Rapid Antigen And Influenza Rapid Test Kit SARS-CoV-2 Antgen And Influenza A/B Rapid Test High Specificity Rapid Test Kit

Intended Use
The rapid test kit is intended for qualitative detection and differentiation of nucleocapsid protein antigens from SARS-CoV-2, influenza type A and influenza type B in the same time directly from nasal/nasopharyngeal (NS/NP) swab, oropharyngeal (OP) swab and saliva specimens from patients with signs and symptoms of respiratory viral infection. The test kit is for professional use only.
Specification

Main Components

• 20 Test cassettes
• 2 Sample extraction buffers
• 20 Sample tubes
• 20 Swabs
• 1 Tube Stand
• 1 Package Insert

Sample Treatment

Add 550μl sample extraction(about 22-24 drops) into the sample tube, dip the swab after collecting the sample into the sample extraction liquid, fully immerse the tip of the swab, rotate and squeeze the swab 10 times, then pull out the swab, and take the stranded liquid as the sample to test cassette.

Use Step

• Take out the test cassette from the sealed pouch, place it on a clean and level surface with the sample port well up.

• Apply 2 full drops of the treated sample (60μl-70μl) vertically into each of the two sample wells of the test cassette.

• Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

Interpretation Of Result

• POSITIVE: The presence of T (T on nCoV /A or B on Flu) and C lines within the reaction window indicate a positive result on SARS-CoV-2 or Flu A and/or B infection or co-infection.

• NEGATIVE: One colored line appears in the control region(C). No apparent colored line appears in the test region (T on nCoV /A or B on Flu). The negative result does not indicate the absence of analytes in the sample, it only indicates the level of tested analytes in the sample is less than the minimum detection limit

• INVALID: No colored lines appear, or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

Feature

• Short test time, 15 minutes read the result
• Easy operation, one step solution
• Lower cost with high effciency

Cross-reactivity

• Cross reactivity of the SARS-CoV-2 test strip:

With human coronavirus 229E, human coronavirus OC43, human coronavirus NL63, adenovirus, human metapneumovirus, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, influenza A, type B Influenza, enterovirus, respiratory syncytial virus, rhinovirus, SARS coronavirus, MERS coronavirus, Haemophilus influenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Candida albicans, Bordetella pertussis, Mycoplasma pneumonia, pneumonia Chlamydia, Legionella pneumophila, etc. have no cross reaction.

• Cross reactivity of the Influenza A/B test strip:

With respiratory Syncytial Virus A, measles Virus, Mumps Virus , adenovirus Type 3, parainfluenza Type 2 , partial Pulmonary Virus, human coronavirus OC43, human coronavirus 229E, human herpes virus 6, cytomegalovirus, epstein Barr Virus, enterovirus CA16, rhinovirus, staphylococcus aureus, streptococcus pneumoniae, mycoplasma pneumoniae, parapertussis, chlamydia pneumoniae, escherichia coli, pooled human nasal wash, candida albicans, etc. have no cross reaction.

Labnovation Technologies, Inc. is an original manufacturer established in Shenzhen, China since 2001. We are dedicated in developing and manufacturing IVD instruments and reagents including HbA1c analyzer and reagents, rapid test reader & reagents, hematology reagents, clinical chemistry reagents, electrolyte reagents, wash solution and urine test reagents.
 

Labnovation products are developed in house, tested extensively in clinics and passed strict quality controls. All of our products are CE marked and approved by SFDA. In the past 15 years, our products have been exported to 110 different countries and used in 8000 hospitals worldwide. We provide both ready-to-use final products and bulk OEM reagents, including ready-to-use reagents, concentrated, and powder.

With an investment of 10% of our annual sales into R&D, we release new products every years. We win more and more domestic and international cooperation by company reputation and products quality while we actively take part in fairs like MEDICA,AACC, ARBA HEALTH and so on through which we are well-known by the companies in this field.