INTENDED USETMEzDx Malaria Pan/Pf is a rapid in-vitro immuno - chromatographic immunoassay for

the qualita�ve detec�on of malaria infec�on in human blood sample indica�ng differen�al diagnosis between P. falciparum, HRP-II (Plasmodium falciparum, his�dine-rich protein II) and other Plasmodium species (Pan, pLDH) (P. vivax, P. ovale and P. malariae). The test is intended for primary screening of malaria infec�on in symptoma�c pa�ents of all age groups including neonates and pregnant women. The test is intended for professional use and must be used by a trained personnel.

CLINICAL SIGNIFICANCE

Malaria is a serious, some�mes fatal, parasi�c disease. It is characterized by fever with chills, anemia and is caused by Plasmodium parasite that is transmi�ed from one human being to another by the bite of infected Anopheles mosquitoes. Four species of the Plasmodium parasite are responsible for malaria infec�ons in humans viz. P. falciparum, P. vivax, P. ovale and P. malariae. Of these, P. falciparum and P. vivax are the most prevalent. Early detec�on and differen�a�on of malaria is of paramount importance due to incidence of cerebral malaria and drug resistance associated with falciparum malaria causing most of the morbidity and mortality worldwide.

PRINCIPLETMEzDx Malaria Pan/Pf test u�lizes the principle of immuno-chromatography. It has

the test strip coated with Monoclonal An� - pLDH Pan an�bodies (test line Pan) specific to the lactate dehydrogenase of Plasmodium species (P. falciparum, P.vivax, P. ovale and P.malariae) and the other (test line Pf) with Monoclonal An�-HRP-II which is specific to the his�dine rich protein-II of P. falciparum. As the test sample flows through the membrane assembly of the device a�er addi�on of the buffer solu�on, the colored colloidal gold, an�-pLDH an�body and the an�- HRP-II an�body conjugate complexes with the lysed blood sample. The malarial an�gens get immobilized on the respec�ve test lines on the nitrocellulose membrane which leads to the forma�on of red/purple colored band/s. The unreacted conjugate and unbound complex if any moves further on the membrane and are subsequently immobilized at the control “C” region forming a red/purple band. This control band serves to validate the test performance and should always appear.

MATERIALS PROVIDEDTMA EzDx Malaria Pan/Pf kit contains the following items to perform the assay:TM1. EzDx Malaria Pan/Pf Test Device individually foil pouched with a Desiccant

2. Sample Applicator3. Alcohol Swab 4. Lancet 5. Buffer Solu�on. 6. Product Insert.B Ac�ve ingredients of main components are: 1 test strip includes : Gold conjugate: Mouse monoclonal an�bodies specific to

Pan pLDH gold colloid, mouse monoclonal an�bodies specific to Pf - HRP-II gold colloid. Test line Pan: Mouse monoclonal an�bodies specific to Pan - pLDH, Test line Pf: Mouse monoclonal an�bodies specific to Pf HRP-II, Control line : Goat an�-mouse IgG.

Buffer Solu�on: Casein (q.s), Triton X- 100(q.s)

PRECAUTIONS

1. Read this Insert carefully before carrying out the test and instruc�on must be followed exactly to get accurate results.

2. The Device is sensi�ve to humidity as well as to heat. Therefore take out the Device from sealed pouch just before carrying out the test.

TM3. Store the EzDx Malaria Pan/Pf kit at the temperature men�oned on the kit in a dry atmosphere.

4. Do not use the kit a�er the expira�on date.5. Do not mix reagents from different lots.6. For in-vitro diagnos�c use only.7. Wear protec�ve gloves while handling samples and wash hands thoroughly a�er

performing the test.8. Dispose all the samples and kits properly as per the instruc�ons a�er test in

accordance with GLP.9. Do not pipe�e reagents or blood samples by mouth.

Detection of Pan(pLDH) & Pf(HRP-II) Antigen

(1)

Rapid Test Detection Kit

MALARIA Pan/Pf

MATERIALS REQUIRED BUT NOT PROVIDED Timer

Ref. No.: 001RMA010KI - 10

(3)

Samples

90 88 02

Nega�ve

97.77

Sensi�vity(%)

—

Specificity(%)

120 117 03 97.50 —

Malaria Nega�ve

190 04 186 — 97.89

(2)

SYMBOL LEGENDSSymbol Explanation of symbol Symbol Explanation of symbol

Consult instruction for use

Do not use if package is damaged

In vitro diagnostic device

Store at 2 c - 40 c

Keep away from sunlight

Do not re-use

Keep Dry

Batch code No.

Manufacturer

Date of Manufacture

Use by (date or month of expiry)

2

2

PACK SIZE PRODUCT CODE

1 Test / Kit RK MAL 001 - 1

10 Tests / Kit RK MAL 001 - 10

25 Tests / Kit RK MAL 001 - 25

50 Tests / Kit RK MAL 001 - 50

Date Issued: 2017-01

ORDERING INFORMATION

10. Do not re-use the test.11. Buffer Solu�on : It contains Sodium azide as a preserva�ve, in case of contact with

skin, wash immediately. Wear gloves and eye protec�ve.

SPECIMEN COLLECTION, STORAGE & PRECAUTION

Collec�on by venipuncture

1. Collect the whole blood into the collec�on tube containing an�coagulant (EDTA, Citrate or Heparin) by venipuncture. An�coagulant such as Heparin, EDTA and Citrate do not affect the test results.

o2. If immediate tes�ng is not possible then the samples may be stored at 2-8C for upto 3 days. The samples should be brought to room temperature prior to use. Using the samples in the long term keeping more than 3 days can cause non-specific reac�ons.

EC REP

2. Do not use any other specimen than whole blood.

ensures that drops contain the correct volume of buffer.

Every precau�on has been taken to ensure the diagnos�c ability and accuracy of this product. This product is used outside of the control of the manufacturer and the distributor and the result may accordingly be affected by environmental factors and / oruser error. A person who is the subject of the diagnosis should consult a doctor for further confirma�on of the result.

EC REPAuthorized representa�ve in the European community

ADVY CHEMICAL PVT. LTD.

1.

“Sample Port 1 (S)”.

“Sample Port 1 (S)”

the Buffer Port

The performance characteris�c is inves�gated in specimens posi�ve for P.falciparum and P.vivax only.

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6) Alcohol SwabALCOHOL SWABEXTERNAL USE ONLY

SILICA GELDO NOT EAT

5.

InvalidOther Plasmodium species Positive

(4)

Sample Dropper ( 5µl )

5µl markBloodsample

Sample Loop ( 5µl )

5µl

1

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EzDxTM

MALARIA Pan/PfRapid Test Detection Kit

Detection of Pan (pLDH) and Pf (HRP-II) Antigen

1

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Store at 2 - 40°C Diagnostic Use OnlyIn VitroFor

ADVY CHEMICAL

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Content : 1 Test Device 1 Desiccant

Manufactured in India by :

ADVY CHEMICAL PVT. LTD.Plot No. A - 334 / 336 / 338, A - 337 & 339, Road No. 25 & 26, Wagle Industrial Estate, Thane - 400 604, INDIA.

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