Questions 49 – 50: Did the recipient develop COVID-19 (SARS-CoV-2) since the date of last report?

SARS-CoV-2 is a novel virus belonging to the coronavirus (CoV) family that emerged in December 2019. The disease caused by this new CoV is known as COVID-19 (coronavirus disease 2019). The new virus is highly contagious and was officially declared a pandemic in March 2020. Transmission is believed to be from person to person through respiratory droplets from coughing and sneezing . Testing for COVID-19 is generally performed on specimens collected from a nasal swab or sputum sample .

As a result of the global COVID-19 pandemic, the U.S. Food and Drug Administration granted Sherlock Biosciences an emergency use of authorization (EUA) for its COVID-19 diagnostic assay, CRISPR. Although still in its infancy in real-life application, positive results by this method should be reported, even if tandem testing by other method(s) (i.e., PCR) indicate a negative result. If the CRISPR results are unclear, seek physician clarification.

Indicate whether or not the recipient has ever had a known COVID-19 (SARS-CoV-2) infection, based on a positive test result, at any time during the current reporting period.

If the recipient has had a documented COVID-19 (SARS-CoV-2) infection, report Yes and then specify the first date of the pathological diagnosis.

If the recipient has not had a documented COVID-19 (SARS-CoV-2) infection, report No.

Possible Reporting Scenarios:

Do NOT report an infection in the following scenarios:

  • A recipient only has a positive antibody result
  • The recipient was symptomatic and treated, but COVID-19 diagnostic testing was not performed and / or COVID-19 diagnostic testing was performed and negative

DO report an infection in the following scenarios:

  • A recipient has a positive COVID-19 diagnostic result (PCR or antigen) regardless of if treatment was given or if the recipient was asymptomatic
  • A recipient has a positive antibody result and a positive COVID-10 diagnostic test (PCR or antigen)

Question 51: Was a vaccine for COVID-19 (SARS-CoV-2) received?

Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) within the current reporting period.

If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively.

Revaccination Post – Infusion

When vaccines are given post-infusion, the physician should make the determination on whether the doses are part of the primary series of vaccines, third primary dose, boosters, or revaccination. If a recipient receives a new course of COVID-19 vaccines following infusion as revaccination, report the vaccines as a new series. The most up to date CDC COVID-19 vaccine information for immunocompromised people can be found here.

Questions 52 – 53: Specify vaccine brand

For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify. If the vaccine brand is unknown, leave the field blank and override the error as Unknown.

Questions 54 – 55: Select dose(s) received

For the reported dose, specify the vaccine dose the recipient in the current reporting period and specify the date when the dose was received.

Select One dose (without planned second dose) if the recipient received a single dose, without the plans of receiving the second dose and report the date of administration.

Select First dose (with planned second dose) if the recipient received their first dose, with plans for receiving the second dose and report the date of administration.

Select Second dose if this is the recipient’s planned second dose of the vaccine and report the date of administration.

Refer to the blue instructional box above for additional information regarding third and booster doses.

If the exact date is not known, use the process described in the General Instructions, Guidelines for Completing Forms and select Date estimated.

Section Updates:

Question Number Date of Change Add/Remove/Modify Description Reasoning (If applicable)
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Last modified: Sep 23, 2022

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