Point of care Diagnostic Test Kit- Chikungunya Rapid Test kit

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Description

GENERAL FEATURES

Product Description Chikunguny Rapid Test Kit
Clinical Purpose To detect antibodies to Chikungunya in human serum or plasma
Detects IgM Antibodies to Chikungunya,IgG Antibodies to Chikungunya
Type of Test Qualitative
Testing Principle Immuno-chromatographic Principle
Specimen Required for testing Serum,Plasma
Result Time (min) 15-20
Ability to Evaluate Negative or Positive test result Yes
Sensitivity (%) 93.55
Specificity (%) 100
Contains an internal control line for the confirmation that the test has been performed correctly Yes
Storage temperature 2 degree C to 30 degree 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 cosmetics Act, 1940 and Rules, 1945 Yes

KIT CONTENTS

Main items in test kit for performing the test Card
Sample Dropper Provided with each card Yes
Sample Diluent/Assay Buffer Provided Yes
Dessicant to absorb moisture so that the Card do not get spoiled Yes
Packaging insert in English detailing the principle, components, 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
Reactive and non reactive controls provided with each kit in adequate volume (minimum 10% of pack size) No
Clean, dry sterilized sample collection container present with the kit Yes
Other accessories and spares provided if any for standard pack in the kit STANDARD MATERIAL

PACKAGING

Pack Size 25 Tests pack
The packing and labelling should be as per Drugs and Cosmetics Act, 1940 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 moisture proof pouches Yes
Test Kit container for housing all the items in the kit 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 (Proof of the same to be submitted to buyer on demand) 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 Manufacturing
Drug License Number N(1094)15W
Drug License Date 05.11.2015
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) GMP
GMP/WHO GMP Certification Number GMP W-0052-14-MB-MFG-DC-1907
GMP/WHO GMP Certification Date 28-06-2017
ISO 13485 Certified Manufacturer (Proof of the same to be submitted to buyer on demand if Certification is available) Yes
Product Certifications (Proof of the same to be submitted to buyer on demand) EU-CE
Four digit number of notified body If product is EU-CE certified 1804
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 National Institute of Biological Sciences MFG QC Lab , CP LABS

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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