分子诊断实验室
The University of Denver 分子诊断实验室 (MDL) provides high-quality, highly specific 和 highly accurate public health laboratory services for the University, 丹佛市和县, 以及科罗拉多州.
Under the leadership of Professor Phil Danielson 和 Lead Scientist Vicente Contreras, the MDL has developed saliva-based testing capabilities for every strain 和 variant of SARS-CoV-2 as well as a host of other viral communicable diseases including influenza. 自2021年1月起, the MDL has processed more than half a million saliva samples, with an average turnaround time of less than 24 hours.
In addition to the Saliva Express testing, the Spit Lab is proud to be designated a National Wastewater Surveillance System Center of Excellence by the 疾病控制中心 和 预防. We partner with the State of Colorado 和 municipal water utilities to provide subject matter expertise.
认证
The MDL is proud to be accredited by the College of American Pathologists, which demonstrates that we meet their high st和ards for laboratories 和 rank among the top laboratories nationwide.
测试方法
The MDL began by examining samples using a method called "direct from saliva." The saliva sample is placed directly into a polymerase chain reaction (PCR) 和 within hours you know the results of the test. 然而, when working with real-world samples — some containing things like leftover food 和 blood — many of the samples were failing, meaning they were unable to recover sufficient viral RNA that could then be tested. The MDL then began using an extraction-based approach where saliva is run through an automated process that neutralizes the chemicals that attack the RNA in saliva. We are now able to separate the “garbage” from the RNA in the samples providing a more accurate result.
Our data suggests that SARS-CoV-2 is detectable in extracted saliva PCR samples days before it is detectable in nasopharyngeal PCR samples. The overall concordance of the Spit Test to the comparator nasopharyngeal PCR test is 99.7% measured within 7,520 paired saliva 和 nasopharyngeal samples. Sensitivity of spit to nasopharyngeal was 94.4% 和 specificity of spit to nasopharyngeal sample was 99.8%. Our comparator test was the National Jewish 健康 RT-PCR nasopharyngeal evaluation for SARS-CoV-2. The MDL utilizes the TaqPath Combo Kit with a salivary sample instead of a nasopharyngeal sample 和 utilization of a Beckman Coulter extraction machine 和 RNAdvance for extraction. 吐槽测试证明了96.7% sensitivity, a specificity of ≈100%, 和 98.总协议数3%. It provides for an improved limit of detection compared to similar tests.