Point of Care Diagnostic Test Kit – Malaria Rapid Test Kits

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Description

GENERAL FEATURES

Product DescriptionMalaria Rapid Test Kit
Clinical PurposeTo provide early diagnosis of Malaria infection

PRODUCT INFORMATION

Test differentially detectsAntigen 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 MethodLateral flow chromatographic immunoassay
Type of TestQuantitative
The test should be based on the principle of capture of parasite antigen from blood using monoclonal antibodies specific for antigen targetYes
Result Time (min)20-30
Ability to Evaluate Negative or Positive test resultYes
Sensitivity (%)100
Specificity (%)100
Contains an internal control line for the confirmation that the test has been performed correctlyYes
Storage temperature2°C to 30°C
The supplier should ensure maintenance of recommended temperature during storage and transportation of KitYes
The kit should comply with all provisions of Drugs and cosmentics Act, 1940 and applicable rules there underYes

KIT CONTENTS

Main item in test kit for performing the testCard
Sample Dropper Provided with each cardYes
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, methodologies, validity criteria, performance characteristics,bio-safety, limitations of assay, storage condition, manufacturing and expiry dates and methods of disposal Provided with each kitYes
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 kitYes
Other accessories and spares provided if any for standard pack in the kitMALARIA AG P.F PAN

PACKAGING

Pack Size30 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 proivision to conduct single test at a timeYes
Each test kit should be indivdually 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)NA for Domestically manufactured kit
Indigenous manufacturers should be licensed by the competent authority defined under Drugs and Cosmetics act 1940NA 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 NumberBPT-13541/13542
Drug License Date02/08/2016
Manufacturer certifications (Proof of the same to be submitted to the buyer on demand)GMP
GMP/ WHO GMP Certification Number29/MISC/03/2018-DC(59)
GMP/ WHO GMP Certification Date08/08/2018
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 certified2400
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 institutesWHO

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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