SARS-CoV-2 Antigen Rapid Test Kit (DTS922)

Regulatory status: For research use only, not for use in diagnostic procedures.

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Whole blood, serum or plasma
Intended Use
The SARS-COV-2 Antigen Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of SARS-COV-2 Antigen in human whole blood, serum or plasma, thus as an aid in the diagnosis of COVID-19 infections. The test is for research use only.
The original packaging should be stored at 4-8°C. Avoid light, keep dry and do not freeze. The test kit is stable for 12 months in the sealed pouch.
Performance Characteristics
Physical appearance:
1. The components in this kit are neat and complete in appearance, no burrs, no damage, no pollution; the material is firmly attached; the label has clear writing and no damage.
2. Film strip width: Film strip width not less than 2.5 mm.
3. Travel speed: Not less than 10mm/min.
Extracted three batches of SARS-COV-2 Antigen Rapid Test Kit, each batch of at least 10 parts of people, repeat positive samples detected at least 10 times. 3 batches of test results should be consistent. Take any one of the negative samples for 10 times and the results are all negative.
Detection Limit
1:5 dilution of a N protein in 10ug/mL was diluted by 6 gradients then tested. The result showed the sensitivity was 3ng/mL.
The test has tested 5 positive human serum samples, and the test results showed that all was positive; and 10 healthy human samples were tested, and the test results were negative.
General Description
Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by infection with the SARS-CoV-2 virus. Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In severe cases, infection can cause pneumonia, severe acute respiratory syndrome (SARS), kidney failure and death. Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The 2019 Novel Coronavirus, formerly known as 2019-nCoV and now known as SARS-COV-2, is a new strain of coronavirus that was first identified during an outbreak in Wuhan, China which started in December 2019.


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Does "Flattening the Curve" Affect Critical Care Services Delivery for COVID-19? A Global Health Perspective


Authors: Gilardino, Ramiro E.

During this coronavirus disease 2019 (COVID-19) global pandemic, nations are taking bold measures to mitigate the spread of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections in order to avoid the overwhelming its critical care facilities. While these "flattening the curve" initiatives are showing signs of impeding the potential surge in COVID-19 cases, it is not known whether these measures alleviate the burden placed on intensive care units. Much has been made of the desperate need for critical care beds and medical supplies, especially personal protective equipment (PPE). But while these initiatives may provide health systems time to bolster their critical care infrastructure, they do little to protect the most essential element - the critical care providers. This article examines bolder initiatives that may be needed to both protect crucial health systems and the essential yet vulnerable providers during this global pandemic.

Headache: A striking prodromal and persistent symptom, predictive of COVID-19 clinical evolution


Authors: Caronna, Edoardo; Ballve, Alejandro; Llaurado, Arnau; Jose Gallardo, Victor; Maria Ariton, Diana; Lallana, Sofia; Lopez Maza, Samuel; Olive Gadea, Marta; Quibus, Laura; Restrepo, Juan Luis; Rodrigo-Gisbert, Marc; Vilaseca, Andreu; Hernandez Gonzalez, Manuel; Martinez Gallo, Monica; Alpuente, Alicia; Torres-Ferrus, Marta; Pujol Borrell, Ricard; Alvarez-Sabin, Jose; Pozo-Rosich, Patricia

Objective To define headache characteristics and evolution in relation to COVID-19 and its inflammatory response. Methods This is a prospective study, comparing clinical data and inflammatory biomarkers of COVID-19 patients with and without headache, recruited at the Emergency Room. We compared baseline with 6-week follow-up to evaluate disease evolution. Results Of 130 patients, 74.6% (97/130) had headache. In all, 24.7% (24/97) of patients had severe pain with migraine-like features. Patients with headache had more anosmia/ageusia (54.6% vs. 18.2%; p < 0.0001). Clinical duration of COVID-19 was shorter in the headache group (23.9 +/- 11.6 vs. 31.2 +/- 12.0 days; p = 0.028). In the headache group, IL-6 levels were lower at the ER (22.9 (57.5) vs. 57.0 (78.6) pg/mL; p = 0.036) and more stable during hospitalisation. After 6 weeks, of 74 followed-up patients with headache, 37.8% (28/74) had ongoing headache. Of these, 50% (14/28) had no previous headache history. Headache was the prodromal symptom of COVID-19 in 21.4% (6/28) of patients with persistent headache (p = 0.010). Conclusions Headache associated with COVID-19 is a frequent symptom, predictive of a shorter COVID-19 clinical course. Disabling headache can persist after COVID-19 resolution. Pathophysiologically, its migraine-like features may reflect an activation of the trigeminovascular system by inflammation or direct involvement of SARS-CoV-2, a hypothesis supported by concomitant anosmia.

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