Diagnostic Approaches for COVID-19 and Its Associated Complications
Abstract
:1. Introduction
1.1. Structure and Etiology of Coronavirus
1.2. Severity and Subsequent Need for Hospitalization
1.3. Sampling
2. Materials and Methodology
3. Diagnostics and Complications
3.1. D-dimer, Coagulation Factors, and Troponin
3.2. Inflammation, Immune Response, and Cytokine Storm
3.3. Other Risk Factors, Comorbid Disease, and Organ Failure
3.4. RT-PCR Sampling Site, Methodology, and Testing Capacity
3.5. Chest CT-Scan
3.6. Serological Testing
Measured Parameter(s) | Results | Ref. |
---|---|---|
VWF | • Patients in ICU having even higher VWF than hospitalized patients | [32] |
↑Thrombomodulin | • Increased in-hospital mortality | [32] |
↑D-dimer | • >1 μg/mL led to increased bleeding or thrombosis | [10] |
• >1.56 μg/mL led to increased mortality | [26] | |
• Pediatric patients in the ICU had the highest D-dimer followed by patients in the hospital and outpatient individuals | [27] | |
• Increased coagulation disorders and thrombi formation | [28,29] | |
• Formed clots that were firmer than in COVID-19 negative patients | [29] | |
• >1.5 μg/mL had 85% sensitivity, 88.5% specificity detecting VTE | [30] | |
• Increased risk for thrombosis | [31] | |
↑D-dimer, ↑CRP | • More correlated with RV dysfunction compared to ↑hs-cTn1 | [40] |
↑D-dimer, ↑PT, ↑aPTT, ↓fibrinogen | • High coagulating state followed by fibrinolytic state due to consumption of coagulation factors | [36,37,38] |
Factor V | • Factor V was elevated (>150 IU/dL) in initial SARS-CoV-2 infection | [34] |
• Low factor V (>150 IU/dL) correlated with higher mortality | [34] | |
• Factor V is positively correlated with viral load in men and weakly negatively correlated with viral load in females | [34] | |
↓Factor V, aPTT | • Lowered factor V led to abnormal aPTT waveform, showing DIC reaction leading to coagulopathy. | [34] |
• The DIC-like reaction seen in COVID-19 is through a non-classical pathway that leads to a DIC-like response | [35] | |
↓Factor V, ↓ Factor VII | • In terminal stage patients | [34] |
↑Factor VII | • >200 IU/dL can increase mortality | [34] |
↑Factor VIII | • Seen in COVID-19 positive patients with a 307% increase showing coagulopathy | [32,34] |
Factor X | • Factor X is unaltered in COVID-19 | [34] |
↑PT | • Correlated with complications predicted by APACHE II, SOFA, and qSOFA scores | [28] |
↑Anti-phospholipid antibodies | • Indicates increase coagulopathy | [33] |
↑hs-cTn1 | • In severe COVID-19, indicates myocardial infarction and RV dysfunction | [39] |
↑LDH, ↑CRP, ↑D-dimer, ↑bilateral pulmonary infiltrates | • Determining ICU admission and predicting mortality | [42] |
↑IL-6 | • Severe COVID-19 patients had a greater increase than non-severe COVID-19 patients | [42] |
• Optimal threshold is 0.795 μg/L | [43] | |
↑IL-6, ↑fibrinogen | • IL-6 and fibrinogen can cause coagulopathy | [29] |
↑IL-6, ↑IL-2, ↑IL-10, ↑INF-γ | • Predicts disease severity | [44] |
↑IL-6, ↑TNF-1, ↑IL-8 | • Increased organ damage, vasculature (multiple micro-thrombosis), pulmonary (pulmonary fibrosis), nervous (headache and loss of smell and taste), and cardiovascular (myocardial infarction) | [51,52] |
↓Lymphocytes | • Hospitalization, increased COVID-19 severity • Underlying lung inflammation | [39,46] |
↓Lymphocytes, ↑CRP | • Predicted hospitalization | [42] |
↑Leukocytes, ↑neutrophils, ↓lymphocytes, ↓eosinophils | • Diabetic patients at increased risk for infection and worsened outcomes | [47] |
↑Neutrophil, ↑neutrophil-lymphocyte ratio, ↑ALT, ↑creatinine, ↑fibrinogen | • Increased inflammation and organ damage in hypertensive patients | [54] |
↓Calcium | • Increase organ injury, septic shock, and worsened 28-day mortality | [53] |
↑BUN, ↑AST, ↑ALT | • Organ damage present with SARS-CoV-2 infection, most likely acute kidney injury | [26,42] |
Study | Experimental Test | Control Test | Results | Ref. | |
---|---|---|---|---|---|
Sensitivity (%) | Specificity (%) | ||||
Profiling early humoral response to diagnose novel coronavirus disease (COVID-19) | ELISA (IgA, IgM) | RT-PCR, patient symptoms, CT-scan | IgA—93.3I gM—90.4 | IgA—100 IgM—100 | [46] |
Diagnostic value and dynamic variance of serum antibody in coronavirus disease 2019 | CLIA (IgG, IgM) | RT-PCR | IgG—88.9 IgM—48.1 | IgG—90.9 IgM—100 | [64] |
Development and clinical application of a rapid IgM–IgG combined antibody test for SARS-CoV-2 infection diagnosis | Immunoassay (IgG, IgM), LFIA | RT-PCR | Overall—88.66 | Overall—90.63 | [65] |
A peptide-based magnetic chemiluminescence enzyme immunoassay for serological diagnosis of coronavirus disease 2019 | MCLIA (IgG, IgM, IgG-IgM) | RT-PCR | IgG—71.4I gM—57.2 IgG-IgM—81.5 | IgG—100 IgM—100 IgG-IgM—100 | [64] |
Evaluation of enzyme-linked immunoassay and colloidal gold- immunochromatographic assay kit for detection of novel coronavirus (SARS-Cov-2) causing an outbreak of pneumonia (COVID-19) | ELISA or GICA (IgG, IgM, IgG-IgM) | WHO diagnostic criteria | ELISA(IgG)—82.5 ELISA(IgM)—44.4 ELISA(IgG-IgM)—87.3 GICA(IgG)—81.3 GICA(IgM)—57.1 GICA(IgG-IgM)—82.4 | ELISA(IgG)—100 ELISA(IgM)—100 GICA(IgG)—100 GICA(IgM)—100 | [67] |
Serological diagnostic kit of SARS-CoV-2 antibodies using CHO-expressed full-length SARS-CoV-2 S1 proteins | ELISA (IgM, IgG) | Control group * | Overall—99.7 | Overall—97.5 | [68] |
Performance of VivaDiag COVID-19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID-19 in acute patients referring to emergency room department | LFIA | RT-PCR | Inpatient—83.3 Outpatient—18.4 | Inpatient—100 Outpatient—91.7 | [69] |
Evaluation of nine commercial SARS-CoV-2 immunoassays | ELISA, LFIA | RT-PCR | ELISA—65–90 LFIA—83–90 | ELISA—93–100 LFIA—100 | [70] |
4. Alternative Testing and Future Perspectives
5. Different COVID-19 Diagnostic Tests, Their Advantages and Limitations
5.1. Reverse-Transcription Polymerase Chain Reaction (RT-PCR)
5.2. Loop-Mediated Isothermal Amplification (LAMP)
5.3. Lateral Flow
5.4. Enzyme-Linked Immunosorbent Assay (ELISA)
6. Conclusions
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
Abbreviations
ACE2 | angiotensin-converting enzyme-2 |
ALT | alanine aminotransferase |
APACHE II | acute physiology and chronic health evaluation II |
aPTT | activated partial thromboplastin time |
AST | aspartate transaminase |
BUN | blood urea nitrogen |
CARMEN | combinatorial array reactions for multiplexed evaluation of nucleic acids |
CLIA | chemiluminescence immunoassay |
CRISPR | clustered regularly interspaced short palindromic repeats |
CRP | c-reactive protein |
CURB-65 | acute confusion, urea concentrations, respiratory rate, blood pressure, age > 65 |
DETECTR | DNA endonuclease targeted CRISPR trans reporter |
DIC | disseminated intravascular coagulation, |
ELISA | enzyme-linked immunosorbent assay |
GICA | colloidal gold-immunochromatographic assay |
HbA1c | hemoglobin A1chs-cTn1—high-sensitivity cardiac troponin-1 |
IL | interleukin |
INF-γ | interferon gamma |
LDH | lactate dehydrogenase |
LFIA | lateral flow immunoassay |
MCLIA | magnetic chemiluminescence enzyme immunoassay |
MERS-CoV | Middle East respiratory syndrome coronavirus |
NADH/NADPH | nicotinamide adenine dinucleotide/nicotinamide adenine dinucleotide phosphate |
PaO2/FiO2 | partial pressure of oxygen in blood over fraction of inhaled oxygen |
PSI | pneumonia severity index |
PT | prothrombin time |
PTH | parathyroid hormone |
qSOFA | quick sepsis related organ failure assessment |
RT-LAMP | reverse transcriptase loop-mediated isothermal amplification |
RT-PCR | reverse transcriptase polymerase chain reaction |
RT-qPCR | quantitative RT-PCR |
RV | right ventricular |
SARS-CoV-2 | severe acute respiratory syndrome coronavirus-2 |
SHERLOCK | specific high-sensitivity enzymatic reporter un-locking |
SOFA | sequential organ failure assessment |
TNF-1 | tumor necrosis factor-1 |
VTE | venous thromboembolism |
VWF | von Willebrand factor |
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PSI Score | Mortality Risk (%) | Treatment Strategy |
---|---|---|
≤70 | 0.6–0.7 | Outpatient |
70–90 | 0.9–2.8 | Outpatient |
91–130 | 8.5–9.3 | Brief Hospitalization |
>130 | 27–31.1 | Intensive Care Unit (ICU) |
CURB-65 | Criterion |
---|---|
C | Acute Confusion |
U | Urea > 18 mg/dL |
R | Respiratory Rate > 30 RPM |
B | Systolic blood pressure ≤ 90 mmHg or diastolic blood pressure ≤ 60 mmHg |
65 | Age ≥ 65 |
Technology | Molecule Tested | LB or POC | Time to Results | Typical Sample Site | Number of Samples Tested Per Batch |
---|---|---|---|---|---|
RT-PCR | viral RNA | LB | 3–4 h | Nasopharyngeal swab, sputum | Up to 96 samples (lab based) |
LAMP | viral RNA | LB or POC | 2–3 h | Nasopharyngeal swab, sputum | 96 samples or 1–4 samples at Point of Care. |
Lateral Flow | Antibody | POC | 15–20 m | Blood for antibody testing | 1 patient sample |
ELISA | Antibody | LB | 1–3 h | Blood for antibody testing | Up to 96 samples |
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Wang, I.E.; Cooper, G.; Mousa, S.A. Diagnostic Approaches for COVID-19 and Its Associated Complications. Diagnostics 2021, 11, 2071. https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112071
Wang IE, Cooper G, Mousa SA. Diagnostic Approaches for COVID-19 and Its Associated Complications. Diagnostics. 2021; 11(11):2071. https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112071
Chicago/Turabian StyleWang, Ivan E., Grant Cooper, and Shaker A. Mousa. 2021. "Diagnostic Approaches for COVID-19 and Its Associated Complications" Diagnostics 11, no. 11: 2071. https://0-doi-org.brum.beds.ac.uk/10.3390/diagnostics11112071