Puerto Rico Public Health Laboratories

Edificio A P.O. Box 70184 San Juan, PR 00936

Lic. No. 1 CLIA #40D0672312
Tel. (787) 765-2929, ext. 3755

SARS-CoV-2 (COVID-19 VIRUS) ANTIGEN SCREENING TEST

NAME: Mary Hibet Torres Velez

CONTROL No.:
S.S.: 0197

DoB: 04-25-1956 AGE: 66 SEX: F INITIATIVE: COVID-RESPOND

ADDRESS: Palomas Calle A #45 Yauco,Puerto Rico

EVENT TYPE: COVID-19 SCREENING
TELEPHONE: 787-518-3518

Collected by: Joel Collazo Huertas Reported by: Gabriela M Acosta Orta
Title: RN/TM Title: RN/TM
Date: 05-05-2022 Time: 12:40 AM Date: 05-05-2022 Time: 03:09 PM

SPECIMEN TYPE: NASAL/NASOPHARINGEAL SWAB

TEST RESULT REFERENCE VALUE
POSITIVE
SARS-CoV-2 (COVID-19 VIRUS)
NEGATIVE NEGATIVE
ANTIGEN
INVALID

Methodology: Lateral flow immunoassay BINAXNOW CLARITY BD VERITOR PLUS CARESTART

Interpretation: Positive: COVID-19 Antigen was detected

Negative: No COVID-19 antigen detected or is below the detection limit of the test. All negative results
are considered presumptive.

Limitations of use:
1. This test detects both viable (live) and non-viable SARS-CoV-2. The test performance depends on the amount of
virus in the sample.
2. A negative test result may occur if the level of antigen in a sample is below the detection limit of the test. All results
should be considered in conjunction with other available clinical information.
3. Negative results, from patients with symptoms onset beyond seven days and asymptomatic patients should be
treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be
performed.
4. Positive test results do not rule out co-infections with other pathogens.
5. The presence of mupirocin may interfere with the BinaxNOW COVID-19 Ag test and may cause false negative test
results.
6. This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by
laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
7. Results from antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or
to inform infection status

Important Notes:
1. Diagnostic testing for SARS-CoV-2 is intended to identify current infection at the individual level and is performed
when a person has signs or symptoms consistent with COVID-19, or when a person is asymptomatic but has recent
known or suspected exposure to SARS-CoV-2.
2. Screening testing for SARS-CoV-2 is intended to identify infected persons who are asymptomatic and without
known or suspected exposure to SARS-CoV-2. Screening testing is performed to identify persons who may be
contagious so that measures can be taken to prevent further transmission.