March 17th, 2021
SAN DIEGO, Calif.—
Yale School of Public Health approved Alcala Labs as a designated Lab under EUA 202097 S007. SalivaDirect™ is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test intended for the qualitative detection of nucleic acid from SARSCoV-2 in saliva collected without preservatives in a sterile container from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories designated by the Yale School of Public Health, Department of Epidemiology of Microbial Diseases, that includes the Clinical Molecular Diagnostics Laboratory, Department of Pathology, Yale School of Medicine, located at 310 Cedar St., New Haven, CT 06510, that are also certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meet the requirements to perform high complexity tests.
Results are for the detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in saliva specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. 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 do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. Negative results for SARS-CoV-2 RNA from saliva should be confirmed by testing of an alternative specimen type if clinically indicated.
SalivaDirect™ is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of RT-qPCR and in vitro diagnostic procedures. The assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The COVID-19 virus RNA in saliva remains stable at room temperature for at least 7 days. If cold storage is available: to mitigate fluctuations in temperatures, samples can also be stored at 2-8°C until sample transport or processing (up to 7 days) or at -80°C for longer term storage.
Click here for more information on ordering the test: http://www.alcalalabs.com/infectious-disease-testing/
February 24th, 2021
SAN DIEGO, Calif.—
The CDC and the California Department of Public Health have recently updated their COVID-19 quarantine recommendations for persons who have been fully vaccinated. OCHCA will update its health order in accordance with this guidance:
COVID-19-vaccinated persons with exposure to someone with suspected or confirmed COVID-19 are not required to quarantine if they meet all of the following criteria:
· Are fully vaccinated, having received either both doses of a two-dose series ≥2 weeks prior to COVID-19 exposure or one dose of a single-dose vaccine ≥2 weeks prior to COVID-19 exposure
· Are within 90 days following receipt of the last dose in the series, AND
· Have remained asymptomatic since the current COVID-19 exposure
Persons who do not meet all 3 of the above criteria should continue to follow current quarantine guidance after exposure to someone with suspected or confirmed COVID-19.
Fully vaccinated persons who do not quarantine should still:
· Self-monitor for symptoms of COVID-19 for 14 days following an exposure.
· Seek clinical evaluation if they develop symptoms, including SARS-CoV-2 testing if indicated.
· Respond to calls or texts from OCHCA to assist in contact tracing efforts if requested to do so.
These criteria could also be applied when considering work restrictions for fully vaccinated healthcare personnel with higher-risk exposures, including household exposures, as a strategy to alleviate staffing shortages; however, if no staffing shortages exist, healthcare workers should still quarantine after higher-risk exposures until further data is available about the effectiveness of vaccination in reducing transmissibility. Of note, exposed healthcare personnel would not be required to quarantine outside of work.
Fully vaccinated inpatients and residents in healthcare settings should continue to quarantine according to guidance for healthcare settings following an exposure to someone with suspected or confirmed COVID-19; outpatients should be cared for using appropriate Transmission-Based Precautions.
All vaccinated persons must continue to adhere to social distancing and masking measures in the community and job-specific PPE in work site settings.
For more information, see CDC’s clinical considerations for use of COVID-19 vaccine.
Testing of Asymptomatic Persons Who are Fully Vaccinated:
The CDC and CDPH have not modified their recommendations for laboratory screening of asymptomatic persons who are fully vaccinated. OCHCA continues to strongly recommend routine screening of asymptomatic staff and residents of nursing homes.
In other settings where routine screening is being performed, such as schools, hospitals, and workplaces, consideration can be given to focusing screening on those who have not completed a vaccine series.
Fully-vaccinated persons who develop symptoms consistent with COVID-19 should be tested and isolated pending results.