3
MALARIA MALARIA re-emerging as world No.1 infectious Killer Malaria is the most common infectious tropical disease and an enormous public health problem. It is caused by the parasite called plasmodium and is passed to human by mosquito (female anopheles). It is a disease that can be treated in just 2 days, yet it can cause fatal complication if the . diagnosis is delayed Infection Sporozoites Liver Infected RBCs Merozoite Invasion Adhesion to endothelium Merozoites A sexual Cycle Gametocytes Transmission to mosquito WHO GMP CERTIFIED ANTIGEN TEST MADE MALARIAL DETECTION JUST EARLY, EASY & ACCURATE..... ADVANTAGE MAL CARD ADVANTAGE MALARIA PAN+Pf CARD ADVANTAGE Pf MALARIA CARD ADVANTAGE MALARIA CARD ADVANTAGE PAN MALARIA CARD

MALARIAMALARIAtheadcode.com/.../Catalogue-Malaria-All-Product.pdf · 2020-06-01 · MALARIAMALARIA re-emerging as world No.1 infectious Killer Malaria is the most common infectious

  • Upload
    others

  • View
    2

  • Download
    0

Embed Size (px)

Citation preview

Page 1: MALARIAMALARIAtheadcode.com/.../Catalogue-Malaria-All-Product.pdf · 2020-06-01 · MALARIAMALARIA re-emerging as world No.1 infectious Killer Malaria is the most common infectious

MALARIAMALARIAre-emerging as world No.1 infectious KillerMalaria is the most common infectious tropical disease and an enormous public

health problem. It is caused by the parasite called plasmodium and is passed

to human by mosquito (female anopheles). It is a disease that can be treated

in just 2 days, yet it can cause fatal complication if the .diagnosis is delayed

Infection

Sporozoites

Liver

Infected RBCs

Merozoite Invasion

Adhesion to endothelium

Merozoites

A sexualCycle

Gametocytes

Transmissionto mosquito

W H O G M P

CERT I F I ED

ANTIGEN TEST MADE MALARIAL DETECTION

JUST EARLY, EASY & ACCURATE.....

ADVANTAGE MAL CARD

ADVANTAGE MALARIA PAN+Pf CARD

ADVANTAGE Pf MALARIA CARD

ADVANTAGE MALARIA CARD

ADVANTAGE PAN MALARIA CARD

Page 2: MALARIAMALARIAtheadcode.com/.../Catalogue-Malaria-All-Product.pdf · 2020-06-01 · MALARIAMALARIA re-emerging as world No.1 infectious Killer Malaria is the most common infectious

Combining Reliability with Convenience through Rapid Antigen Test...

Lets know about J. Mitra Malaria principle.....

(1) Conjugated antibody (Ab),

specific for target antigen, is

present below the nitrocellulose

strip. Target Antigen specific

Antibody is bound to the strip in a

thin (test) line, and control

antibody, is bound at the control

line.

(2) Blood Sample containing

parasite antigen (HRP-2 and/or

pLDH) and Assay Buffer, are

added in the respective well, are

mixed with conjugated antibody

and are drawn up by capillary

action in the strip across the lines

of bound antibody.

(3 ) I f ant igen i s present ,

conjugated Ab-Ag complex will

be trapped on the test line. Excess

conjugated antibody is trapped

on the control line.

Depending on the target antigen

detect ion and dif ferent ial

detection of plasmodium species,

no. of test lines will vary.

Control band(bound Ab)*

Test line(bound Ab)*

Lysing agent &conjugated Ab

* Antibody bands are not normally visible

C TA B

Conjugated Ab(Free)

Bound Antibodyon membrane

(1)

Capturedconjugated Ab

Conjugated Ab-Agcomplex

C TA B

(3)

Conjugated Ab-Agcomplex captured by bound Ab of test band

Conjugated Abcaptured by boundAb of control band

AssayBuffer/flushingagent

Blood and conjugated Ab flushed along strip

Parasiteantigen (Ag)captured byconjugated Ab C T

A B

Parasitized Bloodcontaining antigen

HRP2 and/or pLDH

(2)

PLASMODIUM SPECIES DETECTION BY DIFFERENT TEST

Test Line PAN P.v Pf

Product Name HRP-2 pLDH

Advantage Mal Card

Advantage Malaria Pan+Pf Card

Advantage Pf Malaria Card

Advantage Malaria Card

Advantage Pan Malaria Card

TEST PROCEDURE

Add 3 drops of Assay Buffer to buffer well 'B' and allow the reaction to occur for 20 minutes.

Read Result in minutes.20

Advantage MAL CARD

In-house evaluationSensitivity: Specificity: 100% 99.95%

For detection of P. falciparum - pLDH & Plasmodium Species (P. falciparum/ P. vivax/ P. malariae/ P. ovale - pLDH) in Human Whole Blood

For detection of P. falciparum - HRP-2 & Plasmodium Species (P. vivax - pLDH) in Human Whole Blood

Advantage MALARIA CARD

In-house evaluationSensitivity: Specificity: 100% 99.77%

Advantage P.f MALARIA CARDFor detection of P. falciparum - HRP-2 in Human Whole Blood

In-house evaluationSensitivity: Specificity: 100% 99.80%

Advantage Malaria PAN + P.f CARDFor detection of P. falciparum - HRP-2 & Plasmodium Species (P. falciparum/

P. vivax/ P. malariae/ P. ovale - pLDH)in Human Whole Blood For detection of Plasmodium Species (P. falciparum/ P. vivax/ P. malariae/ P. ovale - pLDH) in Human Whole Blood

Advantage PAN MALARIA CARD

In-house evaluationSensitivity: Specificity: 100% 99.8%

Individually pouched Single Tests - Practical & Safe

Analytical Sensitivity of 100-200 parasite per µl blood

See through Device

Longer Shelf Life 24 months at 4-30ºC

Easy to Interpret Colour Bands

Result within 20 minutes

Convenient Pack size: 50 Tests & 100 Tests

Panel Detection Score: (P.v) Specificity: 97.1%* 99.60%*

*As per WHO, Geneva evaluation

Individually pouched Single Tests - Practical & Safe

Analytical Sensitivity of 50-100 parasite per µl blood

See through Device

Longer Shelf Life 24 months at 4-30ºC

Easy to Interpret Colour Bands

Result within 20 minutes

Convenient Pack size: 50 Tests & 100 Tests

Panel Detection Score: (P.v & Pf) Specificity: 100%* 100%*

Individually pouched Single Tests - Practical & Safe

Analytical Sensitivity of 50-200 parasite per µl blood

See through Device

Longer Shelf Life 24 months at 4-30ºC

Easy to Interpret Colour Bands

Result within 20 minutes

Convenient Pack size: 25 Tests

Individually pouched Single Tests - Practical & Safe

Analytical Sensitivity of 100 parasite per µl blood

See through Device

Longer Shelf Life 24 months at 4-30ºC

Easy to Interpret Colour Bands

Result within 20 minutes

Convenient Pack size: 50 Tests & 100 Tests

Panel Detection Score: (P.v) Specificity: 100%* 99.6%*

*As per WHO, Geneva evaluation

Important Note: Discard the DEVICEimmediately after reading results as it is potentially infectious.

STEP 1

CCCPPP

FFF

Add 4 µl of the anti-coagulated blood sample using sample dropper or micropipette (or finger prick sample) to the sample well ‘S’. Make sure that the blood from the sample dropper has been completely transferred to the sample pad.

STEP 2

CCCPPP

FFF

STEP 3

CCCPPP

FFF

*As per WHO, Geneva evaluation

Individually pouched Single Tests - Practical & Safe

Analytical Sensitivity of >50 parasite per µl blood

See through Device

Longer Shelf Life 24 months at 4-30ºC

Easy to Interpret Colour Bands

Result within 20 minutes

Convenient Pack size: 25 Tests

Panel Detection Score: Specificity: 99%* 100%*

*As per WHO, Geneva evaluation

Page 3: MALARIAMALARIAtheadcode.com/.../Catalogue-Malaria-All-Product.pdf · 2020-06-01 · MALARIAMALARIA re-emerging as world No.1 infectious Killer Malaria is the most common infectious

Positivity rate (pDLH)

Positivity rate (aldolase)

Panel detection score (pLDH)

Panel detection score (aldolase)

Figure 15: Phase-2 Plasmodium spp. (pan or P. vivax/Pvom test line) false-positive rate against clean-negatives

Malaria Rapid Diagnostic Test Performance, Results of WHO product testing of malaria RDTs: Round 5 (2013), Page No.: 46Website: http://apps.who.int/iris/bitstream/10665/128678/1/9789241507554_eng.pdf

Note : The above information is provided for the scientific community, It is not for commercial or promotional purpose.*

BR

/CM

R/0

11

R-0

9

Spe

cific

atio

n/D

esig

ns a

re s

ubje

cted

to c

hang

e w

ithou

t any

obl

igat

ion

on th

e pa

rt o

f th

e m

anuf

actu

rer

*Products Performance as per WHO, Geneva and FIND, Genevain 2013, WHO, Geneva and FIND (Foundation for Innovative New Diagnostics), Geneva launched an evaluation

program to assess the performance of commercially available malaria RDTs and their results are:Figure 13: Phase-2 P. vivax panel detection score and

positivity rate at 200 parasites/µL

Pa

ne

l d

ete

ctio

n s

core

b/P

osi

tivi

ty r

ate

c (%

)

Malaria Rapid Diagnostic Test Performance, Results of WHO product testing of malaria RDTs: Round 5 (2013), Page No.: 44Website: http://apps.who.int/iris/bitstream/10665/128678/1/9789241507554_eng.pdf

Advantage MalariaPan + P.f Card

Advantage Mal Card

Phase-2 evaluation panel consisted of 35 clinical

blood samples containing wild-type P. vivax; .

RDTs performed = 2 tests x 2 lots at 200 p/µL

and 1 test x 2 lots at 2000 p/µL

Advantage Pan Malaria Card

Advantage Mal Card

Advantage Pan Malaria Card

Advantage Malaria Pan + P.f Card

Phase-2 evaluation panel consisted of 100 Plasmodium

spp. -negative samples, of which 59 were clean negatives

from healthy volunteers with no known current illness or

blood abnormality.

pDLH

Aldolase

Fa

lse

-po

siti

ve r

ate

(%

)

For further enquiries, Please contact:

J. Mitra & Co. Pvt. Ltd.A 180-181, Okhla Indl. Area, Phase-1, New Delhi - 110 020, INDIATel: +91-11-47130300, 47130500, 26818971-73E-mail: [email protected] Website : www.jmitra.co.in

ISO 13485:2016ICMED 13485

ISO 9001:2015

Also Connect with us on: