Bids Are Invited For Price Registration For Purchasing Rapid Tests For Municipal Ubss.

Rapid Test For Detection Of Influenza Virus A And B (Including H1n1): Immunochromatography For The Qualitative And Differential Detection Of Nucleoprotein Antigens Of Influenza Virus Type A (Including H1n1 And H3n2) And Influenza Virus Type B, In Nasopharyngeal Swab Samples. Detection Principle: Lateral Flow Immunochromatography (Rapid Method), Designed For Qualitative And Differential Detection Of Influenza A And Influenza B Antigens. Sample: Must Be Used With Nasopharyngeal Swab Or Nasal Swab Samples. The Kit Must Contain The Specific Sterile Swab For Collection. Minimum Sensitivity: The Test Must Present Validated Sensitivity And Specificity That Are Higher Than The Minimum Limits Required By International Regulatory Agencies And Anvisa For The Detection Of Both Strains. Differentiation: The Test Device Must Be Capable Of Showing Separate And Distinct Results For Influenza A And Influenza B In The Same Reading Window (Example: Test Line A And Test Line B). Result Time: Reading Time And Result Within A Maximum Of 20 (Twenty) Minutes After Application Of The Processed Sample. Presentation Of The Kit: Each Kit Must Contain All The Necessary Supplies To Carry Out The Test, Including: 1. Test Cassette (Individually Packed); 2. Sterile Collection Swab (The Type Must Be Suitable For Pediatric And Adult Use); 3. Extraction Tube With Buffer Solution; 4. Dropper Nozzle For Extraction Tube; 5. Leaflet/Instructions For Use In Portuguese. Registration And Regulation: The Product Must Have An Active And Valid Registration With Anvisa (National Health Surveillance Agency) And Fully Comply With Good Manufacturing Practices (Gmp). The Registration Number Must Be Informed At The Time Of The Proposal. Storage Conditions: The Test Must Be Able To Be Stored At Room Temperature Or Refrigerated (As Indicated On The Leaflet), Compatible With The Logistics Of Distribution In Basic Health Units. Validity On Delivery: The Product Must Be Delivered With A Remaining Expiration Date, Rapid Pregnancy Test: Single-Step Immunochromatography For The Qualitative Determination Of Chorionic Gonadotropin (Hcg) In Urine And/Or Serum Samples. Technical Requirement Minimum Required Specification Detection Principle: Lateral Flow Immunochromatography (Rapid Method), For Qualitative Detection Of The Beta-Hcg Fraction. Sample: Must Allow The Use Of Urine And/Or Serum/Plasma Samples. (Note: Preferably Urine For Primary Care Use.) Minimum Sensitivityminimum Sensitivity Of 25 Mui/Ml (Milli International Units Per Milliliter) Of Beta-Hcg. Accuracylevel Of Accuracy Declared By The Manufacturer Greater Than 99% (Sensitivity And Specificity). Result Time Reading Time And Result Within A Maximum Of 15 (Fifteen) Minutes After Applying The Sample. Kit Presentation Each Kit (Individually Packed) Must Contain, At A Minimum: 1. Device/Test Cassette (Individually Packed With Desiccant); 2. Dropper (Or Pipette) For Collecting And Applying The Sample; 3. Leaflet/Instructions For Use In Portuguese. Registration And Regulation The Product Must Have An Active And Valid Registration With Anvisa (National Health Surveillance Agency) And Fully Comply With Good Manufacturing Practices (Gmp). The Registration Number Must Be Informed At The Time Of The Proposal. Packaging Tamper-Proof Packaging, Containing Clear Product Identification Data, Batch, Expiration Date And Storage Conditions

2,74,927 - BRL

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