Result Code Information*

*updated June 30, 2021

Test turnaround time: within 24 hours of receipt at Broad

Broad CRSP releases results as soon as they are ready, 24/7.  In CareEvolve, Negative results are sent automatically via email to participants with information on how to register and view results. TNPs, Inconclusives, Invalids and Positives are delivered to the sites' results ordering/delivery system -- not directly to the participants. There is no automatic notification for TNPs, Inconclusives, Invalids and Positives. Each site must check their system regularly and directly communicate non-negative results to participants.

If participants have any questions regarding their test results, they should contact their COVID test site administrator.

The Broad CRSP lab delivers the following results for individual and pooled PCR tests:

Individual PCR Test Results

Result

Definition

POSITIVE

Positive for detection of 2019-novel Coronavirus (2019-nCoV) by qRT-PCR.

NEGATIVE

2019-novel Coronavirus (2019-nCoV) not detected by the qRT-PCR assay. Consider testing for other respiratory viruses or re-collecting for 2019-nCoV testing. Note: Optimum timing for peak viral levels during infections caused by 2019-nCoV have not been determined. Collection of multiple specimens from the same patient may be necessary to detect the virus.

INVALID

This specimen failed to produce a valid result. An Invalid result can mean that no nucleic acids (viral or human) were detected, or that the result otherwise did not meet our quality control specifications. Recommend re-collection of specimen.

INCONCLUSIVE

Inconclusive for SARS-CoV-2 by RT-PCR with one of the two viral probes (either N1 or N2) being detected while the other is not detected. Recommend re-collection of specimen.

UNSATISFACTORY/TNP

Test Not Performed. A new sample must be submitted to the laboratory in order to receive a confirmed test result. See chart below for Unsat/TNP Reason Codes


Pooled PCR Test Results

Result

Definition

PRESUMPTIVE POSITIVE

Pool is positive for detection of SARS-CoV2 by RT-PCR. Initiate individual diagnostic testing of pool members.

NEGATIVE

SARS-CoV2 not detected by RT-PCR. Individual re-testing not indicated at this time.

INVALID

This specimen failed to produce a valid result. An Invalid result can mean that no nucleic acids (viral or human) were detected, or that the result otherwise did not meet our quality control specifications. Individuals in the pool must be treated as “presumptive positive” until such time that they receive a negative result. Initiate re-testing of pool members.

INCONCLUSIVE

Inconclusive for SARS-CoV-2 by RT-PCR with one of the two viral probes (either N1 or N2) being detected while the other is not detected.  Individuals in the pool must be treated as “presumptive positive” until such time that they receive a negative result.  Initiate re-testing of pool members.

UNSATISFACTORY/TNP

Test Not Performed.  A new sample must be submitted to the laboratory in order to receive a confirmed test result. See chart below for Unsat/TNP Reason Codes

 

Unsatisfactory/TNP (Test Not Performed) Reason Codes

When the laboratory issues a TNP result, there will be an Unsatisfactory code associated to explain the reason for the TNP:

UNSATISFACTORY_1

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: improper specimen transport medium.

Applies to samples submitted in media.  The media cannot be pipetted (too viscous).

UNSATISFACTORY_2

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: inappropriate timing of collection relative to specimen received.

Samples are submitted beyond their authorized and/or stability time limits.

UNSATISFACTORY_3

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: sample tube unlabeled.

Sample tube is unlabeled and cannot be matched to an order.

UNSATISFACTORY_4

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: insufficient volume.

Applies to samples submitted in media. The tube is either empty or does not contain enough media volume to perform the test.

UNSATISFACTORY_5

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: tube sample data does not match the submission form.

This is used when the order and tube label do not match.

UNSATISFACTORY_6

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: laboratory incident.

This is used when a test can not be performed due to a laboratory error and the sample must be resubmitted.

UNSATISFACTORY_7

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: leaking/broken tube.

This is used for broken or leaking tubes. Very similar to reason #10, but this is used for samples submitted in media.

UNSATISFACTORY_8

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: sample not received.

This is used when we have an electronic or physical order in hand but do not receive a physical specimen.

UNSATISFACTORY_9

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: incomplete requisition.

This is used when required elements of the requisition are missing and we are unable to obtain the information before the sample expires, or if there is not enough information to know who to reach out to for the missing information.

UNSATISFACTORY_10

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: specimen tube received uncapped or broken.

This is used in cases where the sample arrives in an uncapped or broken tube.

UNSATISFACTORY_11

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: sample unsuitable for automated processing.

The first step in processing is to add media to the swab. After adding media, some samples are too viscous to process. This most often happens when the patient does not blow their nose before collecting the sample, resulting in excessive mucus. This reason may also be used if we cannot read the barcode on the tube.

UNSATISFACTORY_12

Unsatisfactory for 2019-novel Coronavirus (2019-nCoV) testing by PCR: swab collection not to submission standards.

This is used when the swab is upside down in the tube, there are multiple swabs in the tube, or when there is no swab in the tube.

CANCELED

Testing canceled per submitter.

Canceled by ordering provider.