210 MALAPARDIS ROAD/SUITE 103 CEDAR KNOLLS, NJ 07927-1121
Tel: (973)998-8189. Fax: (973)998-8192 CLIA ID# 31D2033824
FusionDiagnostics.com | 1-866-FusionLab Lab. Dir: George Jour M.D.
Patient: LINGAD, JOSELITO BOHOTS Client: FUSION DIAGNOSTICS 1
DoB: 10/13/1984 Age:36 Sex: M 210 MALAPARDIS ROAD
Phone: (780) 222-4530 CEDAR KNOLLS, NJ 07927
ID#: A2109050016 (973) 998-8189
Route#: 0 Page: 1 Phys:
Acc# 2109050016 Coll. Date: 09/05/21 Recv. Date: 09/05/21 Print Date: 09/06/21
Chart# Coll. Time: 11:20 Recv. Time:20:05 Print Time: 04:37
First reported on: 09/06/21 Final report date: 09/06/21
Test Name Normal Abnormal Normal Range Units
Report Status: STAT, FINAL
SARS-CoV-2 PCR
SARS-Cov-2-RT-PCR NEGATIVE NEGATIVE
Interpretation:
The iAMP COVID-19 Detection Kit is a real-time fluorescent reverse
transcription isothermal assay(PCR) intended for the qualitative detection
of
nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP), and oropharyngeal
(OP) swabs from patients suspected of COVID-19 by their health care
provider.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is
generally detectable in upper respiratory specimens during the acute phase
of infection.
Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical
correlation with patient history and other diagnostic information is
necessary to determine patient infection status.
Negative results mean that SARS-CoV-2 was not present at the limit of
detection. RNA 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.
Limitations and disclaimers:
1. This assay is for in vitro diagnostic use under FDA Emergency Use
Authorization only.
2. This test has not been FDA cleared or approved; the test has been
authorized by FDA under an Emergency Use Authorization (EUA) for use by
laboratories certified under the Clinical Laboratory Improvement Amendments
(CLIA) of 1988, 42 U.S.C. ?263a, that meet the requirements to perform
high complexity tests.
3. This test has been authorized only for the detection of nucleic acid
from SARS-CoV-2, not for any other viruses or pathogens.
4. This test is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of in
(Continued on Next Page)
210 MALAPARDIS ROAD/SUITE 103 CEDAR KNOLLS, NJ 07927-1121
Tel: (973)998-8189. Fax: (973)998-8192 CLIA ID# 31D2033824
FusionDiagnostics.com | 1-866-FusionLab Lab. Dir: George Jour M.D.
Patient: LINGAD, JOSELITO BOHOTS Client: FUSION DIAGNOSTICS 1
DoB: 10/13/1984 Age:36 Sex: M 210 MALAPARDIS ROAD
Phone: (780) 222-4530 CEDAR KNOLLS, NJ 07927
ID#: A2109050016 (973) 998-8189
Route#: 0 Page: 2 Phys:
Acc# 2109050016 Coll. Date: 09/05/21 Recv. Date: 09/05/21 Print Date: 09/06/21
Chart# Coll. Time: 11:20 Recv. Time:20:05 Print Time: 04:37
First reported on: 09/06/21 Final report date: 09/06/21
Test Name Normal Abnormal Normal Range Units
SARS-CoV-2 PCR . (Continued)
vitro diagnostic 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 the
authorization is terminated or revoked sooner.
5. Results should be used in conjunction with other data; e.g., symptoms,
results of other tests, and clinical impressions.
6. Negative results do not rule out SARS-CoV-2 infection,particularly in
those who have been in contact with the virus. Repeat testing with another
molecular diagnostic should be considered to evaluate for
active infection
in these individuals.
7. Performance of the iAMP COVID-19 Detection Kit was established for OP
and NP swab specimens only. Other specimen type have not been evaluated.
8. Improper collection, transport, or storage of specimens may impact the
ability of the assay to perform as indicated.
9. False-negative results may arise from: Improper sample
collection,storage and transport and resulting in degradation of the
SARS-CoV-2 RNA,the presence of RT-PCR inhibitors,Mutation in the SARS-CoV-2
virus,and/or failure to follow instructions for use. 10. The impacts of
vaccines, antiviral therapeutics, antibiotics,
chemotherapeutic or immunosuppressant drugs have not been evaluated.
11. The iAMP COVID-19 Detection Kit cannot rule out respiratory diseases
caused by other bacterial or viral pathogens.
________________________________ END OF REPORT __________________________
