covid 19 Diagnosis test series

covid 19 Diagnosis test series

CDC has developed two laboratory tests that identify SARS-CoV-2, the virus that causes COVID-19. The first test for COVID-19 diagnosis that CDC distributed, released in February 2020, is the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, a test that accurately detects SARS-CoV-2 in respiratory specimens. CDC released a second assay in July 2020, the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, which permits public health laboratories to run three tests in a single reaction well. The Flu SC2 Multiplex is more efficient in its use of test reagents, allows higher throughput, and simultaneously gives accurate results about the presence of SARS-CoV-2, influenza A, and influenza B nucleic acid in a patient specimen. Symptoms for COVID-19 and the Flu can be similar, so testing for all three viruses at the same time will provide public health officials with information they need to help reduce the spread of these viruses in the community while conserving resources that are in short supply.

Please note: CDC will discontinue the CDC 2019-nCoV Real-time RT-PCR Diagnostic Panel at the end of 2021. For more details, please see the CDC 2019-nCoV Real-time RT-PCR Diagnostic Panel section below.

Introduction

Compared to 2002/2003 SARS-CoV and 2012–2014 MERS-CoV epidemics, COVID-19 coronavirus rapidly spread to other parts of the world (185 countries and territories, Last updated: March 21, 2020)().

In symptomatic patients, the clinical manifestations of the disease usually start after less than a week, consisting of fever (body temperature 37 to 38°C), cough, nasal congestion, and fatigue (). Pneumonia mostly occurs in the second or third week of a symptomatic infection (). Comparison of hematological parameters between mild and severe cases of COVID-19 showed significant differences in interleukin-6 (IL-6), D-Dimer, glucose (GLU), thrombin time (TT), fibrinogen (FIB) and C-reactive protein (CRP) (). Fan et al. analyzed the hematological indices of COVID‐19 infected patients between the intensive care unit (ICU) and non‐ICU patients. They showed lymphopenia and raised lactate dehydrogenase (LDH) were associated with higher rate of ICU admissions. Patients who were transferred to the ICU had a lower nadir lymphocyte count, nadir monocyte count and nadir hemoglobin, and higher peak Neutrophil (NEU) Count and peak LDH levels compared to patients who did not require ICU stay () . Many patients with MERS-CoV had liver function abnormalities with elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), and LDH (). Also laboratory data on SARS have shown that most patients had elevated CRP levels, lymphopenia, leukopenia, and elevated levels of aminotransferase, LDH and creatine kinase (). A series of recently published articles have reported the epidemiological and clinical characteristics of patients with COVID-19 disease, but data regarding the laboratory characteristics of infected individuals are limited (). This study aimed to evaluate the accuracy of laboratory parameters in predicting cases with positive RT-PCR for COVID-19.

covid 19 Diagnosis test series
    covid 19 Diagnosis test series

Methods

Study design and setting

This diagnostic accuracy study was conducted on suspected COVID-19 patients, who presented to Behpooyan Clinic Medical center in Tehran (Iran) from 22 February to 14 March, 2020. Patients were divided into two groups based on the results of real time reverse transcriptase‐polymerase chain reaction (RT-PCR) for COVID-19 and the accuracy of different laboratory parameters in predicting cases with positive RT-PCR was evaluated using area under the ROC curve (AUC). The study protocol was approved by the Ethics Committee of Shahid Beheshti University of Medical Sciences (ethical code: IR.SBMU.RETECH.REC.1399.010).

Participants

Outpatients with suspected COVID-19 having initial respiratory signs (including sore throat without shortness of breath), fever, cough, muscle ache, and headache were included ().

Data gathering

Pharyngeal swab samples were collected for COVID-19 test on presentation. Blood samples were collected from each participant and routine blood test including White blood cell count (WBC), Lymphocyte count (LYM), and Neutrophil count (NEU) were performed on the blood samples. Furthermore, blood biochemistry parameters such as Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Urea, C-reactive protein (CRP), as well as Albumin and lactate dehydrogenase (LDH) were assessed using HITACHI 7600-020 automated biochemistry analyzer.

GA COVID-19 Rapid Antigen Test

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Description: GA COVID-19 Rapid Antigen Test

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Description: COVID-19 IgG/IgM Rapid Test (Serum/Plasma/Whole Blood) is a qualitative membrane-based immunoassay for the detection of COVID-19 antibodies in serum, plasma, or whole blood. This test consists of two test lines, an IgG line and an IgM line, which is pre-coated with two mouse anti-human monoclonal antibodies separately. During testing, the sample reacts with COVID-19 antigen-coated on conjugated pad. As the complex continues to travel up the strip, the anti-COVID-19 IgM antibodies are bound on the IgM line, and the anti-COVID-19 IgG antibodies are bound on the IgG line. The control(C)line appears when sample has flowed through the strip. The presence of anti-COVID-19 IgM and/or IgG will be indicated by a visible test line in the IgM and IgG region. To serve as a procedural control, the control line should always appear if the test procedure is performed properly and the reagents are working as intended.

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Description: The Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The SARS-CoV-2 is a β -coronavirus, which is an enveloped non-segmented positive-sense RNA virus 2. It is spread by human-to-human transmission via droplets or direct contact, and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number of 2.24-3.58. Among patients with pneumonia caused by SARS-CoV-2, fever was the most common symptom, followed by cough3. The main IVD assays used for COVID-19 employ real-time reverse transcriptase-polymerase chain reaction (RT-PCR) that takes a few hours 4. The availability of a cost-effective, rapid point- of-care diagnostic test is critical to enable healthcare professionals to aid in the diagnosis of patients and prevent further spread of the virus5. Antigen tests will play a critical role in the fight against COVID-19

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Description: Healgen Rapid COVID-19 Antigen Self-Test

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Description: Healgen Rapid COVID-19 Antigen Self-Test

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Description: Healgen Rapid COVID-19 Antigen Self-Test

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Description: A rapid test for detection of antibodies (IgG and IgM) for 2019-nCoV, the novel Coronavirus from the Wuhan strain. The test is easy to perform, takes 10 minutes to provide reliable results and is higly specific to the 2019-nCoV Coronavirus.

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