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A COMPENDIUM OF PERFORMANCE DATA
ISO 9001: 2000, ISO 13485(2003), NF EN ISO 13485 (2004)
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AUGUST 2 0 0 9
The Clinically Trusted RDT
M A L A R I A · R D T
PARASCREEN PAN / Pf
PARASCREEN Pan / Pf
1 The Clinically Trusted RDTPARASCREEN Pan / Pf
2
Sr. No. Parameters Parascreen Pan / Pf Specifications
1 Detection system Two site, double antibody sandwich qualitative immunoassay system
2 Gold Conjugate Mouse monoclonal IgG class Anti Pf. HRP-II specific / monoclonal Anti-Pan specific antibodies conjugated to colloidal gold. Monoclonal IgG class Anti Pf. HRP-II specific antibody improves specificity and binding to target analyte. Monoclonal Anti-Pan specific antibodies helps differentiate Pf and other malarial species and in the follow-up of antimalarial therapy.
3 Migration Platform Small pore sized nitro cellulose membrane.Small pore sized membrane deliberately slows down migration of reactants to enhance antigen / antibody contact time. Improves sensitivity and signal density.
4 Blocker used for Heterophile HBR (Heterophile Blocking Reagents) used to improve specificityantibodies by blocking RFand HAMA interference.
5 Clearing buffer Proprietary buffer to effectively lyse parasitized red cells and efficiently extract parasites and target antigen.
6 Numbers of drops of buffer used Four
7 Antibody pair to detect Tracer region: Monoclonal IgG class Anti Pf. HRP-II P. falciparum conjugated to colloidal gold.
Capture region: Monoclonal IgM class Anti Pf. HRP-II antibodies.
8 Antibody pair to detect Pan Tracer region: Monoclonal Anti-Pan specif ic pLDH malaria antibodies conjugated to colloidal gold.
Capture region: Monoclonal Anti-Pan specific pLDH antibodies.
9 Control line system Inbuilt and independent of analyte detection systemTracer region: Rabbit IgG - colloidal gold conjugate Capture region: Anti Rabbit IgG.Non - functional rabbit globulins conjugated to gold is co-dried with IgG class Anti Pf. HRP-II and Anti-Pan specific pLDH is captured at the control band by Anti-rabbit IgG. The control line formation and intensity is constant and its independent of functional Anti Pf. HRP-II and Anti-Pan colloidal gold.
10 Sample volume 5 µl whole blood
11 Sample dispensing system Loop
12 Test duration 20 minutes
13 Steps involved in test procedure Two steps
14 Sensitivity With microscopy positive samples: 100% correlation (In-house study)Sensitivity in excess of 95% in most global clinical evaluations.
15 Specificity 100% specific to Pf. HRP-II and Pan specific pLDH (In-house study)Specificity in excess of 95% in most global clinical evaluations.
016 Storage 4 - 30 C
17 Stability 24 months
18 Pack sizes Single test, 10 tests & 25 tests
19 Lancets & Swabs Can be provided as per agreement
20 Packaging Each test device is seal packed in a moisture proof aluminum pouch with a desiccant. The colour change system of the desiccant alerts users if the pouch integrity has been compromised before use.
The Clinically Trusted RDTPARASCREEN Pan / Pf
Countries Around The World To Which Parascreen Pan / Pf Is Exported
1. Myanmar2. Singapore3. Oman4. Ethiopia5. Philippines6. Thailand7. Austrailia8. Indonesia9. Netherlands
10. Ghana11. U.K.12. Peru13. Tanzania14. Ireland15. Kenya16. Republic of Benin17. Equador18. Burundi
4 The Clinically Trusted RDTPARASCREEN Pan / Pf
Parascreen Pan / Pf Production in Quantity of Tests since the Year 2003 till Date
5
Parascreen Production in number of tests
20
03
-20
04
20
04
-20
05
20
05
-20
06
20
06
-20
07
20
07
-20
08
20
08
-20
09
0
20
00
00
40
00
00
60
00
00
80
00
00
10
00
00
0
12
00
00
0
14
00
00
0
16
00
00
0
18
00
00
0
20
00
00
0
20
90
0
88
07
1
14
24
32
3
58
17
18
18
77
69
4
86
86
01
Year
Quantity in numbers
Mo
re t
han
4.7
5 m
illio
n t
ests
in 4
yea
rs
The Clinically Trusted RDTPARASCREEN Pan / Pf
Comparison of Fluorescent Microscope Detection of Malarial Parasites Using Acridine Orange with Malarial Antigen Detection by Parascreen
9
The study was conducted at the Microbiology Department of Choithram Hospital and Research Centre, Indore during the period January 2004 to December 2006.
Aim: To compare the sensitivity and specificity of two different methods namely fluorescent microscope detection and Rapid antigen detection test for the detection of malarial parasites.
Samples used:The samples of suspected cases of malaria in Indore city and referred to Microbiology Department of Choithram Hospital and Research Centre were included for the study.
Methods:Fluorescent study by using Acridine Orange: 50 ml EDTA blood sample was mixed with 25 ml Acridine Orange stain over a glass slide and the drop covered with cover glass (22 x 50 mm). The wet preparation was examined under fluorescent microscope for Trophozoites and Gametocytes of Plasmodium falciparum and Plasmodium vivax. (Method as described by Nanda et. al, IJPM, 1999). Antigen detection: Parascreen rapid antigen detection kits were used through out the study.
Observations:There were 3 samples (*), which showed dual infection (P. falciparum and P. vivax) and could not be differentiated by Parascreen. Two samples showed antigen positivity for P. falciparum but the microscopy did not show the presence of parasites and on clinical history the patients had received quinine for the past 2-3 days. Thus, antigen detection was not a false positive.
Conclusion:All samples showed total correlation between Parascreen antigen detection method and fluorescent microscopy. The sensitivity and specificity of Parascreen obtained is 100%.
The results are displayed year-wise in the following tables as follows:Comparison of Fluorescent Microscopy with Parascreen rapid antigen detection kit in the year 2004
Month Positive cases P. falciparum positive P. vivax positive
Microscopy Antigen Microscopy Antigen
January 11 11 11 0 0
February 1 1 1 0 0
March 3 2 2 1 1
April 6 3 3 3 3
May 3 1 1 2 2
June 5 2 2 3 3
July 8 5 5 3 3
August 24 21 21* 4 4*
September 29 25 25 4 4
October 69 58** 59 10 10
November 15 14 14 1 1
December 6 6 6 0 0
Total 180 149 150 30 30
* Cases showing dual infection as evident with microscopy.** Microscopic finding negative for the case on quinine treatment.
The Clinically Trusted RDTPARASCREEN Pan / Pf
Comparison of Fluorescent Microscopy with Parascreen rapid antigen detection kit in the year 2005
Month Positive cases P. falciparum positive P. vivax positive
Microscopy Antigen Microscopy Antigen
January 7 6 6 1 1
February 6 6 6 0 0
March 6 5 5 1 1
April 7 6 6 1 1
May 26 3 3 3 3
June 2 0 0 2 2
July 10 5 5 5 5
August 12 11 11 1 1
September 24 20 20* 5 5*
October 14 12 12 2 2
November 12 10 10 2 2
December 1 0 0 1 1
Total 107 84 84 24 24
* Cases showing dual infection as evident with microscopy.
Comparison of Fluorescent Microscopy with Parascreen rapid antigen detection kit in the year 2006
Month Positive cases P. falciparum positive P. vivax positive
Microscopy Antigen Microscopy Antigen
January 3 3 3 0 0
February 1 0 0 1 1
March 0 0 0 0 0
April 2 0 0 2 2
May 6 5** 6 0 3
June 12 3 3 9 9
July 7 4 4 3 3
August 3 0 0 3 3
September 9 5 5 4 4
October 32 29 29* 4 4
November 18 11 11 7 7
December 1 1 1 0 0
Total 107 84 84 24 24
* Cases showing dual infection as evident with microscopy.** Microscopic finding negative for the case on quinine treatment.
The Clinically Trusted RDTPARASCREEN Pan / Pf 10
11
Evaluation of Parascreen Tests, Rural Kenya, May 2005, Kit Biomedical Research, Amsterdam
The study was conducted in a meso endemic area in the Central Province of Kenya during the transmission season of May 2005.
Aim: To compare and evaluate the performance of Parascreen compared to gold standard microscopy.
Samples used:The study was conducted using one hundred eighty-four samples obtained from children between 6 months and 12 years with the clinical suspicion of uncomplicated malaria.
Method:Finger prick blood was taken from children between 6 months and 12 years with the clinical suspicion of uncomplicated malaria. Rapid diagnostics tests were performed on the spot under field conditions (ambient temperature) and interpreted within the time indicated by the manufacturer. Another drop of finger prick blood was used to make thin and thick films for microscopy which were examined by experienced microscopists for 300 fields at 1000X magnification.
Observations:Of the 184 samples tested, 124 samples tested negative in microscopy and 60 samples tested positive for P. falciparum of which three samples were identified as having P. malariae infection. The Parascreen tests correctly identified all 57 P. falciparum samples which were confirmed by microscopy. Eight microscopically negative samples were found positive in Parascreen tests and only one test failure (no control line visibility) was observed in the study.
Conclusion:The sensitivity of Parascreen is 100% and specificity of 92.8% when compared with microscopy. The results of this study are also published in the Journal of Tropical Medicine and International Health, Volume 12, No. 2, pp: 238 - 244, February 2007, titled as “Is molecular biology the best alternative for diagnosis of malaria to microscopy? A comparison between microscopy, antigen detection and molecular tests in rural Kenya and urban Tanzania”.
Evaluation of a Rapid Malaria Diagnostic Test Parascreenfor Malaria Diagnosis in the Peruvian Amazon
The study was conducted under field conditions in Loreto-Peru between October and December 2006.
Aim: To validate a rapid malaria diagnostic test Parascreen under field conditions.
Samples used:The study was conducted using 332 samples obtained from individuals having symptoms related to malaria and who attended to the health services between October and December 2006.
Method:A total of 332 samples on individuals with symptoms related to malaria were tested using Parascreen. The results obtained by the rapid malaria diagnostic test were compared with Polymerase Chain Reaction (PCR) and expert microscopy (EM). The indicators calculated for Parascreen were sensitivity (S), specificity (E), positive (PV+) and negative (PV-) predictive value and positive (LR+) and negative (LR-) likelihood ratio.
Conclusion:Parascreen is valid and acceptable for malaria diagnosis under field conditions. Its use must consider the incidence and predominance of Plasmodium species.
The Clinically Trusted RDTPARASCREEN Pan / Pf
12
Field Evaluation of a Rapid Immunochromatographic Test Kit for the Diagnosis of Plasmodium falciparumand non-falciparum Malaria Parasites from Assam
The study was conducted in Sonitpur District in Assam.
Aim: To compare and evaluate the performance of Parascreen compared to gold standard microscopy.
Samples used:A total of 126 patients from Sonitpur District, Assam were tested for malaria.
Method:A total of 126 samples on individuals with symptoms related to malaria were tested by Parascreen ICT (Immunochromatographic test) and microscopic examination of blood smears.
Observation:Sixty-one (48.41%) patients were diagnosed with malaria by microscopic examination, 52 were infected with P. falciparum and 9 with P. vivax. With Parascreen, the sensitivity and specificity rates for P. falciparum and P. vivax were 96.30% and 88.88%, and 98.48% and 98.48% respectively.
Conclusion:Parascreen is a rapid and useful tool for the diagnosis of malaria.
Evaluation of Parascreen at Malaria Research Centre (ICMR)
The study was conducted at Malaria Research Centre (ICMR), Campal, Panaji, Goa.
Aim: To compare and evaluate the performance of Parascreen compared to gold standard microscopy.
Samples used:Fresh whole blood directly from finger prick of fever cases in passive collection and detection facility were used. Thick and thin blood smears were simultaneously prepared for microscopy.
Method:A total of 197 patients having fever and with symptoms related to malaria were tested by Parascreen ICT (Immunochromatographic test) and microscopic examination of blood smears.
Observation:
Total Tested (% +ve) Pv (% +ve) Pf (% +ve) Pv + Pf (% +ve)
Microscopy 197 (38.0) 68 (34.5) 7 (3.55) 0 (-)
Parascreen 197 (38.0) 68 (34.5) 7 (3.55) 0 (-)
P. falciparum P. vivax
Sensitivity (%) 100 100
Specificity (%) 100 100
Conclusion:Parascreen is a rapid and useful tool for the diagnosis of malaria and shows 100% sensitivity and specificity when compared with microscopy.
The Clinically Trusted RDTPARASCREEN Pan / Pf
