AccuBioTech ABT-IDT-B99 Malaria p.f Rapid Test Instructions

: June 9, 2024
: AccuBioTech

Table of Contents

ABT-IDT-B99 Malaria p.f Rapid Test
INTRODUCTION
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ABT-IDT-B99 Malaria p.f Rapid Test
Instructions

ABT-IDT-B99 Malaria p.f Rapid Test

This package insert is applied to the below products:
Catalog No. Product Name
ABT-IDT-B99 Malaria p.f./pan Cassette(WholeBlood)
INTENDED USE
ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating antigens of histidine-rich protein II (HRP-II) antigen of Plasmodium falciparum and common Plasmodium lactate dehydrogenase (pLDH) of Plasmodium species in human whole blood. The test can also distinguish malarial infections between P. falciparum (P.f) and non-P.f Plasmodium species. It is intended for professional use, only for diagnostic test and reactive samples should be confirmed by a supplementary assay such as microscopic examination of thin blood smear.

INTRODUCTION

Malaria is caused by a protozoan which invades human red blood cells.1 World Health Organization estimates that 3.3 billion were at risks of acquiring malaria in 2006, with 247 million of these developing clinical malaria (86% in Africa), and nearly 1 million (mostly African children) dying from the disease.2 Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century.3 The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology.
ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) is a rapid test to qualitatively detect the presence of the P.f-specific HRP-II antigen and/or Pan-malarial pLDH antigen found in all plasmodium species. The test utilizes colloid gold conjugate to selectively detect HRP-II and pLDH in human whole blood specimens.
PRINCIPLE
ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.fspecific HRP-II antigen and/or Pan- malarial pLDH antigen in whole blood specimens. The membrane is pre-coated with anti-HRP-II antibody and anti-pLDH antibody. During testing, the whole blood specimen reacts with the anti-HRP-II antibody and anti-pLDH antibody dye conjugate, which has been pre-coated on the test strip. The mixture then migrates upward on the membrane by capillary action, reacts with anti-HRP-II antibody on the membrane at “P.f” test region and with anti-pLDH antibody on the membrane at “Pan” test region. If the specimen contains HRP-II and/or pLDH, a colored line will appear in “P.f” region or two colored lines will appear in “P.f” region and “Pan” region. The absence of the colored lines in “P.f” region or “Pan” region indicates that the specimen does not contain HRP- II and/or pLDH. To serve as a procedure control, a colored line will always appear in the control region (“C”) indicating that proper volume of specimen has been added and membrane wicking has occurred.

MATERIALS PROVIDED

Individually packed test devices
Package insert
Disposable specimen pipettes
Buffer

Materials Required but Not provided

Specimen collection container
Pipette and disposable tips (optional)
Timer
Lancets

PRECAUTIONS

For professional in vitro diagnostic use only.
Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
Read the entire procedure carefully prior to performing any tests.
Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established recautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
Humidity and temperature can adversely affect results.
The usezd testing materials should be discarded in accordance with local, state and/or federal regulations.

STORAGE AND STABILITY

The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

SPECIMEN COLLECTION AND PREPARATION

ACCU-TELL® Malaria P.f./Pan Cassette (Whole Blood) can be performed using whole blood.
Both Fingerstick Whole Blood and Venipuncture Whole Blood can be used.
To collect Fingerstick Whole Blood specimens:
Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.
Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger
Puncture the skin with a sterile lancet. Wipe away the first sign of blood.
Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.
Testing should be performed immediately after specimen collection.
Do not leave the specimens at room temperature for prolonged periods. Whole blood collected by venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. For long term storage, specimens should be kept below -20°C. Whole blood collected by fingerstick should be tested immediately.
Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly for more than three times
If specimens are to be shipped, they should be packed in compliance with federal regulations covering the transportation of etiologic agents.

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within an hour.
Place the cassette on a clean and level surface.
For Whole Blood specimen:
•Use a pipette: To transfer 5µL of whole blood to the specimen well, then add 3 drops of buffer (approximately 180µL).
•Use a disposal specimen dropper: Hold the dropper vertically, draw the specimen up to the Fill Line as shown in illustration below (approximately 5µL). Transfer the specimen to the specimen well, then add 3 drops of buffer (approximately 180µL), and start the timer.
Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS
(Please refer to the illustration above) POSITIVE:* Two or Three colored lines appear

P. falciparum or mixed malaria infection:| One line appears in the control region, one line appears in Pan region and one line appears in P.f region.
---|---
P. falciparum infection:| One line appears in the control region, and one line appears in P.f region.
Non-P.f Plasmodium species infection ：| One line appears in the control region and one line appears in Pan region.
NEGATIVE:| Only one colored line appears in the control region.
INVALID:| Control line fails to appear. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

NOTE:

The intensity of color in the test region may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

QUALITY CONTROL

Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

LIMITATIONS OF THE TEST

ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) is for in vitro diagnostic use only. This test should be used for the detection of P.f, P.v, P.o, P.m antigens in whole blood specimens only.
Neither the quantitative value nor the rate of increase in malarial plasmodium concentration can be determined by this qualitative test.
ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) will only indicate the presence of antigens of Plasmodium sp. (P.f, P.v, P.o, P.m) in the specimen and should not be used as the sole criterion for the diagnosis of malaria infection.
As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended.
A negative result does not at any time preclude the possibility of malaria infection.

PERFORMANCE CHARACTERISTICS
Analytical sensitivity ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) for the detection of P.f and Non-P.f malaria according to the level of parasite

| No. of parasites/ uL of blood| Microscopy (no. of positive)| ACCU-TELL’ Malaria p.f./pan Cassette (Whole Blood)| Sensitivity
---|---|---|---|---
P.f| 1-100| 12| 11| 92.%
101-200| 15| 15| 100%
201-500| 10| 10| 100%
500-1000| 9| 9| 100%

1000| 7| 7| 100%
Total| 53| 52| 98.%
Non-| 1-100| 38| 37| 97.%
101-200| 43| 43| 100%
201-500| 37| 37| 100%
500-1000| 28| 28| 100%
1000| 12| 12| 100%
Total| 158| 157| 99.4./0

Clinical sensitivity and specificity

Reference method (Microscopy)	Result of Malaria P.f/Pan	Total
Positive	Negative
P.f	Positive	52
Negative	1	235
Non-P.f	Positive	157
Negative	1	262

Relative sensitivity: 99.1%（96.6%-99.7%）
Relative specificity: 99.6%（98.6%-99.9%）
Precision
Intra Assay
The run precision has been determined by using 10 replicates of specimens containing negative, low and high positive samples. The negative and positive values were correctly identified >99% of the time.
Inter Assay
Between run precision has been determined by using the same specimens of negative, low positive and high positive of 10 independent assays and with three different lots of ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood). The negative and positive values were correctly identified >99% of the time. Testing was performed using three independent device lots, at three testing sites, on five separate days, and by three operators. Testing was performed over five days (alternating morning/ afternoon). The negative and positive values were correctly identified >99% of the time. ACCU-TELL® Malaria p.f./pan Cassette(Whole Blood) demonstrated acceptable repeatability and reproducibility used by trained professionals.
LITERATURE REFERENCES

Bill MaConell, Malaria Laboratory Diagnosis. January 2001.
WHO, WHO World Malaria Report 2008. 2008, WHO – Global Malaria Programme: Geneva.
Cooke AH, Chiodini PL, Doherty T, et al, Comparison of a parasite lactate dehydrogenase-base immunochromatographic antigen detection assay with microscopy for the detection of malaria parasite in human blood samples. Am J Trop Med Hyp,1999, Feb: 60(2):173-2.

GLOSSARY OF SYMBOLS

| GLOSSARY OF SYMBOLS| | Temperature limitation
---|---|---|---
****| Consult instructions for use| | Batch code
| In vitro diagnostic medical device| | Use by
| Manufacturer| | Do not reuse

Version #: HAX-1110016320
Effective Date: 2020-08