OEM One Step Government Lateral Flow Test Kits 90% Specificity

Rapid Test Kit Rapid Antigen Test SARS-CoV-2 Antigen & Influenza A/B Rapid Test

Intended Use

The SARS-CoV-2 Antigen & Influenza A/B Rapid Test Kit

(Immunochromatography) is a lateral flow chromatography immunoassay intended for the 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. It is for professional use only. It is an aid in the diagnosis of the patients with suspected SARS-CoV-2 or influenza infection in conjunction with clinical presentation and results of other laboratory tests. Results from this test kit should not be used as the sole basis for diagnosis.

Negative results should be treated as presumptive and confirmed by viral culture or a molecular assay. Negative results do not rule out COVID-19 and influenza virus infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. The kit is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings. For prescription use only. For in vitro diagnostic use only.

Specification

Main Components

• Test cassettes
• Sample extraction
• Sample tubes
• Swabs
• Tube Stand
• Instruction Manual

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

• Advanced technological influenza virus testing kit based on immunochromatography assay
• One-step test that easiky performed in emergency department, clinic department, community hospitals etc.
• Result output within 15 minutes

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.