特异性均约为99%。虽然VDRL玻片试验的敏感性较低，为88.5%，但其特异性也约为99%。定量分析，两种卡片试验之间相差±1个稀释度的一致性为93.6%。血清的达德RPR卡片试验与VDRL玻片试验之间相差±1个稀释度的一致性为46.5%，与标准RPR-VDRL的一致性50%相当。在对血浆RPR卡片试验的有限评估中，两种试验的特异性均为99.4%，敏感性均为100%。达德RPR卡片试验中血浆和血清配对之间相差±1个稀释度的定量一致性为100%。我们的结果表明，达德RPR卡片试验与标准RPR卡片试验的敏感性和特异性相同。因此，得出的结论是，一种卡片试验相对于另一种没有特别优势。
