Product description Specimen Format Kit Specifications

AbChek COVID-19 (SARS-CoV-2) Antigen Rapid Test Nasopharyngeal Cassette 25 Tests/kit

swab
1. Introduction:

Corona viruses are enveloped RNA viruses that are distributed broadly among humans, birds and
other mammals, that cause respiratory, enteric, hepatic, and neurologic diseases. Six corona virus
species are known to cause human disease. 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.
Novel corona virus pneumonia, is short for NP, its pathogen is the novel corona virus. WHO has
officially named the disease as corona virus diseases 2019 (COVID-19).

2. Intended Use:

AbChek CoVID-19 Antigen test is a rapid and convenient immuno chromatographic assay for the
qualitative detection of COVID-19 antigen (viral nucleoprotein) from nasopharyngeal swab obtained
from patient with signs and symptoms of respiratory infection.

The device is designed to aid in the rapid differential diagnosis of COVID-19 Virus infection. This
assay is not intended to be used for screening patients or as an aid for diagnosis of patients with
suspected COVID-19 Ag infection, this assay is not intended for home testing (or self-testing).The
test results should be confirmed by Real-Time Reverse Transcriptase (RT-PCR Diagnostic kit: they do
not preclude COVID-19 Virus infection and should not be used as the sole basis for treatment or
other management decisions. The test is intended for professional and laboratory use.

3. Specifications:

 Specimen: Nasopharyngeal swab

 Shelf life and storage temperature: 24 months at 4-30 °C
 Performance Characteristics:

 Diagnostic Sensitivity: 96.7%

 Diagnostic Specificity: 100%

 Results interpretation time: 15 Minutes

 No cross-reactivity was observed when tested with; Adenovirus, Influenza A, Influenza B,

Respiratory syncytial virus, Coronavirus OC43, Legionella Pneumophila, Streptococcus
pneumonia, Mycoplasma Pneumoniae, Human Metapneumovirus (hMPV), Hepatitis C Virus,
Hepatitis B Virus, HPV and HIV

 No interference was observed, when tested with the below interfering samples;
Respiratory specimens: Mucin: Bovine sub-maxillary gland, type I-S, Blood (Human), EDTA anti-
coagulated and Biotin
Nasal Sprays or drops: Neo-Synephrine, Phenylephrine, Afrin Nasal Spray, Oxymetazoline, Saline
Nasal Spray
Homeopathic allergy relief medicine: Homeopathic Zicam Allergy Relief Nasal Gel, Sodium
Cromoglycate, Olopatadine Hydrochloride

Page 1 of 2
Anti-Viral drugs: Zanamivir (Influenza), Oseltamivir (Influenza), Artemether-lumefantrine
(Malaria), Doxycycline hyclate (Malaria), Quinine (Malaria), Lamivudine (Retroviral medication),
Ribavirin (HCV), Daclatasvir (HCV)
Anti-Inflammatory medication: Acetaminophen, Acetylsalicylic acid, Ibuprofen
Antibody: Mupirocin, Tobramycin, Erythromycin, Ciprofloxacin

Page 2 of 2