Rapid Turnaround, Home-based Saliva Testing for COVID-19

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04568122

Enrollment

1277

Registered

2020-09-29

Start date

2020-11-20

Completion date

2022-12-10

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Brief summary

The aim of the study is to demonstrate the feasibility and validity of a saliva based home surveillance monitoring test for SARS-CoV-2 infection. Participants will be asked to carry out as many tests as are included in the bag they are provided, on a daily basis until they are used up.

Interventions

DEVICESaliva test kit

Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Enrollment is to a single group. Specific eligibility criteria apply depending on whether the participant is a hospitalized patient, in high-risk or infected population, or low-risk population

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Hospitalized patients * Hospitalized at Stanford Health Care for COVID-related complications and tested positive for SARS-CoV-2 with a PCR-based test * Able to understand and consent to study and with a clinical trajectory likely to be consistent with multi-day participation * High-risk/positive population * Seeking testing for suspected COVID or a participant in a study of COVID-positive outpatients * Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos. * Willing to participate in the study for 6 months * Low-risk population * Own an internet-enabled phone or device capable of loading web pages, receiving text messages, and taking/uploading photos. * Willing to participate in the study for 6 months

Exclusion criteria

* All participants: * Participants with salivary gland dysfunction (including patients with Sjogren's disease or those with xerostomia associated with lupus or rheumatoid arthritis) * Participants will not be eligible if they identify any reason they are unable to participate in the study * High-risk/positive population * Participants who have color blindness * Participants unable to operate the SnapDx device * Low-risk population * Participants with prior confirmed SARS-CoV-2 infection * Participants who have color blindness * Participants unable to operate the SnapDx device

Design outcomes

Primary

Measure	Time frame	Description
Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability	Up to 5 days per participant	Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.
Number of Positive Home Saliva Tests as Determined by the Patient	Up to 5 days per participant	Validity Outcome.

Secondary

Measure	Time frame	Description
Number of Participants That Called Technical Support	Up to 5 days per participant	Feasibility Outcome (ease of use). Number of participants that called technical support, by reason (e.g., processing was not possible due to broken part).
Sample Integrity	Up to 5 days per participant	Feasibility Outcome. The participants were asked to determine whether the saliva sample filled up to the indicated line, and if there were bubbles present as a measure of sample integrity.
Participant-rated Confidence in Interpreting Results	Up to 5 days per participant	Validity Outcome (ease of interpretation). Number of participants responding by category when asked to provide a rating on being Confident in Interpreting Results.
Specificity of Sample Test Kit	Up to 5 days per participant	Validity Outcome. Analysis of saliva samples provided by participants and run through sample test kit by study lab. Specificity = number of true negatives out of negative tests run. Samples may have been split and run through more than one test.
Sensitivity of Sample Test Kit	Up to 5 days per participant	Validity Outcome. Analysis of saliva samples provided by participants and run through sample test kit by study lab. Sensitivity = number of true positives out of the positive tests run. Samples may have been split and run through more than one test.
Participant-rated Ease of Use	Up to 5 days per participant	Validity Outcome (ease of use). Number of participants responding by category when asked to provide a rating on SnapDx being Easy to Learn to Use.

Countries

United States

Participant flow

Pre-assignment details

1277 participants signed consent; 353 were allocated to a study arm: participants who came to the study site to collect a kit (First, Second, and Third Distribution groups) or provided saliva samples (Positive Saliva Collection and Negative Saliva Collection groups).

Participants by arm

Arm	Count
Saliva Test - First Distribution Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.	94
Saliva Test - Second Distribution Participants provide two test samples at home using the saliva test kit to detect the SARS-CoV-2 virus.	112
Saliva Test - Third Distribution Participants provide one test sample at study visit using the saliva test kit to detect the SARS-CoV-2 virus.	135
Positive Saliva Collection Participants provide one saliva sample confirmed positive for SARS-CoV-2 virus used in lab to validate device function.	9
Negative Saliva Collection Participants provide one saliva sample confirmed negative for SARS-CoV-2 virus used in lab to validate device function.	3
Total	353

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004
Overall Study	Lost to Follow-up	48	44	4	0	0

Baseline characteristics

Characteristic	Total	Saliva Test - First Distribution	Saliva Test - Second Distribution	Saliva Test - Third Distribution	Positive Saliva Collection	Negative Saliva Collection
Age, Continuous	46.11 years STANDARD_DEVIATION 4.65	38.8 years STANDARD_DEVIATION 15.8	46.8 years STANDARD_DEVIATION 20.6	52.6 years STANDARD_DEVIATION 17	23.8 years STANDARD_DEVIATION 5.1	24.3 years STANDARD_DEVIATION 5.51
Ethnicity (NIH/OMB) Hispanic or Latino	53 Participants	23 Participants	20 Participants	10 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	293 Participants	66 Participants	91 Participants	124 Participants	9 Participants	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants	5 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Asian	64 Participants	13 Participants	24 Participants	21 Participants	4 Participants	2 Participants
Race/Ethnicity, Customized Black or African American	6 Participants	3 Participants	2 Participants	1 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized More than one race	14 Participants	6 Participants	8 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	5 Participants	0 Participants	5 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Other	28 Participants	10 Participants	8 Participants	10 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized White	234 Participants	60 Participants	65 Participants	103 Participants	5 Participants	1 Participants
Region of Enrollment United States	353 participants	94 participants	112 participants	135 participants	9 participants	3 participants
Sex: Female, Male Female	217 Participants	42 Participants	73 Participants	91 Participants	8 Participants	3 Participants
Sex: Female, Male Male	136 Participants	52 Participants	39 Participants	44 Participants	1 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 94	0 / 112	0 / 135	0 / 9	0 / 3
other Total, other adverse events	0 / 94	0 / 112	0 / 135	0 / 9	0 / 3
serious Total, serious adverse events	0 / 94	0 / 112	0 / 135	0 / 9	0 / 3

Outcome results

Primary

Number of Matched Test Colormetric Interpretation as a Measure of Interrater Reliability

Feasibility Outcome. Discrepancy in interpretation of colormetric readout by participant versus by technician via photo. Passed test = void of manufacturing or user error.