Description
Saliva: A Non-invasive, Reliable Testing Specimen
COVID testing with saliva samples is non-invasive, easy, and safe. Patients can reliably self-collect samples, minimizing viral exposure to health personnel. The simple collection method reduces the risk of errors made in more complicated sampling procedures, which lead to false negatives or costly repeat testing.
In contrast, deep nasopharyngeal (NP) swabs are invasive and uncomfortable for patients. They can induce sneezing or coughing in patients, which is hazardous to everyone in the vicinity, especially the healthcare workers administering the test. Specialized training is required to perform the collection protocol.
Researchers have found saliva as sensitive, if not more, than NP swabs for detection and diagnosis of SARS-CoV-2. Saliva and NP swabs in VTM also demonstrated equivalence in our internal validation study.
Low-cost, High-throughput Viral RNA Extraction
The 10X Enzymatic DNA/RNA Extraction Buffer enables fast and efficient viral detection, and maintains sensitivity through concentrating the lysis buffer to remove sample dilution effects. Enzymes digest RNase, protecting RNA from degradation for maximum yield, and PCR inhibition is minimized for successful downstream molecular processing.
The buffer removes the need for expensive and manually-intensive RNA purification steps and associated consumables, allowing more samples to be processed in a day and reducing the cost per extraction to $1/sample. Adding the extraction buffer to the sample inactivates the virus immediately, eliminating the risk of viral exposure to lab professionals.
Accurate, Sensitive Results
Carry-over contamination, where amplicons leftover from previous runs contaminate subsequent ones, is a common cause of false positives in PCR testing. Our UNG carry-over prevention system uses Uracil-DNA Glycosylase (UNG) to increase accuracy by degrading those amplicons within the PCR mixture.
The assay uses PCR technology, the gold standard and most sensitive method of COVID detection. It reduces inconclusive results and the need for repeat testing. A viral infection can be detected in as little as 5.8 viral copies/µL.
Intended Use
The Chai COVID-19 Saliva Dx Test Kit is a RT-qPCR test intended for the qualitative detection of the SARS-CoV-2 virus in upper and lower respiratory specimens including nasopharyngeal swabs in viral transport media (VTM), and saliva specimens collected without preservatives in a sterile container. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in respiratory specimens during the acute phase of infection. Positive results indicate the presence of SARS-CoV-2 RNA. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results indicate that the amount of SARS-CoV-2 present in the initial sample is lower than the limit of detection.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for public health decisions. Negative results should be combined with patient history, clinical observations and epidemiological information.
The COVID-19 Saliva Dx Test Kit is intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Chai COVID-19 Saliva Dx Test Kit has been validated by Chai pursuant to the FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. FDA’s independent review of this validation is pending.
