Point of Care Diagnostic Test Kits – HIV Rapid Test Kits

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Description

GENERAL FEATURES

Product DescriptionHIV Rapid Test Kit
Clinical PurposeTo provide diagnosis of HIV infection

PRODUCT INFORMATION

DetectsHIV 1 Antibodies,HIV 2 Antibodies
The assay should have solid phase/ particles coated HIV 1 and 2 recombinant and/or synthetic peptide antigensYes
Test can be performed onWhole Blood
Type of TestQuantitative
Testing PrincipleImmuno Chromatographic
Result Time (minutes)10-20
Ability to Evaluate Negative or Positive test resultYes
The Assay should have sensitivity of > 99 point 5% and specificity of > 98%Yes
Contains an internal control band/dot for the confirmation that the test has been performed correctlyYes
The control dot/band should be able to detect the presence of human immunoglobulins and should not be just a “procedural control” or meant for merely checking the flow or reagents or integrity of the antigen except in kits using “lateral flow (Immunocytoflow) or flow through (Immunoconcentration)” technologyYes
Storage temperature2°C to 8°C
The supplier should ensure maintenance of recommended temperature during storage and transportation of Kits The Cumulative time temperature indicator technology used should be pre qualified by WHOYes
The kit should comply with all provisions of Drugs and cosmentics Act, 1940 and applicable rules there underYes

KIT CONTENTS

Main items in test kit for performing the testCard
Sample Dropper Provided with each card/deviceYes
Dessicant to absorb moisture so that the card do not get spoiled provided with each cardYes
Sample Diluent/Assay Buffer ProvidedYes
Packaging insert in English detailing the principle, components, details of antigen for antibody detection of HIV 1 and 2, methodologies, validity criteria, performance characteristics,bio-safety, limitations of assay, storage condition, manufacturing and expiry dates and methods of disposal provided with each kitYes
Provided with HIV positive and negative serum controls sufficient for conducting 20% of the tests (10 % negative and 10 % positive controls)Yes
Individually packed sterile disposable lancets and disposable alcohol swabs provided with each test kitYes
Other accessories and spares provided if any for standard pack in the kitNA

PACKAGING

Pack Size50 Tests Pack
The packing and labelling should be as per Drugs and Cosmetics Act, 1940 and applicable rules there underYes
Each card (cassette) should have space for patients particulars and date of the testYes
The test kit should be packed in such a way that there is provision to conduct single test at a timeYes
Each test kit should be individually packed in a hermetically sealed and non-permeable pouchYes

CERTIFICATIONS & REPORTS

The kit should have approval of the statutory authority in its country of originYes
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 1940Yes
Availability of valid drug license from competent authority defined under Drugs and Cosmetics Act, 1940 (Proof of the same to be submitted to buyer on demand)For sale or distribution
Drug License NumberFDA/LKO-20 B 840/015
Drug License Date30/06/15
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand)GMP
GMP/ WHO GMP Certification Number13485
GMP/ WHO GMP Certification Date17/02/2017
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 certified3028
Certificatiion NumberMAH/C-3028/C2
Certificatiion Date30/9/18
Certification Issuing AuthorityNIMBUS
Availability of Test report from Central GOVT/NABL/ILAC accredited Lab to prove the conformity to the declared specification( proof of the same to be submitted to the buyer on demand)Yes
Availability of Performance Evaluation Report (Proof of the same to be submitted to the buyer on demand)Yes
Performance Evaluation Report issuing bodyAny other govt approved lab
Name of the Performance Evaluation Report issuing body if other than specified instituteNA

SHELF LIFE

Shelf Life (in months)24
The product should not have passed more than 1/6 of the total shelf life at the time of dispatch to the consigneeYes

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