Quick Immunoassay
ACCO COVID-19 Ag
Rapid immunoassay for COVID-19 infection

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) which is an enveloped non-segmented positive-sense RNA virus, is the cause of coronavirus disease (COVID-19). SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M), and nucleocapsid (N). The antigen is generally detectable in upper respiratory samples during the acute phase of infection.

AccoBiotech’s SARS-CoV-2 Antigen Rapid Test Kit is an immunochromatographic assays which designed to detect the presence or absence of SARS-CoV-2 nucleocapsid proteins in respiratory samples from patients with signs and symptoms of SARS-CoV-2 infection. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibodies bound on the membrane. A color band will show up when antigen-conjugate is deposited at the Test “T” position and the Control “C” position on the device.

1. Analytical sensitivity/cross-reactivity

• Detection limit (LoD): 2.87 x 103 TCID50/ml (heat-inactivated culture fluid).

•Cross-reactivity: There was cross-reactivity of SARS CoV-1. However, there were no cross-reactivities of MERS coronavirus, Human coronavirus (NL63), Human coronavirus (229E), Human coronavirus (OC43), Human Adenovirus type 1, Human Adenovirus type 3, Human Adenovirus type 8, Human Adenovirus type 18, Human Adenovirus type 23, Human Adenovirus type 7, Human Adenovirus type 5, Human Adenovirus type 11, Human Parainfluenza virus type 1, Human Parainfluenza virus type 2, Human Parainfluenza virus type 3, Human Parainfluenza virus type 4, Human Rhinovirus type 1, Human Rhinovirus type 14, Human Rhinovirus type 42, Human Metapneumo virus, Respiratory syncytial virus-A, Respiratory syncytial virus-B.

2. No Interference

• Not interfered for Whole blood, Mouth wash, Phenylephrine, Acetylsalicylic acid, Beclomethasone, Benzocaine, Flunisolide, Guaiacol glyceryl ether, Menthol, Oxymetazoline, Tobramycin, Zanamivir, Oseltamivir phosphate, mucous.

3. Prozone effect (Hook effect)

• No prozone effect at 1.15 x 107 TCID50/ml or at 1,000 ug/ml of nucleoprotein of SARS-CoV-2.

References

1. Li Guo, et al. (2020) Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease. Clinical Infectious Diseases, ciaa310, DOI: 10.1093/cid/ciaa310.
2. Wei Zhang, et al. (2020) Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerging Microbes & Infections, 9:1, 386-389, DOI: 10.1080/22221751.2020.1729071.
3. Ning Wang, et al. (2018) Serological Evidence of Bat SARS-Related Coronavirus Infection in Humans, China. Virologica Sinica 33:104–107, DOI: 10.1007/s12250-018-0012-7.
4. Zhengtu Li, et al. (2020) Development and Clinical Application of A Rapid IgM-IgG Combined Antibody Test for SARS-CoV-2 Infection Diagnosis. Journal of Medical Virology, DOI: 10.1002/jmv.25727.
5. Peng Zhou, et al. (2020) Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin. Nature DOI: 10.1038/s41586-020-2012-7.