INTRODUCTION

PROCEDURE

1. AccuTest Malaria Pf/Pv test device is a chromatographic

immunoassay kit for rapid qualitative determination of malaria
infection in blood.

Perform the test as given below:

2. AccuTest Malaria Pf/Pv test device can discriminate between

P. falciparum and P. vivax(Pan) infection.

1. Bring the pouch to room temperature before opening to

avoid condensation of moisture on the membrane of the
device. Also bring the specimen to R.T. prior to testing.

3. Results just in 15-20 minutes.

4. AccuTest Malaria Pf/Pv device exhibits sensitivity of 98.8% for
P. falciparum and 97.1% for P. vivax. Specificity for both P. falciparum
and P. vivax is 99%.

2. Label the device with patients identification.

3. Load 5 l of blood sample into the sample injection point
of the test device.
4. Add 4 drops (approx. 100 l) of assay buffer into the well.
Avoid the well to become overflow.
5. Wait for 15 - 20 minutes and read the result. The results
should not be interpreted after 20 minutes.

PRINCIPLE

6. Refer the picture below for interpretation of the test result.

Malarial antigens, LDH (Lactate dehydrogenase) and Aldolase, in

blood sample are allowed to react with anti-LDH and anti-aldolase
monoclonal antibody-coupled gold conjugate followed by reaction
with anti-LDH and anti-aldolase monoclonal antibody immobilized in
the test lines.
When the blood sample is infected with malaria, a visible line appears
in the test region on the membrane.

Appearance of Control line validates the procedure. AccuTest

Malaria Pf/Pv device discriminates between P. falciparum and P. vivax(Pan).

COMPONENTS OF KIT

RESULT INTERPRETATION

* AccuTest Malaria Pf/Pv Test Device

NEGATIVE RESULTS:
* Assay Buffer
Only the control band is visible. Negative result indicates that there
is no malaria infection in the sample.

KIT STORAGE, STABILITY &

HANDLING

POSITIVE RESULTS:

1. The kit should be stored at 2 - 30C. Do not freeze.

Along with the control band, if the T1 or T1 + T2 band appear

together, the sample is infected with P. falciparum. If only the T2
band appears, the blood sample is infected with P. vivax(in usual).

2. Do not use the kit past the expiration date stated on label.

INVALID RESULTS:

3. Take off the device from the sealed pouch just before use as the
device is sensitive to humidity and heat.

If control band does not appear, the test is considered as invalid.

In this case, please repeat the test with new test device.

The test should be performed with freshly collected blood from the
fingertip or by venipuncture, using sample tube containing anticoagulant.
For short term, the specimen can be stored at 2 - 8C. For long term
storage, it should be kept below -20C.

ATM1-2012-07-001

SPECIMEN COLLECTION &

STORAGE

LIMITATIONS & INTERFERENCES

AccuTest Malaria Pf/Pv device is designed for primary screening. The
kit can provide fast and easy result. At the same time the possibility of
false positive or false negative result caused by various factors, cannot
be completely excluded.
Therefore, it is recommended to interpret the result of the test in line with
clinical manifestations, other test results & clinicians view collectively.

PERFORMANCE CHARACTERISTICS
1. Detection Limit
Detection limit of AccuTest Malaria Pf/Pv device is approximately
25 parasites/ml of the blood.
2. Clinical Sensitivity and Specificity
In the clinical performance, AccuTest Malaria Pf/Pv device shows that
its sensitivity is 98.8% for P. falciparum and 97.1% for P. vivax, and that
its specificity is 99.0%. However, if the parasitemia is more than 200
parasites/ml, AccuTest Malaria Pf/Pv device has > 99% of sensitivities
for both P. falciparum and P. vivax.

AccuTest
Malaria Pf/Pv
(n=1,096)
Negatives

Clinic decision by Giemsa Staining/PCR

Positives (n=594)
Negatives
P. vivax (n=334)
(n=502) P. falciparum (n=250)
497

10

Positives

247

334

Accuracy

99.0%

98.8%

97.1%

REFERENCES

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

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MALARIA Pf/Pv

3. Warhurst, D.C. and J.E.Williams. Laboratory diagnosis of malaria.

J.Clin.Pathol. 1996;49:533-538.

MALARIA Pf/Pv

MALARIA Pf/Pv

4. World Health Organization - Geneva, New perspectives of malaria

diagnosis (2000).

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

MALARIA Pf/Pv

1. Malcolm, J.G. et al.Genome sequence of the human malaria parasite

Plasmodium falciparum. Nature. 2002;419:498-511.
2. Perlmann, P. and Troye-Blomberg, M. Malaria parasites and disease.
Malaria Immunology. 2002;Chapter 1:1-4.

AR. NO.: I 102

ATM1-2012-07-001

BIOMEDICAL PVT. LTD.

Head Office - Mumbai : Tel. : 91(022) 67446744; Fax : 91(022) 67446755
E-mail : accurex@vsnl.com ; Website : www.accurex.org
Plant : G-54, MIDC Tarapur, Boisar, Thane - 401 506
Customer Support No. 1800 209 8456

MALARIA Pf/Pv

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