What steps to take if you suspect a COVID-19 infection
The Maryland Department of Health Laboratory is testing locally using the Centers for Disease Control and Prevention (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel which has been approved for emergency use authorization (EUA) by the Federal Food and Drug Administration (FDA).
Clinicians considering testing of persons with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or use COVID-19 diagnostic testing, authorized by the Food and Drug Administration under an Emergency Use Authorization (EUA) through clinical laboratories.
Priorities for testing include:
· PRIORITY I
o Any symptomatic individual
· PRIORITY II
o Asymptomatic individuals where COVID-19 exposure may be possible, including:
- Contacts of confirmed COVID-19 cases (e.g., contact tracing, outbreak or cluster investigation).
- Residents and staff of congregate living settings and long-term care facilities (e.g., nursing homes, assisted living facilities, residential programs and group homes serving individuals with developmental disabilities, behavioral health residential programs and group homes, dormitories, housing shelters, detention or correctional facilities)
· PRIORITY III
o Healthcare workers and first responders (e.g., emergency medical service personnel, home health care workers, and law enforcement personnel)
· PRIORITY IV
o Patients, especially high-risk unstable patients, whose care would be altered by a diagnosis of COVID-19.
· PRIORITY V
o Individuals employed in close contact settings (e.g., retail, public transport, school, childcare, camp, food service or processing, personal services, or for children attending school, camp, or child care, and manufacturing).
· PRIORITY VI
o Individuals previously in a large gathering.
Based on a public health cluster, outbreak, or contact tracing investigation, an individual may be directed by the Maryland Department of Health (MDH) or a local health department to be tested
COVID-19 Testing Priorities Guidance Memo (6-22-2020)
SARS-CoV-2/Influenza Multiplex RT-PCR Testing Announcement Memo
On the MDH Laboratories Administration test order form you MUST indicate the specimen’s Priority Level.
The MDH Laboratories Administration will continue to conduct COVID-19 testing in support of local health departments for outbreak and death investigations.
Updated Interim Guidance and Instructions for Submission of Specimens for Suspected COVID-19 Infections: Testing at the Maryland Department of Health (MDH) Laboratory
Please note: At present (02/24/2020) the naming of the CDC 2019-nCoV real time PCR assay cannot be changed to SARSCoV-2 until a formal application is made to the FDA to modify the Emergency Use Authorization (EUA) package insert for this assay.
Coronavirus (COVID-19) Specimen Collection and Shipping Guidance
Specimen Types - Following recent CDC guidelines only one upper respiratory specimen, a Nasopharyngeal (NP) Swab, is necessary to be collected from outpatients for COVID-19 testing. An Oropharyngeal specimen (OP) is as an acceptable specimen type if NP swabs are not available. Collection of two specimen types, lower respiratory and upper respiratory, is still recommended for hospitalized patients for COVID-19 testing. CDC also recommends testing lower respiratory tract specimens, if available. Specimens should be collected as soon as possible once a PUI is identified regardless of symptom onset. Currently, the MDH Laboratories Administration is not accepting nasal mid-turbinate (NMT) swab or anterior nares specimens as recently recommended by the CDC until data is made available by the CDC or others that indicate these are reliable specimen types for COVID-19 pcr testing. Maintain proper infection control when collecting specimens. Refer to chart below for collection and storage instructions.
Viral Transport Media Specimen Collection and Packaging Guidance for COVID-19
Specimen Collection & Storage Instructions
Lower Respiratory (sputum, bronchoalveolar lavage, and tracheal aspirate)
For bronchoalveolar lavage and tracheal aspirates collect 2-3 ml into a leak-proof, sterile, screw cap sputum collection cup or sterile dry container. Refrigerate at 2-8°C and ship on ice pack to the Maryland Department of Health Laboratory. For sputum collections, have the patient rinse their mouth with water and then expectorate deep cough sputum directly into a leak-proof, sterile, screw cap sputum collection cup. The induction of sputum is not recommended. When it is clinically indicated (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage sample should be collected and tested as a lower respiratory tract specimen.
Upper respiratory (nasopharyngeal swab (NPS))
(oropharyngeal swab (OP) e.g. throat swab)
Nasopharyngeal Wash/Aspirate or Nasal Aspirate
Collect a nasopharyngeal swab in a viral transport media tube (2-3ml). Use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts as they may inhibit PCR testing or inactivate some viruses. Insert a swab into the nostril parallel to the palate. Insert a swab into nostril parallel to the palate. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it. Place swab, after collecting patient specimen, directly into 2-3 ml of viral transport media. Refrigerate specimens at 2-8°C and ship on ice pack to the Maryland Department of Health Laboratory.
Swab the posterior pharynx, avoiding the tongue.
If both NP and OP swabs both are collected, they should be combined in a single tube to maximize test sensitivity and limit testing resources.
For NP wash/aspirate or nasal aspirate, collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. Refrigerate specimen at 2-8°C and ship on ice pack to the Maryland Department of Health Laboratory.
Specimen collection kits (Viral Culture Kit) can be ordered by the local health department by calling 443-681-3777 and submitting via email or fax the Outfit Supply Requisition form. (See link below)
Completing the MDH Laboratory Test Request Form
The MDH Laboratories Administration Form # 4676 Infectious Agents: Culture /Detection must be completed and submitted with each of the recommended specimens (1) lower respiratory and (2) upper respiratory.
Click an example of the completed form #4676 and the electronic fillable form.
Packaging and Shipping
Specimens must be packaged in a triple packaging system to ensure that under normal conditions of transport they cannot break, be punctured or leak their contents (Refer to page 9 in the Lab Services Guide)
To request COVID-19 testing for a suspect case, health care providers must contact the MDH Infectious Disease Bureau at 410-767-6700 during business hours and after hours call the MDH Emergency Call Center at 410-795-7365 to arrange the initial disease consultation.
For questions or concerns, please contact the Division of Molecular Biology Laboratory at 443-681-3924 or 443-681-3800 during normal business hours from 8:00AM-4:30PM.