BIOCREDIT COVID-19 AG (CE IVD)

The New Rapid SARS-CoV-2 Antigen Test

More Sensitive then Antibody Detection

Respiratory and Tuberculosis Disease

BIO CREDIT COVID-19 AG


2019 novel coronavirus (2019-nCoV) is a single-stranded RNA coronavirus. Coronavirus disease 2019 (COVID-19) is a
respiratory illness caused by the 2019-nCoV. 2019-nCoV belongs to the Betacoronavirus Genus, which also includes
Severe Acute Respiratory Syndrome coronavirus (SARS-CoV, 2003) and Middle East Respiratory Syndrome
coronavirus (MERS-CoV, 2012).
Coronaviruses, 2019-nCoV consist of a four viral proteins named spike (S), envelope (E), membrane (M), and
nucleocapsid (N). Common signs of infection include respiratory symptoms, fever, cough, shortness of breath and
breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome,
kidney failure and even death.
Standard recommendations to prevent infection spread include regular hand washing, covering mouth and nose
when coughing and sneezing, thoroughly cooking meat and eggs. Avoid close contact with anyone showing
symptoms of respiratory illness such as coughing and sneezing.


Description
BIOCREDIT COVID-19 Ag is a lateral flow immunochromatographic assay that adopted dual colour system. For the
qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab specimen.
The test contains colloid gold conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-
2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible black band appears on the
test lines (T) as antibody-antigen-antibody gold conjugate complex forms.
The control line (C) is used for procedural control and should always appear if the test is performed correctly.
Evaluated with panel specimen (n = 75) by PCR
Sensitivity: 92 %
Specificity: 98 %
 The First commercialization Black Gold Particle Technology in the world (High Sensitivity and specificity).
 User friendly Dual Colour Systems (Control Line: Red, Test Line: Black)
 Rapid Tests Time (5 – 8 Min)
 Simple detection of SARS-CoV2 antigen
BIOCREDIT COVID-19 Ag Rapid Test Kit Package:
 Intended Use : Detection of SARS-CoV2 antigen
 Package : 20 Tests / Kit
 Storage : 1 - 40C
 Specimen Type : Nasopharynx / Nasopharyngeal
 Shelf Life : 24 months from the manufacture date
 Time to result : 5 – 8 minute

Type
Immunochromatography rapid test


Application
COVID-19, Nasopharyngeal swabs

Storage/Expiration
Store at 1-40℃. Shelf life is 12 months from the date of manufacture.


Calibration Range
Qualitative

 

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