ISO 13485 Professional Influenza AB Test Kit Flu Swab Antigen Kit

Rapid Test Kit CoV-19 And Influenza A/B Rapid Test Kit Professional Use 20 Tests High Quality 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

Performance Characteristics

Main Components

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

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

• High Accuracy, Specificity and Sensitivity
• QUICK CHECK, Easy to use in simple step,
• Fast Recation, 15 minutes out of results.

Other Informations

• This reagent is a qualitative detection reagent, which cannot determine the exact content of antigen.
• False negative results may be caused by unreasonable sample collection, transport and treatment, and low viral load in samples.
• For IN VITRO diagnostic use only
• Reagents should be used as soon as possible after opened. This reagent cannot be reused for disposable.
• The test device should remain in the sealed pouches until use. If sealing problem happens, do not test. Don’t use after the expiration date.

FAQ

• MOQ

We have the MOQ limit, which is 10000 pices.

• Delivery date

About 1 week include export application, commodity inspection, customs clearance and air flight, all are necessary processes for China test kits.

• Register the products in my country

Sure, we will provide all you documents and samples you need for register.

• Lead time

Usually 1-7 days, since it was produced against specific demands to guarantee most freshness.

• Shipment

We choose Air cargo or Ocean cargo and International EXPRESS(DHL).

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.