StageZero COVID-19 PCR Saliva Testing LABORATORY RESULTS

LABORATORY RESULTSStageZero COVID-19 PCR Saliva Testing

Pat

ien

t

Sp

ecim

en

Pro

vid

er

Name: Phone #: Patient ID #:

Fasting Status: Gender Birthdate: Age:

Height: Weight: BMI: Prev. BMI:

Collection Time: Specimen ID:

Collection Date: Report Type:

Received Date: Report Date:

Requesting Provider

Client ID:

John Partick Doe 09:15

2020-10-08 F

ZALZALA, SAJAD, MDRoot Cause Medical835 Mason St, STE 250Dearborn, MI 48124

02864

Test Results

Test Description

Clinical Recommendations

Disclaimers

Result Interpretation

TaqPath™COVID-19 Combo Kit

ORF1ab POSITIVE

N gene NEGATIVE

S gene NEGATIVE

MS2 POSITIVE *

Status Valid

Result SARS-CoV-2 Not Detected

Specimen Type saliva

COVID-19 Result : SARS-CoV-2 Not Detected

SARS-CoV-2 RNA was not detected. Consider testing for other viruses.

* MS2 is the assay’s internal control, indicating that PCR amplification occurred ifthere is no detectable SARS-CoV-2 during the analysis.

TaqPath™ COVID-19 Combo Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (rRT-PCR)test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, andbronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. StageZero has internallyvalidated test kit performance for detection of SARS-CoV-2 in saliva.

Please discuss these results with your physician.

Results are for the identification of SARS-CoV-2 RNA. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinicalcorrelation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not ruleout bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within theUnited States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.Negative results must be combined with clinical observations, patient history, and epidemiological information.

This test has not been FDA cleared or approved. This test is performed by StageZero in our CLIA-certified high complexity laboratory, usinga PCR-based test kit that has been granted emergency use authorization by FDA for detection of SARS-CoV-2 in nasopharyngeal swab,nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens during the acute phase of infection. StageZero has internallyvalidated test kit performance for detection of SARS-CoV-2 in saliva. This test has been authorized only for the detection of nucleic acid fromSARS-CoV-2, not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitrodiagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless theauthorization is terminated or revoked sooner.

Dr. Leroy D. Mell, Jr. | Laboratory Director | CLIA No. 49D2059683 | NPI No. 1437710415©2020 StageZero Life Sciences | 8751 Park Central Drive, Suite 200 | Richmond, VA 23227 | www.StageZeroLifeSciences.comPage 1

Rpt ver: SZLS 1.0Ref ver: 2.0

Source:


Pat

ien

t

Sp

ecim

en

Pro

vid

er







Requesting Provider

Client ID:


2020-10-08 F


02864



Source:


Pat

ien

t

Sp

ecim

en

Pro

vid

er







Requesting Provider

Client ID:


2020-10-08 F


02864



Source:

Documents

StageZero COVID-19 PCR Saliva Testing LABORATORY RESULTS