Request For Quotation Laboratory Reagents For Prenatal Screening

Calibrator. The Calibrator For The Free Beta Subunit Of Human Chorionic Gonadotropin Should Be Used To Correct The Standard Curve Stored In B·R·A·H·M·S Kryptor Compact Plus. The Calibrator Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Package Should Consist Of: Ready-To-Use Highly Purified Free Β-Hcg, Serum Of Newborn Calves And Preservatives; The Sticker With The Barcode Must Contain Information About The Batch Of The Calibrator, Including The Concentration Value. The Number Of Bottles In The Package Should Be 6; The Stability Of The Calibration Must Be At Least 15 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2023; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate In The Ministry Of Health Of The Republic Of Kazakhstan. Application, A Set Of Reagents For Determining The Free Beta Subunit Of Human Chorionic Gonadotropin Should Quantitatively Determine The Concentration Of Free Β-Hcg (Free Beta Subunit Of Human Chorionic Gonadotropin) In Human Blood Serum. The Set Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Kit Should Consist Of: Ready-To-Use Xl-Conjugate Containing Monoclonal Antibody To Free Β-Hcg Conjugated With Xl-665, Buffer, Bovine Albumin, Non-Specific Mouse Immunoglobulins, Potassium Fluoride; Ready-To-Use K-Conjugate Containing A Monoclonal Antibody To Free Β-Hcg Conjugated With Europium Cryptate, Buffer, Bovine Albumin, Mouse Nonspecific Immunoglobulins, Potassium Fluoride; Ready-To-Use Diluent Containing The Serum Of Newborn Calves, Preservatives: The Set Must Have A Sticker With A Barcode Containing All The Information Necessary For The Registration Of A New Batch Of Reagents; The Number Of Tests In The Set Should Be 75; Sample Type - Serum; The Volume Of The Sample Required For The Analysis Should Be At Least 26 Μl; Incubation Time Should Be No More Than 19 Minutes; The Results Must Be Presented In Ng/Ml; The Stability Of The Set In The Analyzer (Stability After Opening) Must Be No Less Than 29 Days; A Set Of Reagents For Determining The Free Beta Subunit Of Human Chorionic Gonadotropin. The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2023; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, A Set Of Reagents For The Determination Of Plasma Protein A Associated With Pregnancy. A Set Of Reagents For The Quantitative Determination Of The Determination Of Pregnancy-Associated Protein A Plasma Should Quantitatively Determine The Concentration Of Papp-A (Pregnancy-Associated Protein-A Plasma) In Human Serum. The Set Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Kit Should Consist Of: Ready-To-Use Xl-Conjugate Containing Monoclonal Antibody To Papp-A Conjugated With Xl665, Buffer, Bovine Albumin, Non-Specific Mouse Immunoglobulin And Potassium Fluoride.; Ready-To-Use K-Conjugate Containing A Monoclonal Antibody To Papp-A Conjugated With Europium Cryptate, Buffer, Bovine Albumin, Mouse Nonspecific Immunoglobulins, Potassium Fluoride; Ready-To-Use Diluent Containing Newborn Calf Serum, Sodium Azide, Preservatives: The Set Must Have A Sticker With A Barcode Containing All The Information Necessary For Registering A New Batch Of Reagents; The Number Of Tests In The Set Should Be 75; Sample Type - Serum; The Volume Of The Sample Required For The Analysis Should Be At Least 50 Μl; Incubation Time Should Be No More Than 19 Minutes; The Results Must Be Presented In Mu/L; The Stability Of The Set In The Analyzer (Stability After Opening) Must Be No Less Than 29 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2023; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate In The Ministry Of Health Of The Republic Of Kazakhstan., Calibrator. The Calibrator For Plasma Pregnancy-Related Protein A Should Be Used To Correct The Standard Curve Stored In B·R·A·H·M·S Kryptor Compact Plus. The Calibrator Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory. The Package Should Consist Of: Papp-A/Prombp Complex Of Human Origin, Human Blood Serum And Sodium Azide; The Sticker With The Barcode Must Contain Information About The Batch Of The Calibrator, Including The Concentration Value. The Number Of Bottles In The Package Should Be 6; The Stability Of The Calibration Must Be At Least 15 Days; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2023; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate In The Ministry Of Health Of The Republic Of Kazakhstan., Buffer. The Buffer Should Be A Concentrate Of Phosphate-Salt Buffer Solution (Pbs), Which Should Be Intended For The Preparation Of Systemic Fluid; The Buffer Must Be Compatible With The Automatic Biochemical Analyzer B•R•A•M•S Kryptor Compact Plus Installed In The Customers Laboratory; The Buffer Should Be In The Form Of A Powder; The Package Must Contain At Least 5 Sachets; Each Bag Must Be At Least 65 Grams; A Bag Of Powder Should Be Diluted In The Ratio Of 1 Bag To 5 Liters Of Distilled Water; The Composition Of The Powder Should Contain Potassium Phosphate In A Concentration Of At Least 25%, Sodium Phosphate In A Concentration Of At Least 50% And Sodium Chloride In A Concentration Of At Least 50%; Ph Should Be In The Range From 6.8 To 7.0; ; A Bag Of Powder Should Be Diluted In The Ratio Of 1 Bag To 5 Liters Of Distilled Water; The Buffer Solution Should Remain Stable For At Least 15 Days; The Storage Temperature Should Be No Less Than 18°C ​​And No More Than 30°C. The Product Release Date Must Be No Earlier Than 2023; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate With The Ministry Of Health Of The Republic Of Kazakhstan, Control. A Set Of Controls For Prenatal Screening Must Be Used To Control The Quality Of The Analysis In The B•R•A•M•S Kryptor Compact Plus Device Installed In The Customers Laboratory; The Package Must Have Three Levels Of Control, 2 Vials Per Level; Each Vial Should Contain A Lyophilized Mixture Of Such Human Antigens As Afp, Free Β-Hcg And Papp-A, Human Blood Serum And A Preservative; A Sticker With A Barcode Must Contain Information About The Batch Of Controls, In Particular, The Values ​​Of The Target Concentrations, The Obtained Values ​​Of The Standard Deviations, And The Acceptable Concentration Ranges; The Package Must Contain Self-Adhesive Labels With A Bar Code Of 32 For Each Control; The Number Of Bottles In The Package Should Be 6; The Principle Of Analysis Should Be A Sandwich Method; The Storage Temperature Should Be No Less Than 2°C And No More Than 8°C. The Product Release Date Must Be No Earlier Than 2023; The Supplier Provides Documents Confirming The Compliance Of The Supplied Goods With The Requirements Established By Technical Regulations, Provisions Of Standards Or Other Documents In Accordance With The Legislation Of The Republic Of Kazakhstan, Including A Registration Certificate In The Ministry Of Health Of The Republic Of Kazakhstan.