Clungene – SARS-CoV-2 Ag, saliva (1/box)

Studies have reported no statistically significant difference in viral load between nasopharyngeal or oropharyngeal swabs and saliva samples. On this basis, Clungene developed a rapid antigen test that uses saliva.

The COVID-19 antigen rapid test is a lateral-flow immunoassay intended for the qualitative detection of SARS-CoV-2 in saliva. Because sampling is non-invasive, it is recommended for testing children.

• Rapid results: 10–15 minutes
• Sensitivity 97.5%, specificity 100% — evaluated against RT-PCR
• Simple, quick and inexpensive procedure that supports a fast clinical decision
• No additional reagents or further processing; visual reading of the result, suited to patient screening
• Does not require highly specialised staff
• Shelf life: 24 months; storage between 4°C and 30°C

Box contents: 1 test cassette, 1 extraction reagent (vial with 0.3 mL), 1 saliva collector, 1 extraction tube, 1 dropper tip, 1 package insert.

Cross-reactivity was evaluated against 32 commensal and pathogenic micro-organisms that may be present in the oral cavity. No cross-reactivity was observed with recombinant MERS-CoV NP protein (50 μg/mL), with Influenza A (H1N1, H1N1pdm09, H3N2), Influenza B (Yamagata, Victoria), Adenovirus (types 1, 2, 3, 5, 7, 55), human metapneumovirus, Parainfluenza (types 1–4), respiratory syncytial virus, Enterovirus, Rhinovirus, human coronaviruses 229E, OC43, NL63 and HKU1 (1.0 × 10⁶ PFU/mL), nor with Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (group A), Streptococcus pneumoniae, Candida albicans or Staphylococcus aureus (1.0 × 10⁷ CFU/mL).