RequiredExperience with Government
RequiredCertificate (Requested in ATC)
RequiredOEM Authorization Certificate Bid to RA enabled No Point Of Care Diagnostic Test Kit - Malaria Rapid Test Kits ( 13325 pieces ) Technical Specifications * As per GeM Category Specification Specification Specification Name Values Bid Requirement (Allowed Values) GENERAL FEATURES Product Description Malaria Rapid Test Kit * Clinical Purpose To provide early diagnosis of Malaria infection * PRODUCT INFORMATION Test differentially detects Antigen of P.Falciparum (Pf) and P.vivax (Pv) Antigen of P.Falciparum (Pf) and P.vivax (Pv) 1/6 from human serum or plasma or whole blood from human serum or plasma or whole blood Testing Method Lateral flow chromatographic immunoassay * Type of Test Qualitative Qualitative The test should be based on the principle of capture of parasite antigen from blood using monoclonal antibodies specific for antigen target Yes * Result Time (min) 10-20 * Ability to Evaluate Negative or Positive test result Yes * Sensitivity (%) - * Specificity (%) - * Contains an internal control line for the confirmation that the test has been performed correctly Yes * Storage temperature 2°C to 30°C * The supplier should ensure maintenance of recommended temperature during storage and transportation of Kit Yes * The kit should comply with all provisions of Drugs and cosmentics Act
Required1940 and applicable rules there under Yes * KIT CONTENTS Main item in test kit for performing the test Card * Sample Dropper Provided with each card Yes * Dessicant to absorb moisture so that the Card do not get spoiled provided with each card Yes * Sample Diluent/Assay Buffer Provided Yes * 2/6 Packaging insert in English detailing the principle
Requiredcomponents
Requiredmethodologies
Requiredvalidity criteria
Requiredperformance c haracteristics
Requiredbio- safety
Requiredlimitations of assay
Requiredstorage condition
Requiredmanufacturing and expiry dates and methods of disposal Provided with each kit Yes * Reactive and non reactive controls provided with each kit in adequate volume (minimum 10% of pack size) No No Individualy packed sterile disposable lancets and disposable alcohol swabs provided with each test kit Yes Yes
RequiredNo Other accessories and spares provided if any for standard pack in the kit - * PACKAGING Pack Size 25 Tests pack 25 Tests pack The packing and labelling should be as per Drugs and Cosmetics Act
Required1940 and applicable rules there under Yes * Each card (cassette) should have space for patients particulars and date of the test Yes * The test kit should be packed in such a way that there is proivision to conduct single test at a time Yes * Each test kit should be indivdually packed in a hermetically sealed and non-permeable pouch Yes * CERTIFICATIONS & REPORTS The kit should have approval of the Yes * 3/6 statutory authority in its country of origin The Kit should be registered and licensed in India by DCGI in case of imported kits (Proof of the same to be submitted to buyer on demand) Yes * Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940 NA for imported kits * Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act
Required1940 (Proof of the same to be submitted to buyer on demand) For Manufacture to sale
RequiredFor sale or distribution * Drug License Number - * Drug License Date - * Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) GMP
RequiredWHO GMP * GMP/WHO GMP Certification Number - * GMP/WHO GMP Certification Date - * ISO 13485 Certified Manufacturer (Proof of the same to be submitted to buyer on demand) Yes * Product Certifications (Proof of the same to be submitted to buyer on demand) EU-CE (IVD) * Four digit number of notified body If product is EU-CE certified - * Availability of Test report from Central GOVT/NABL/ILAC accredited Lab to prove Yes * 4/6 the conformity to the declared specification( proof of the same to be submitted to the buyer on demand) Availability of Performance Evaluation Report (Proof of the same to be submitted to the buyer on demand) Yes * Performance Evaluation Report issuing body National Insitute of Biological Sciences
RequiredNational Institute of Malaria Research (ICMR)
RequiredAny other govt approved lab * Name of the Performance Evaluation Report issuing body if other than specified institutes - * SHELF LIFE Shelf Life (in months) 24 24 The product should not have passed more than 1/6 of the total shelf life at the time of dispatch to the consignee Yes * * Specifications highlighted in bold are the Golden Parameters. * Bidders may note that In respect of non-golden Parameters
Requiredthe specifications 'Values' chosen by Buyer will generally be preferred over 'Bid requirement ( allowed Values) by the Buyer.
