Well being Departments




Assertion of goal: This toolkit is designed to supply state and native well being departments with the instruments wanted to analyze suspected instances of SARS-CoV-2 reinfection.

How investigational design meets targets: This toolkit can be utilized together with surveillance (passive or lively) for suspected instances of SARS-CoV-2 reinfection. As soon as the examine inhabitants is recognized, chart abstraction and critiques of current surveillance reporting shall be used to characterize suspected instances. Moreover, paired specimens may endure confirmatory RT-PCR, viral tradition, sgmRNA, and genomic sequencing to supply proof of reinfection.

Description of dangers: This analysis entails little to no threat to individuals. Adherence to the HIPAA Privateness Rule and deidentification of collected information will guarantee participant anonymity. If further nasal wash specimens are collected, adversarial results are anticipated to be delicate however might embrace nosebleeds and nasal irritation. If further serum is collected, adversarial results are anticipated to be delicate however might embrace hematoma or bruising. There may be additionally minimal threat to the medical professionals. For sub-studies pursuing further specimen assortment we advocate following common precautions and COVID-19 steering on specimen assortment and transport (Interim Tips for Accumulating, Dealing with, and Testing Scientific Specimens for COVID-19).

Description of anticipated advantages to the analysis participant: We anticipate that analysis individuals will profit from the improved COVID-19 prevention tips that may outcome from this analysis.

Description of the potential dangers to anticipated profit ratio: The potential dangers posed by specimen assortment are outweighed by the societal and particular person advantage of enhanced surveillance and improved prevention tips that might scale back transmission of SARS-CoV-2 inside communities.


Description and supply of examine inhabitants: The examine inhabitants can embrace all people with a suspected or confirmed case of COVID-19 throughout the surveillance catchment space or the well being division’s jurisdiction.

Investigative standards:

Prioritize individuals with detected SARS-CoV-2 RNA ≥90 days since first SARS-CoV-2 an infection:

Individuals with detected SARS-CoV-2 RNA* ≥90 days after the primary detection of SARS-CoV-2 RNA, whether or not or not signs had been current


Paired respiratory specimens (one from every an infection episode) can be found

*If detected by RT-PCR, solely embrace if Ct worth <33 or if Ct worth unavailable


Contemplate individuals with COVID-19–like signs and detection of SARS-CoV-2 RNA 45–89 days since first SARS-CoV-2 an infection:

Individuals with detection of SARS-CoV-2 RNA* ≥45 days after the primary detection of SARS-CoV-2 RNA


With a symptomatic second episode and no apparent alternate etiology for COVID-19–like signs OR shut contact with an individual identified to have laboratory-confirmed COVID-19


Paired respiratory specimens (one from every an infection episode) can be found

*If detected by RT-PCR, solely embrace if Ct worth <33 or if Ct worth unavailable


Adaptation concerns:

  • If assets are restricted, additional prioritize the sampling of individuals in high-risk teams (e.g. healthcare employees).
  • If investigating suspected reinfection instances amongst severely immunocompromised individuals, contemplate a potential examine devoted to this inhabitants, as outcomes is not going to be generalizable to the final inhabitants.

Participant exclusion standards:

  • Laboratory specimen from both first or second sickness episode is unavailable.

Estimated variety of individuals: The estimated month-to-month enrollment is anticipated to differ by jurisdiction, length of native outbreak depth, and referral testing operational elements. Contemplate taking these elements, in addition to prior variety of suspected SARS-CoV-2 instances reported, into consideration throughout native protocol adaptation.

Sampling: No a priori sampling shall be undertaken; as an alternative all suspected instances reported shall be investigated per protocol. When needed, eligibility standards could also be narrowed per adaptation concerns offered on this widespread investigation protocol.

Recruitment and Enrollment: Choices for enrollment are as comply with:

  1. Passive surveillance: Instances reported to the well being division that meet eligibility standards
  2. Energetic surveillance: Routinely analyze RT-PCR information with particular person distinctive IDs over time to establish these with recurrent optimistic exams past the given time intervals
  3. As soon as instances are recognized, optionally enroll case-patients in a sub-study to characterize the scientific course of reinfection occasions.
  4. If excited about investigating length of viral shedding, presence of replication-competent virus, and serologic response to suspected reinfection, optionally enroll case-patients in a sub-study to gather serial respiratory and serum specimens.

Description and justification of reimbursements or incentives that shall be used: Any reimbursements or incentives offered to individuals are on the discretion of the establishment utilizing this protocol.

Assertion of additional prices to individuals as a consequence of involvement within the examine: Members could incur further prices within the type of journey bills and time misplaced to interviews. These prices will solely be incurred if individuals consent to the gathering of further nasal specimens and comply with up interviews.

Procedures for implementing and documenting knowledgeable consent: At any time when acceptable, acquire knowledgeable consent from individuals that require interviews for information assortment, full 14-day symptom logs, or enroll them in a sub-study for subsequent respiratory and serum specimen assortment.




Demographics: Age (years), intercourse, race, ethnicity, occupation, and residence

Medical historical past: Immunomodulating brokers and circumstances, comorbidities, medicines acquired for first episode and subsequent episode

Scientific course: Date of preliminary sickness onset, date of preliminary scientific decision, date of symptom onset or optimistic check for suspected reinfection, stage of care acquired, length of isolation, and issues

Diagnostic check outcomes: Dates, sort of testing, platform or laboratory assay used, web site of specimen assortment, and outcomes (together with Ct worth) for all SARS-CoV-2 diagnostic exams

Epidemiologic information: Publicity historical past and residing in or visiting congregate settings

Extract these information from medical data, public well being surveillance data, or interviews, and use descriptive epidemiology to characterize the suspected instances of reinfection

Specimen Assortment:

Contemplate serial assortment of respiratory specimens and sera for suspected instances of reinfection, detailed under.

Serial respiratory specimen assortment: If participant is enrolled in a sub-study to analyze viral shedding and transmissibility, gather respiratory specimens day by day for 7 days after which each different day for 7 further days following the date of symptom recurrence or RT-PCR optimistic prognosis of suspected reinfection (if asymptomatic).

Serial serum assortment: Accumulate saved sera from first episode, any sera out there between first and second episode, and sera out there on the time of suspected reinfection. Accumulate sera at 3 days, 7 days, 14 days, 21 days and 6 weeks following suspected reinfection.

Examine devices:  

Case report kind (CRF) and information dictionary: Supplied to facilitate systematic information assortment [Appendix 1].

Coaching for all examine personnel:

Previous to utilizing the CRF, overview the corresponding information dictionary to make sure that all information are collected correctly.

Supply hyperlink