Segaran P. Pillai, PhD, is Director, Office of Laboratory Science and Safety, FDA Office of the Commissioner, Department of Health and Human Services, Silver Spring, MD.
Kristin W. Prentice, MS, is an Associate, and Lindsay DePalma, MS, is a Staff Life Scientist; both at Booz Allen Hamilton, Rockville, MD.
Health Secur. 2019 Jul/Aug;17(4):334-343. doi: 10.1089/hs.2019.0038.
A comprehensive laboratory evaluation of the Tetracore RedLine Alert test, a lateral flow immunoassay (LFA) for the rapid presumptive identification of was conducted at 2 different test sites. The study evaluated the sensitivity of this assay using 16 diverse strains of grown on sheep blood agar (SBA) plates. In addition, 83 clinically relevant microorganisms were tested to assess the specificity of the RedLine Alert test. The results indicated that the RedLine Alert test for the presumptive identification of is highly robust, specific, and sensitive. RedLine Alert is a rapid test that has applicability for use in a clinical setting for ruling-in or ruling-out nonhemolytic colonies of spp. grown on SBA medium as presumptive isolates of .
对 Tetracore RedLine Alert 测试进行了全面的实验室评估，该测试是一种用于快速初步鉴定 的侧向流动免疫分析（LFA），在 2 个不同的测试地点进行。该研究使用在绵羊血琼脂（SBA）平板上生长的 16 种不同的 菌株评估了该检测方法的灵敏度。此外，还测试了 83 种临床相关微生物，以评估 RedLine Alert 测试的特异性。结果表明，用于初步鉴定 的 RedLine Alert 测试具有高度的稳健性、特异性和敏感性。RedLine Alert 是一种快速测试，可在临床环境中用于排除或确认在 SBA 培养基上生长的非溶血性 spp. 作为非溶血性 的推定分离物。
