73 lines
3.6 KiB
Markdown
73 lines
3.6 KiB
Markdown
---
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type: test-result
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category: travel
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person: Xuewei Jiang
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date: 2021-12-17
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source: test_result_jiang.pdf
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---
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# COVID-19 Test Result — Jiang Xuewei
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## Lab Information
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| Field | Value |
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|-------|-------|
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| Lab | Genentox Labs / Nova Diagnostics Labs |
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| Address | 2001 E 1st St Ste 109, Santa Ana, CA 92705 |
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| Phone | 833-668-2522 |
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| CLIA# | 05D0871568 |
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| Lab Director | Rosaura Williams MD |
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| Email | results@novadxlabs.com |
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| Report Type | Final Report — SARS RT-PCR FLY |
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## Patient Information
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| Field | Value |
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|-------|-------|
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| Name | Jiang, Xuewei |
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| DOB | 03/13/1993 |
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| Gender | Female |
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| Address | 11950 Idaho Ave. Apt. 113, Los Angeles, CA 90025 |
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| MRN | EJ4954380 |
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## Sample Information
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| Field | Value |
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|-------|-------|
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| Collected | 12/17/2021 11:02 |
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| Received | 12/17/2021 |
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| Reported | 12/17/2021 |
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## Clinic Information
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| Field | Value |
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|-------|-------|
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| Client | Chinese Consulate |
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| Site | LAX Walk In |
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| Physician | Maxwell Y Jen |
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## Detailed Results Summary
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| Specimen ID | Test | Specimen Type | Results | Expected Value |
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|-------------|------|---------------|---------|----------------|
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| 391192 | SARS CoV-2 (Covid-19) by RT-PCR (NAAT) | Nasopharyngeal Swab | Not Detected (negative) | Not Detected |
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| 391193 | COVID-19 IgM (Chemiluminescence) | Venous Blood Draw | Detected (1.11 s/co) | <1 |
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| 391194 | N-Protein | Blood Drop | Not Detected | Not Detected |
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**Resulted By:** Eyas Mousa
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**Date:** 12/17/2021
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**Final Result for SARS CoV-2 (COVID-19): NOT DETECTED (negative)**
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> Note: IgM was Detected (1.11 s/co) which is above the expected value of <1, but the overall final result was still NOT DETECTED (negative) based on the RT-PCR (NAAT) test.
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## Disclaimers
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Not Detected (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. Collection of multiple specimens or types of specimens may be necessary to detect virus. Improper specimen collection and handling, sequence variability under primers/probes or viruses present below the limit of detection may lead to false negative results. Positive and negative predictive values of testing are highly dependent on prevalence. False negative test results are more likely when prevalence is high.
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This test has been authorized by the FDA under an Emergency Use Authorization (EUA). The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2 under Section 564(b)(1) of the Act, 21 U.S.C. section 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. FDA review of the validation is pending.
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The SARS-CoV-2 test is intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria. Testing methodology is (Real Time) RT-PCR. The assay targets the S, N and ORF1ab genes. Test results must be correlated with clinical presentation and evaluated in the context of another laboratory and epidemiologic data. Test performance can be affected because the epidemiology and clinical spectrum of infection caused by SARS-CoV-2 is not fully understood.
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Genentox Laboratories, LLC. DBA Nova Diagnostics Labs CLIA Certification Number: 05D0871568 is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform high complexity tests.
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