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หน้าหลัก | สุขภาพดี | สุภาพสตรี | การแปลผลเลือด | โรคต่างๆ | วัคซีน
Note: This document is intended to provide guidance on the categories of viral testing and intended uses of testing for SARS-CoV-2 in light of additional testing capacity throughout the country and does not address decisions regarding payment for or insurance coverage of such testing.
การตรวจโควิดมีวัตถุประสงค์เพื่อหยุดการระบาดของโรคโดยการเลือกตรวจคัดกรองเพื่อจุดประสงค์
แนวทางในการคัดกรองนี้ขึ้นกับปัจจัยดังต่อไปนี้
แนวทางการเลือกใช้วิธีการตรวจจะใช้กับหน่วยงานที่ไม่ใช่หน่วยบริการทางการแพทย์
ในการควบคุมการระบาดของโรคมีด้วยกันหลายวิธีได้แก่
การคัดกรองอาการของโควิดโดยการสอบถามอาการ การวัดอุณหภูมิ
การสอบสวนโรคและค้นหาผู้สัมผัสจะสอบสวนหาผู้สัมผัสที่เสี่ยงต่อการติดเชื้อสูง เพื่อนำมากักตัวลดการแพร่เชื้อ
การตรวจหาเชื้อโควิด
การตรวจคัดกรองโควิด19
ขี่พลอย
ชนิดของการตรวจโควิด19
แบ่งการตรวจได้ 2 ชนิดคือ
ตรวจว่ามีการติดเชื้อหรือไม่หรือที่เรียกว่า Viral tests
เป็นการตรวจว่ามีการติดเชื้อโควิดหรือไม่ หากผลตรวจพบเชื้อแสดงว่ามีการติดเชื้อจะต้องมีการกักตัวคนที่ติดเชื้อ และสอบสวนโรคหากลุ่มคนที่สัมผัสใกล้ชิดเพื่อกักตัวและตรวจหาการติดเชื้อวิธีการตรวจมีได้สองวิธีคือ
หาผลตรวจว่าพบเชื้อจะต้องมีการสอบสวนโรคหาผู้ที่สัมผัสใกล้ชิด และมีการกักตัว
หากผลตรวจให้ผลลบแสดงว่าณ ขณะนั้นยังไม่มีการติดเชื้อ แต่ก็มีข้อพิจารณาเรื่องเวลาที่เก็บตัวอย่าง
ข้อแนะนำการปฏิบัติตัวสำหรับผู้ที่ฉีดวัคซีนครบ
หากผลตรวจให้ผลลบในคนที่ไม่มีอาการและไม่มีประวัติกับผู้ที่เป็นโควิดก็ไม่ต้องทำอะไร
Negative test results in persons without symptoms and no known exposure suggest no infection. All persons being tested, regardless of results, should receive counseling on the continuation of risk reduction behaviors that help prevent the transmission of SARS-CoV-2 (e.g., wearing masks, physical distancing, avoiding crowds and poorly ventilated spaces).
Antibody (or serology) tests are used to detect previous infection with SARS-CoV-2 and can aid in the diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) and in adults (MIS-A)2. CDC does not recommend using antibody testing to diagnose current infection. Depending on the time when someone was infected and the timing of the test, the test might not detect antibodies in someone with a current infection. In addition, it is not currently known whether a positive antibody test result indicates immunity against SARS-CoV-2; therefore, at this time, antibody tests should not be used to determine if an individual is immune against reinfection. Antibody testing is being used for public health surveillance and epidemiologic purposes. Because antibody tests can have different targets on the virus, specific tests might be needed to assess for antibodies originating from past infection versus those from vaccination. For more information about COVID-19 vaccines and antibody test results, refer to Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States.
Diagnostic testing is intended to identify current infection in individuals and is performed when a person has signs or symptoms consistent with COVID-19, or is asymptomatic, but has recent known or suspected exposure to SARS-CoV-2.
Examples of diagnostic testing include:
Screening tests are recommended for unvaccinated people to identify those who are asymptomatic and do not have known, suspected, or reported exposure to SARS-CoV-2. Screening helps to identify unknown cases so that measures can be taken to prevent further transmission.
Examples of screening include:
Public health surveillance is intended to monitor population-level burden of disease, or to characterize the incidence and prevalence of disease. Surveillance testing is primarily used to gain information at a population level, rather than an individual level, and generally involves testing of de-identified specimens. Surveillance testing results are not reported back to the individual. As such, surveillance testing cannot be used for an individual’s healthcare decision making or individual public health actions, such as isolation or quarantine.
An example of surveillance testing is wastewater surveillance.
When choosing which test to use, it is important to understand the purpose of the testing (diagnostic or screening), performance of the test within the context of the level of community transmission, need for rapid results, and other considerations (See Table 1). For example, even a highly specific antigen test may have a poor positive predictive value (high number of false positives) when used in a community where prevalence of infection is low. As an additional example, use of a laboratory-based NAAT in a community with high transmission and increased test demand may result in diagnostic delays due to processing time and time to return results. Positive and negative predictive values of NAAT and antigen tests vary depending upon the pretest probability. Pretest probability considers both the prevalence of the level of community transmission as well as the clinical context of the individual being tested. Additional information on sensitivity, specificity, positive and negative predictive values for antigen tests and antibody tests, and for the relationship between pretest probability and the likelihood of positive and negative predictive values pdf icon is available. Also see FDA’s letters to clinical laboratory staff and healthcare providers on the potential for [458 KB, 1 Page]false-positive results with antigen tests and the potential for false-negative results with molecular tests if a genetic variant of SARS-CoV-2 occurs in the part of the viral genome assessed by the test.
Table 1 summarizes some characteristics of NAATs and antigen tests to consider for a testing program. Given the risk of transmission of SARS-CoV-2 from asymptomatic and presymptomatic persons with SARS-CoV-2 infection, use of antigen tests in asymptomatic and presymptomatic persons can be considered. FDA has provided a list of FAQs for healthcare providers who are using diagnostic tests in screening asymptomatic individuals, and the Centers for Medicare & Medicaid Services will temporarily exercise enforcement discretion to enable the use of antigen tests in asymptomatic individuals for the duration of the COVID-19 public health emergency under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Laboratories that perform screening or diagnostic testing for SARS-CoV-2 must have a CLIA certificate and meet regulatory requirements. Tests that have received an EUA from FDA for point of care (POC) use can be performed with a CLIA certificate of waiver.
A tool to help healthcare providers quickly access the most relevant, actionable information to determine what type(s) of COVID-19 testing they should recommend. After test results are in, the tool can help interpret test results and guide next steps.
Intended Use
Detect current infection
Detect current infection
Analyte Detected
Viral Ribonucleic Acid (RNA)
Viral Antigens
Specimen Type(s)
Nasal, Nasopharyngeal, Oropharyngeal, Sputum, Saliva
Nasal, Nasopharyngeal
Sensitivity
Varies by test, but generally high for laboratory-based tests and moderate-high for point-of-care (POC) tests
Varies depending on the course of infection, but generally moderate-to-high at times of peak viral load*
Specificity
High
High
Test Complexity
Varies by Test
Relatively Easy to Use
Authorized for Use at the Point-of-Care
Most are not, some are
Most are, some are not
Turnaround Time
Most 1-3 days. Some could be rapid in 15 minutes
Ranges from 15 minutes to 30 minutes
Cost/Test^
Moderate (~$75-$100/test)
Low (~$5-$50/test)
Advantages
Most sensitive test method available
Short turnaround time for NAAT POC tests, but few available
Usually does not need to be repeated to confirm results
Short turnaround time (approximately 15 minutes)+
When performed at or near POC, allows for rapid identification of infected people, thus preventing further virus transmission in the community, workplace, etc.
Comparable performance to NAATs in symptomatic persons and/or if culturable virus present, when the person is presumed to be infectious
Disadvantages
Longer turnaround time for lab-based tests (1–3 days)
Higher cost per test
A positive NAAT diagnostic test should not be repeated within 90 days, because people may continue to have detectable RNA after risk of transmission has passed
May need confirmatory testing
Less sensitive (more false negative results) compared to NAATs, especially among asymptomatic people
**The decreased sensitivity of antigen tests might be offset if the POC antigen tests are repeated more frequently (i.e., serial testing at least weekly).
^ Costs for: NAATsexternal icon, Antibody testsexternal icon
+Refers to point-of-care antigen tests only.
CDC’s COVID-19 Response Health Equity Strategy outlines a plan to reduce the disproportionate burden of COVID-19 among racial and ethnic minority populations and other population groups (e.g., essential and frontline workers, people living in rural or frontier areas) who have experienced a disproportionate burden of COVID-19. One component to move towards greater health equity and to stop transmission of SARS-CoV-2 is ensuring availability of resources, including access to testing for populations who have experienced longstanding, systemic health and social inequities. All population groups, including racial and ethnic minority groups, should have equal access to affordable, quality and timely SARS-CoV-2 testing – with fast turnaround time for results — for diagnosis and screening to reduce community transmission. Efforts should be made to address barriers that might overtly or inadvertently create inequalities in testing.
In addition, completeness of race and ethnicity data is an important factor in understanding the impact the virus has on racial and ethnic minority populations. The U.S. Department of Health and Human Services has required laboratories and testing facilities to reportexternal icon race and ethnicity data to health departments, in addition to other data elements, for individuals tested for SARS-CoV-2 or diagnosed with COVID-19. Healthcare providers and public health professionals need to ask and record race and ethnicity for anyone receiving a reportable test result and ensure these data are reported with the person’s test results in order to facilitate understanding the impact of COVID-19 on racial and ethnic minority populations.
In communities with a higher proportion of racial and ethnic minority populations and other populations disproportionately affected by COVID-19, health departments should ensure there is timely and equitable access to and availability of testing with fast result return, especially when the level of community transmission is substantial or high.
Some strategies to achieve this goal include:
Positive test results using a viral test (NAAT or antigen) in persons with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19, independent of vaccination status of the person. A negative antigen test in persons with signs or symptoms of COVID-19 should be confirmed by NAAT, a more sensitive test. For more information, see the Antigen Test Algorithm.
All persons (independent of vaccination status) with positive results should isolate at home or, if in a healthcare setting, be placed on appropriate precautions. Most people with COVID-19 have mild illness and can recover at home without medical care. A symptom-based strategy to determine when to discontinue home isolation or precautions can be used for persons who are not severely immunocompromised. They should remain in isolation until they have met the criteria for discontinuing home isolation or for discontinuing precautions in a healthcare setting. For persons with COVID-19, testing is not recommended to determine when infection has resolved, when to end home isolation, or whether to discontinue precautions in a healthcare setting.
NAATs have detected SARS-CoV-2 RNA in some people’s respiratory specimens long after they have recovered from COVID-19 (>3 months). Studies have not found evidence that clinically recovered adults with persistence of viral RNA have transmitted SARS-CoV-2 to others. These findings support the recommendation for a symptom-based, rather than test-based, strategy for ending isolation of most people, so that individuals who are no longer infectious are not kept unnecessarily isolated and excluded from work or other responsibilities.
Some adults with severe illness may produce replication-competent virus beyond 10 days that may warrant extending duration of isolation and precautions. A test-based strategy may be considered in consultation with infectious disease experts for persons with severe illness or who are severely immunocompromised. For more information, including on retesting persons previously infected with SARS-CoV-2, visit Duration of Isolation and Precautions for Adults with COVID-19.
Identifying close contacts (people who have been within 6 feet for a combined total of 15 minutes or more during a 24-hour period) of persons with COVID-19 can help reduce the spread of SARS-CoV-2 in communities, workplaces, and schools when these close contacts quarantine themselves. Viral testing is recommended for individuals who are close contacts of persons with COVID-19. Fully vaccinated people who have a known exposure to someone with suspected or confirmed COVID-19 should get tested 3-5 days after exposure and are to wear a mask in public indoor settings for 14 days or until they receive a negative test result. People who are not fully vaccinated should be tested immediately after being identified, and, if negative, tested again in 5–7 days after last exposure or immediately if symptoms develop during quarantine. Most people with a history of test-confirmed COVID-19 who remain asymptomatic after recovery do not need to retest or quarantine if another exposure occurs within 90 days of their initial infection.
Negative test results using a viral test (NAAT or antigen) in asymptomatic persons with recent known or suspected exposure suggest no current evidence of infection. These results represent a snapshot of the time around specimen collection and could change if tested again in one or more days. In instances of higher pretest probability, such as high incidence of infection in the community, or a person with household or continuous contact to a person with COVID-19, clinical judgement should determine if a positive antigen result for an asymptomatic person should be followed by a laboratory-based confirmatory NAAT. Results from NAATs are considered the definitive result when there is a discrepancy between the antigen and NAAT test. For more information, see the Antigen Test Algorithm.
Because of the potential for asymptomatic and presymptomatic transmission, it is important that individuals exposed to people with known or suspected COVID-19 be quickly identified and quarantined (if unvaccinated) or wear a mask in public settings (if fully vaccinated). Regardless of vaccination status, persons with positive results should remain in isolation until they have met the criteria for discontinuing isolation. Unvaccinated persons with negative results should remain in quarantine for 14 days unless other guidance is given by the local, tribal, or territorial public health authority. Fully vaccinated persons can discontinue wearing a mask in public places once they receive a negative test, unless they live in an area of high transmission.
Based on local circumstances and resources, CDC has provided options to shorten quarantine, including the use of a test-based strategy. More information on the scientific foundation behind these recommendations is available in Options to Reduce Quarantine for Contacts of Persons with SARS-CoV-2 Infection Using Symptom Monitoring and Diagnostic Testing
Confidentiality of the individual with COVID-19 should be maintained when informing close contacts of their possible exposure to SARS-CoV-2. People are encouraged to work with public health departments investigating cases of COVID-19, including identification of close contacts.
Information to help public health departments and healthcare providers prepare for expanded viral testing in facilities after known or suspected SARS-CoV-2 exposure or when there are substantial or high levels of community transmission (Table 2) is available in CDC’s Performing Broad-Based Testing for SARS-CoV-2 in Congregate Settings.
Accumulating evidence supports ending isolation and precautions for persons with COVID-19 using a symptom-based strategy. Adults with more severe illness or who are immunocompromised may remain infectious up to 20 days or longer after symptom onset, so a test-based strategy could be considered in consultation with infectious disease experts for these people. For all others, a test-based strategy is no longer recommended except to discontinue isolation or precautions earlier than would occur under the symptom-based strategy.
Data suggest immune response to COVID-19 vaccination might be reduced in some immunocompromised people including, but not limited to, people receiving chemotherapy for cancer, people with hematologic cancers such as chronic lymphocytic leukemia, people receiving stem cells or organ transplants, people receiving hemodialysis, and people using certain medications that might blunt the immune response to vaccination (e.g., mycophenolate, rituximab, azathioprine, anti-CD20 monoclonal antibodies, Bruton tyrosine kinase inhibitors).
People who are immunocompromised should be counseled about the potential for reduced immune responses to COVID-19 vaccines and the need to continue to follow current prevention measures (including wearing a mask, staying 6 feet apart from others they don’t live with, and avoiding crowds and poorly ventilated indoor spaces) to protect themselves against COVID-19 until advised otherwise by their healthcare provider. Close contacts of immunocompromised people should also be encouraged to be vaccinated against COVID-19 to help protect these people.
Testing asymptomatic persons without recent known or suspected exposure to SARS-CoV-2 for early identification, isolation, and disease prevention
Unvaccinated persons with asymptomatic or presymptomatic infection are frequent contributors to community SARS-CoV-2 transmission and occurrence of COVID-19. Serial testing of unvaccinated persons, regardless of signs or symptoms, is a key component to a layered approach to preventing the transmission of SARS-CoV-2. Screening allows early identification and isolation of persons who are asymptomatic, presymptomatic, or have only mild symptoms and who might be unknowingly transmitting virus. Screening testing may be most valuable in areas with substantial or high community transmission levels (Table 2), in areas with low vaccination coverage, and in certain settings (see examples below).
Use of POC tests, such as antigen tests, for screening can play an important role in testing as a prevention strategy due to the short turn-around time for results. Antigen tests are most sensitive in the early stages of infection when viral loads are high and have decreasing sensitivity as disease progresses and when transmission may be less likely. The decreased sensitivity of antigen tests might be offset if the POC antigen tests are repeated more frequently (i.e., serial testing at least weekly). Thus, when screening large numbers of persons (e.g., a well-defined cohort) without known or suspected exposure to SARS-CoV-2, test sensitivity may be less critical than whether the test can be performed more frequently and provide rapid results with immediate isolation of infected individuals.3 Outbreak prevention and control are increasingly thought to depend largely on the frequency of testing and the speed of reporting (an advantage of antigen tests) and is only marginally improved – in the context of serial tests — by the higher test sensitivity of NAATs. In screening settings where antigen tests are used on asymptomatic people, laboratory-based confirmatory NAAT testing is recommended for individuals who test positive. For interpretation of screening test results, please see the Antigen Test Algorithms.
People without symptoms and without known exposure to COVID-19 do not need to quarantine while awaiting screening test results. If a person tests positive on a screening test and is referred for a confirmatory test, they should quarantine until they receive the results of their confirmatory test. For guidance on quarantine and testing of fully vaccinated people, please visit Interim Public Health Recommendations for Fully Vaccinated People.
These examples can guide development of local recommendations to prioritize unvaccinated persons for screening testing, taking into account feasibility and costs. Initial sampling of subgroups for screening testing to evaluate the need for additional screening testing in a particular group may also be considered. In communities with substantial or high levels of community transmission (Table 2), health departments should ensure resources (trained staff and testing supplies) are available to provide expanded screening testing. These examples are not listed in a priority order.
Racial and ethnic minority groups and other populations disproportionately affected by COVID-19
Teachers and staff in K-12 schools and/or childcare settings
Students, faculty, and staff at institutions of higher education (including community colleges and technical schools)
Workers in high-density worksites or worksites with large numbers of close contact to co-workers or customers (restaurant workers, transportation workers, grocery store workers)
Government workers with public interactions as part of their duties (post office workers)
First responders (police, fire, emergency medical technician (EMT)) and healthcare personnel
Residents and staff in congregate settings, such as shelters serving the homeless and correctional and detention facilities or residential settings ,such as nursing homes or those serving persons with disabilities; workplaces that provide congregate housing (fishing vessels, offshore platforms, farmworker housing or wildland firefighter camps); and military training facilities (barracks)
Persons who recently traveled, either domestic or international, and those who attended mass gatherings
Specific age groups (e.g., young adults) for whom increases have been documented early as incidence rises, especially in communities with substantial or high transmission (Table 2).
Indicator | Low | Moderate | Substantial | High |
---|---|---|---|---|
Cumulative number of new cases per 100,000 persons within the last 7 days* | <10 | 10-49 | 50-99 | ≥100 |
Percentage of NAATs that are positive during the last 7 days† | <5% | 5%-7.9% | 8%-9.9% | ≥10.0% |
Indicators should be calculated for counties or core based statistical areas, although in rural areas with low population density, multiple jurisdictions might need to be combined to make the indicators more useful for decision-making. The indicators listed can be found by county on CDC’s COVID Data Tracker Website under “county view”.
* Number of new cases in the county (or other administrative level) in the last 7 days divided by the population in the county (or other administrative level) and multiplying by 100,000.
† Number of positive tests in the county (or other administrative level) during the last 7 days divided by the total number of tests resulted in the county (or other administrative level) during the last 7 days. Calculating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Laboratory Test Percent Positivity: CDC Methods and Considerations for Comparisons and Interpretation.
Public health surveillance is the ongoing, systematic collection, analysis, and interpretation of health-related data essential to the planning, implementation, and evaluation of public health practice. See CDC’s Introduction to Public Health Surveillance.
Public health surveillance testing is intended to monitor community- or population-level outbreaks of disease or to characterize the incidence and prevalence of disease. Surveillance testing is performed on de-identified specimens, and, thus, results are not linked to individual people. Public health surveillance testing results cannot be used for individual decision-making.
Public health surveillance testing may sample a certain percentage of a specific population to monitor for increasing or decreasing prevalence or to determine the population effect from community interventions, such as social distancing. An example of public health surveillance testing is when a state public health department develops a plan to randomly select and sample a percentage of all people in a city on a rolling basis to assess local infection rates and trends.
“Wastewater,” also referred to as “sewage,” includes water from household/building use (i.e., toilets, showers, sinks) that can contain human fecal waste, as well as water from non-household sources (e.g., rainwater and industrial use). Wastewater can be tested for RNA from SARS-CoV-2. Data from wastewater testing are not meant to replace existing COVID-19 surveillance systems. Institutes of higher education with the resources to implement wastewater surveillance should develop a wastewater surveillance strategy in consultation with local public health authorities.
CDC is working with state, local, territorial, academic, and commercial partners to conduct surveillance to better understand COVID-19 in the United States and recently conducted a multistate assessment of SARS-CoV-2 seroprevalence in blood donors.
Note: This document provides guidance on the appropriate use of testing and does not dictate the determination of payment decisions or insurance coverage of such testing, except as may be otherwise referenced (or prescribed) by another entity or federal or state agency.
The purpose of this document is to provide employers with strategies for consideration of incorporating testing for SARS-CoV-2, the virus that causes COVID-19, into workplace preparedness, response, and control plans in select non-healthcare workplaces. For workplaces with healthcare personnel, including those that work in nursing homes, please refer to Interim Guidance on Testing Healthcare Personnel for SARS-CoV-2 and Interim SARS-CoV-2 Testing Guidelines for Nursing Home Residents and Healthcare Personnel.
Employers are encouraged to collaborate with state, territorial, tribal and local health officials to determine whether and how to implement the following testing strategies and which one(s) would be most appropriate for their circumstances. These considerations are meant to supplement, not replace, any federal, state, local, territorial, or tribal health and safety laws, rules, and regulations with which workplaces must comply. These strategies should be carried out in a manner consistent with existing laws and regulations, including laws protecting employee privacy and confidentiality. They should also be carried out consistent with Equal Employment Opportunity Commission (EEOC) guidanceexternal icon regarding permissible testing policies and procedures. Employers paying for testing of employees should put procedures in place for rapid notification of results and establish appropriate measures based on testing results, including instructions regarding self-isolation and restrictions on workplace access.
SARS-CoV-2 testing may be incorporated as part of a comprehensive approach to reducing transmission in non-healthcare workplaces. Symptom screening, testing, and contact tracing are strategies to identify workers infected with SARS-CoV-2, the virus that causes COVID-19, so that actions can be taken to slow and stop the spread of the virus.
COVID-19 vaccine is currently available in limited doses; therefore, CDC’s Advisory Committee on Immunization Practices (ACIP) described recommendations for prioritization during the early phases of the vaccination program. As vaccine supply increases and additional priority groups receive vaccine, CDC’s priorities for SARS-CoV-2 testing will change and the guidance will be updated. For guidance on quarantine and testing of fully vaccinated people, please visit Interim Public Health Recommendations for Fully Vaccinated People.
Employees undergoing testing should receive clear information on
Individuals tested are required to receive patient fact sheets as part of the test’s emergency use authorizationexternal icon (EUA).
According to the Americans with Disabilities Act (ADA), when employers implement any mandatory testing of employees, it must be “job related and consistent with business necessity.” In the context of the COVID-19 pandemic, the U.S. EEOCexternal icon notes that testing to determine if an employee has SARS-CoV-2 infection with an “accurate and reliable test” is permissible as a condition to enter the workplace because an employee with the virus will “pose a direct threat to the health of others.” EEOC notes that testing administered by employers that is consistent with current CDC guidance will meet the ADA’s business necessity standard. However, workplace-based testing should not be conducted without the employee’s consent. Employers who mandate workplace testing for SARS-CoV-2 infection should discuss further with employees who do not consent to testing and consider providing alternatives as feasible and appropriate such as reassignment to tasks that can be performed via telework.
The Occupational Safety and Health Administration has issued interim guidanceexternal icon for enforcing the requirements of 29 CFR Part 1904external icon with respect to the recording of occupational illnesses, specifically cases of COVID-19. Under OSHA’s recordkeeping requirements, COVID-19 is a recordable illnessexternal icon, and thus employers are responsible for recording cases of COVID-19, if the case meets certain requirements. Employers are encouraged to frequently check OSHA’s webpage at www.osha.gov/coronavirusexternal icon for updates.
Viral tests authorizedexternal icon by the Food and Drug Administration (FDA) are used to diagnose infection with SARS-CoV-2, the virus that causes COVID-19. Viral tests evaluate whether the virus is present in respiratory or other specimens. Results from these tests help public health officials identify and isolate people who are infected to minimize SARS-CoV-2 transmission. See FDA’s list of In Vitro Diagnostics Emergency Use Authorizationsexternal icon for more information about the performance of specific authorized tests.
Antibody (or serology) tests are used to detect previous infection with SARS-CoV-2 and can aid in the diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) and in adults (MIS-A). CDC does not recommend using antibody testing to diagnose current infection. Depending on the time when someone was infected and the timing of the test, the test might not detect antibodies in someone with a current infection. In addition, it is not currently known whether a positive antibody test result indicates immunity against SARS-CoV-2; therefore, at this time, antibody tests should not be used to determine if an individual is immune against reinfection. Antibody testing is being used for public health surveillance and epidemiologic purposes. Because antibody tests can have different targets on the virus, specific tests might be needed to assess for antibodies originating from past infection versus those from vaccination. For more information about COVID-19 vaccines and antibody test results, refer to Interim Clinical Considerations for Use of mRNA COVID-19 Vaccines Currently Authorized in the United States.
For more information, please refer to Overview of Testing for SARS-CoV-2.
Diagnostic testing is intended to identify current infection in individuals and is performed when a person has signs or symptoms consistent with COVID-19, or when a person is asymptomatic but has recent known or suspected exposure to SARS-CoV-2.
Examples of diagnostic testing include:
Screening tests are intended to identify infected people who are asymptomatic and do not have known, suspected, or reported exposure to SARS-CoV-2. Screening helps to identify unknown cases so that measures can be taken to prevent further transmission.
Examples of screening testing include:
When choosing which test to use, it is important to understand the purpose of the testing (e.g., diagnostic, screening), analytic performance of the test within the context of the level of community transmission, need for rapid results, and other considerations. Table 1 summarizes some characteristics of NAATs and antigen tests to consider. Most antigen tests that have received EUA from FDAexternal icon are authorized for testing symptomatic persons within the first 5, 7, 12, or 14 days of symptom onset. Given the risk of transmission of SARS-CoV-2 from asymptomatic and presymptomatic persons with SARS-CoV-2 infection, use of antigen tests in asymptomatic and presymptomatic persons can be considered. FDA has provided a list of FAQ for healthcare providers who are using diagnostic tests in screening asymptomatic individualsexternal icon, and the Centers for Medicare & Medicaid Services will temporarily exercise enforcement discretion pdf icon to enable the use of antigen tests in asymptomatic individuals for the duration of the COVID-19 public health emergency under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Laboratories that perform screening or diagnostic testing for SARS-CoV-2 must have a CLIA certificate and meet regulatory requirements. Tests that have received an EUA from FDA for point of care (POC) use can be performed with a CLIA certificate of waiver. [40 KB, 1 Page]external icon
Intended Use
Detect current infection
Detect current infection
Analyte Detected
Viral Ribonucleic Acid (RNA)
Viral Antigens
Specimen Type(s)
Nasal, Nasopharyngeal, Oropharyngeal, Sputum, Saliva
Nasal, Nasopharyngeal
Sensitivity
Varies by test, but generally high for laboratory-based tests and moderate-high for point-of-care (POC) tests
Varies depending on the course of infection, but generally moderate-to-high at times of peak viral load*
Specificity
High
High
Test Complexity
Varies by Test
Relatively Easy to Use
Authorized for Use at the Point-of-Care
Most are not, some are
Most are, some are not
Turnaround Time
Most 1-3 days. Some could be rapid in 15 minutes
Ranges from 15 minutes to 30 minutes
Cost/Test^
Moderate (~$75-$100/test)
Low (~$5-$50/test)
Advantages
Most sensitive test method available
Short turnaround time for NAAT POC tests, but few available
Usually does not need to be repeated to confirm results
Short turnaround time (approximately 15 minutes)+
When performed at or near POC, allows for rapid identification of infected people, thus preventing further virus transmission in the community, workplace, etc.
Comparable performance to NAATs in symptomatic persons and/or if culturable virus present, when the person is presumed to be infectious
Disadvantages
Longer turnaround time for lab-based tests (1–3 days)
Higher cost per test
A positive NAAT diagnostic test should not be repeated within 90 days, because people may continue to have detectable RNA after risk of transmission has passed
May need confirmatory testing
Less sensitive (more false negative results) compared to NAATs, especially among asymptomatic people
**The decreased sensitivity of antigen tests might be offset if the POC antigen tests are repeated more frequently (i.e., serial testing at least weekly).
^ Costs for: NAATsexternal icon, Antibody testsexternal icon
+Refers to point-of-care antigen tests only.
Employers may consider conducting daily in-person or virtual health checks (e.g., symptom and temperature screening) to identify employees with signs or symptoms consistent with COVID-19 before they enter a facility, in accordance with CDC’s Guidance for Businesses and Employers Responding to Coronavirus Disease 2019 (COVID-19). Employers should follow guidance from the EEOCexternal icon regarding confidentiality of medical records from health checks.
Vaccinated and unvaccinated workers with COVID-19 symptoms should be immediately separated from other employees, customers, and visitors, and sent home or to a healthcare facility, depending on how severe their symptoms are, and follow CDC guidance for caring for oneself. To prevent stigma and discrimination in the workplace, make employee health screenings as private as possible. CDC recommends that anyone with signs or symptoms of COVID-19 be tested and follow the advice of their healthcare provider. Waiting for test results prior to returning to work is recommended to keep potentially infected workers out of the workplace.
Employers are encouraged to implement flexible sick leave and supportive policies and practices as part of a comprehensive approach to prevent and reduce transmission among employees.
Positive test results using a viral test (NAAT or antigen) in persons with signs or symptoms consistent with COVID-19 indicate that the person has COVID-19. A negative antigen test in persons with signs or symptoms of COVID-19 should be confirmed by a laboratory-based NAAT, a more sensitive test. Results from NAATs are considered the definitive result when there is a discrepancy between the antigen and NAAT test. For more information, see the Antigen Test Algorithm pdf icon. Positive test results should be interpreted to indicate that a person has COVID-19 and should not come to work and should [458 KB, 1 Page]isolate at home. Decisions to discontinue isolation for workers with COVID-19 and allow them to return to the workplace may follow either a symptom-based, time-based, or a test-based strategy (see Testing to determine resolution of infection below).
Case investigation is typically initiated when a health department receives a report from a laboratory or testing site of a positive SARS-CoV-2 viral test result, or a report from a healthcare provider of a patient with a confirmed or probable diagnosis of COVID-19pdf icon. external icon
In general, fully vaccinated workers with no COVID-like symptoms do not need to quarantine or be tested following an exposure to someone with suspected or confirmed COVID-19. However, those who work in congregate settings or other high-density workplaces (e.g., meat and poultry processing and manufacturing plants) should be tested after an exposure; however, they do not need to quarantine. For more guidance on quarantine and testing of fully vaccinated people, please visit Interim Public Health Recommendations for Fully Vaccinated People.
Viral testing is recommended for all unvaccinated close contacts (people who have been within 6 feet for a combined total of 15 minutes or more during a 24-hour period) of persons with COVID-19. Because of the potential for asymptomatic and pre-symptomatic transmission of SARS-CoV-2, it is important that unvaccinated individuals exposed to people with known or suspected COVID-19 be quickly identified and quarantined. Viral testing with NAATs or antigen tests can detect if these individuals are currently infected. The health department may ask the employer for assistance in identifying close contacts of the worker. Employers are encouraged to work with public health departments investigating cases of COVID-19 and tracing contacts to help reduce the spread of SARS-CoV-2 in their workplaces and communities.
Because there may be a delay between the time a person is exposed to the virus and the time that virus can be detected by testing, early testing after exposure at a single time point may miss many infections. Testing that is repeated at different points in time, also referred to as serial testing, is more likely to detect infection among close contacts of a COVID-19 case than testing done at a single point in time. Viral testing is recommended for close contacts of persons with COVID-19 who should be tested immediately after being identified, and if negative, tested again in 5–7 days after last exposure or immediately if symptoms develop during quarantine.
While CDC continues to recommend a 14-day quarantine for unvaccinated individuals who are close contacts of a person with COVID-19, viral testing may also be used as part of an option to shorten the quarantine period. Local public health authorities determine and establish the quarantine options for their jurisdictions. Shortening quarantine may increase willingness to adhere to public health recommendations. However, shortened quarantines may be less effective in preventing transmission of COVID-19 than the currently recommended 14-day quarantine. In jurisdictions with shortened quarantine options, workplaces with higher risk of SARS-CoV-2 introduction or transmission, or with potential for greater negative impact if employees become infected SARS-CoV-2 (see Types of workplaces below), can consider restricting workers from entering the workplace until 14 days after their exposure.
Testing may also be considered for unvaccinated persons who might have been in close contact with persons diagnosed with COVID-19 in collaboration with the local health department if resources permit. A risk-based approach to testing possible contacts of a person with confirmed COVID-19 may be applied. Such an approach should take into consideration the likelihood of exposure, which is affected by the characteristics of the workplace and the results of contact investigations. In some settings, expanded screening testing (i.e., testing beyond individually identified close contacts to those who are possible close contacts), such as targeting workers who worked in the same area and during the same shift, may be considered as part of a strategy to control the transmission of SARS-CoV-2 in the workplace. High-risk settings that have demonstrated potential for rapid and widespread dissemination of SARS-CoV-2 include:
After a case of COVID-19 has been identified in a high-density critical infrastructure workplace, where workers are in prolonged close contact, NAAT or antigen testing can be used to diagnose infection in workers with known or suspected exposure to SARS-CoV-2. Employers are encouraged to consult with state, local, territorial, and tribal health departments to help inform decision-making about expanded screening testing.
If employees are tested after close contact or suspected close contact with someone who has a confirmed or probable diagnosis of COVID-19, care should be taken to inform these employees of their possible exposure to SARS-CoV-2 in the workplace while maintaining confidentiality of the individual with COVID-19, as required by the ADAexternal icon and consistent with EEOC guidance regarding What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Lawsexternal icon.
The decision to end isolation and return to the workplace for employees with suspected or confirmed SARS-CoV-2 infection should be made in the context of clinical and local circumstances. NAATs have detected SARS-CoV-2 RNA in some recovered people’s respiratory specimens for up to 3 months after illness onset but without direct evidence that virus that can replicate or cause disease. Consequently, evidence supports a time-based and symptom-based strategy to determine when to discontinue isolation or other precautions rather than a test-based strategy. For persons who are severely immunocompromised, a test-based strategy could be considered in consultation with infectious disease experts. For all others, a test-based strategy is no longer recommended except to discontinue isolation or precautions earlier than would occur under the symptom-based strategy.
Under the ADA, employers are permitted to require a healthcare provider’s noteexternal icon to verify that employees are healthy and able to return to work. However, as a practical matter, employers should be aware that healthcare provider offices and medical facilities may be extremely busy during periods when community COVID-19 indicators are in the moderate to high categorizations (Table 2) and may not be able to provide such documentation in a timely manner. In such cases, employers should consider not requiring a healthcare provider’s note for employees who are sick to validate their illness, qualify for sick leave, or to return to work. Most people with COVID-19 have mild illness, can recover at home without medical care, and can follow CDC recommendations to determine when to discontinue isolation and return to the workplace.
Screening testing of asymptomatic workers without known or suspected exposure to SARS-CoV-2 in select non-healthcare settings may be useful to detect COVID-19 early and stop transmission quickly, particularly in areas with community COVID-19 indicators in the moderate to high categorizations (Table 2, Table 3). Screening testing can be used in addition to symptom and temperature checks, which will miss asymptomatic or presymptomatic contagious workers. Persons with asymptomatic or presymptomatic SARS-CoV-2 infection are significant contributors to SARS-CoV-2 transmission.
In general, fully vaccinated workers should continue to follow employer guidance on screening testing. Please see Interim Public Health Recommendations for Fully Vaccinated People for more information.
Workplace settings for which screening testing of workers should be considered include:
Approaches may include initial testing of all workers before entering a workplace, periodic testing of workers at regular intervals, targeted testing of new workers or those returning from a prolonged absence (such as medical leave or furlough), or some combination of approaches. Given the incubation period for COVID-19 (up to 14 days), CDC recommends conducting screening testing at least weekly. Employers may find the following factors helpful to consider when determining the interval for periodic testing:
Serial testing used in a screening program could identify workers with SARS-CoV-2 infection, and thus help prevent or reduce further transmission, which is an occupational health measure of great importance in the types of workplaces mentioned above. Outbreak prevention and control is increasingly being thought to depend largely on the frequency of testing and the speed of reporting (an advantage of antigen tests) and is only marginally improved by the higher test sensitivity of NAATs. Serial testing, if implemented, should be integrated as a component of the comprehensive workplace program and not a substitute for other measures, such as COVID-19 vaccination, social distancing, mask wearing, hand hygiene, and cleaning and disinfection. Engineering controls and improved ventilation in settings such as office buildings and schools are also important.
For screening testing, some antigen test results should be considered presumptive (preliminary results). A positive antigen screening test result should be considered presumptive when the pretest probability (likelihood that the person being tested actually has the infection) for COVID-19 is low or moderate for the purpose of making a clinical diagnosis (e.g., a worker who is asymptomatic and has no known exposures to COVID-19). Asymptomatic employees who have a positive antigen screening test result should undergo a confirmatory NAAT. They should not come to work and should quarantine during confirmatory testing.
According to test manufacturers, negative antigen tests results are presumptive for the purpose of making a clinical diagnosis. A negative antigen screening test result does not need to be followed by confirmatory testing if the pretest probability is low or serial antigen testing will be performed.
NAATs do not need to be routinely repeated for confirmation. Employees with a positive NAAT result should not come to work and should isolate at home. A negative NAAT result is interpreted as no evidence of SARS-CoV-2 infection at the time when the testing sample was collected. Employees who test negative should continue to take steps to protect themselves and others.
State, local, territorial, and tribal health departments may be able to provide assistance on any local context or guidance impacting the workplace. Before testing a large proportion of asymptomatic workers without known or suspected exposure, employers are encouraged to have a plan in place for how they will ensure access to clinical evaluation and confirmatory testing when needed, ensure test results are reported to public health departments, modify operations based on test results, collaborate with public health departments in workplace case investigation and contact tracing, and manage a higher risk of false positive results in a low prevalence population.
Indicator | Low Transmission | Moderate Transmission | Substantial Transmission | High Transmission |
---|---|---|---|---|
Cumulative number of new cases per 100,000 persons within the last 7 days* | <10 | 10-49 | 50-99 | ≥100 |
Percentage of NAATs that are positive during the last 7 days† | <5% | 5%-7.9% | 8%-9.9% | ≥10.0% |
Indicators should be calculated for counties or core based statistical areas, although in rural areas with low population density, multiple jurisdictions might need to be combined to make the indicators more useful for decision-making. The indicators listed can be found by county on CDC’s COVID Data Tracker Website under “county view”.
@ If the two indicators suggest different transmission levels, the higher level should be selected.
* Number of new cases in the county (or other administrative level) in the last 7 days divided by the population in the county (or other administrative level) and multiplying by 100,000.
† Number of positive tests in the county (or other administrative level) during the last 7 days divided by the total number of tests resulted in the county (or other administrative level) during the last 7 days. Calculating Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Laboratory Test Percent Positivity: CDC Methods and Considerations for Comparisons and Interpretation.
Prevention Strategy | Low Transmission (Blue) |
Moderate Transmission (Yellow) |
Substantial Transmission (Orange) |
High Transmission (Red) |
---|---|---|---|---|
Facilitate diagnostic testing for symptomatic persons and all close contacts of cases | 1 | |||
Facilitate diagnostic testing for symptomatic persons and all close contacts of cases | 2 | |||
Implement screening testing of select groups at least weekly plus facilitate diagnostic testing of symptomatic persons and close contacts | 3 | |||
Implement screening testing of select groups at least weekly plus facilitate diagnostic testing of symptomatic persons and close contacts | 4 |