Point of Care Diagnostic Test Kit – Malaria Rapid Test Kits

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Description

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 (HRP-2/ LDH) and Pan Plasmodia against P.falciparum, P.vivax, P.ovale, P.malariae (LDH) from human serum or plasma or whole blood
Testing Method Lateral flow chromatographic immunoassay
Type of Test Quantitative
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) 20-30
Ability to Evaluate Negative or Positive test result Yes
Sensitivity (%) 100
Specificity (%) 100
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, 1940 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
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) Yes
Individualy 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 MALARIA AG P.F PAN

PACKAGING

Pack Size 30 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 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 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) NA for Domestically manufactured kit
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, 1940 (Proof of the same to be submitted to buyer on demand) For sale or distribution
Drug License Number BPT-13541/13542
Drug License Date 02/08/2016
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand) GMP
GMP/ WHO GMP Certification Number 29/MISC/03/2018-DC(59)
GMP/ WHO GMP Certification Date 08/08/2018
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 2400
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 institutes WHO

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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