Point of Care Diagnostic Test Kits – HIV Rapid Test Kits

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Description

GENERAL FEATURES

Product Description HIV Rapid Test Kit
Clinical Purpose To provide diagnosis of HIV infection

PRODUCT INFORMATION

Detects HIV 1 Antibodies,HIV 2 Antibodies
The assay should have solid phase/ particles coated HIV 1 and 2 recombinant and/or synthetic peptide antigens Yes
Test can be performed on Whole Blood
Type of Test Quantitative
Testing Principle Immuno Chromatographic
Result Time (minutes) 10-20
Ability to Evaluate Negative or Positive test result Yes
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 correctly Yes
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)” technology Yes
Storage temperature 2°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 WHO Yes
The kit should comply with all provisions of Drugs and cosmentics Act, 1940 and applicable rules there under Yes

KIT CONTENTS

Main items in test kit for performing the test Card
Sample Dropper Provided with each card/device Yes
Dessicant to absorb moisture so that the card do not get spoiled provided with each card Yes
Sample Diluent/Assay Buffer Provided Yes
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 kit Yes
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 kit Yes
Other accessories and spares provided if any for standard pack in the kit NA

PACKAGING

Pack Size 50 Tests Pack
The packing and labelling should be as per Drugs and Cosmetics Act, 1940 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 provision to conduct single test at a time Yes
Each test kit should be individually packed in a hermetically sealed and non-permeable pouch Yes

CERTIFICATIONS & REPORTS

The kit should have approval of the statutory authority in its country of origin Yes
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 Yes
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 Number FDA/LKO-20 B 840/015
Drug License Date 30/06/15
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) GMP
GMP/ WHO GMP Certification Number 13485
GMP/ WHO GMP Certification Date 17/02/2017
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 certified 3028
Certificatiion Number MAH/C-3028/C2
Certificatiion Date 30/9/18
Certification Issuing Authority NIMBUS
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 body Any other govt approved lab
Name of the Performance Evaluation Report issuing body if other than specified institute NA

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 consignee Yes

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