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Accu-Tell® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood)

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ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of four kinds of circulating plasmodium falciparum(P. falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.) in whole blood.
Product Description

CATALOG

Product Name

Specimen

Catalog No.

Quantity per box

Certificate

Malaria p.f./p.v./pan Cassette

Whole Blood

ABT-IDT-B236

30T/15T

CE


KEY POINTS

Detection for: four kinds of circulating plasmodium falciparum(P. falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.) in whole blood.

Specimen volume: 5μL of whole blood;

Reading time: 10 minutes;

Relative Sensitivity for P.f.-specific antigens: >99.9 %

Relative Sensitivity for Pan-malarial antigens: 98.0%

Relative Specificity: >99.9%

Accuracy: 99.8%

 

INTRODUCTION

Malaria is caused by a protozoan which invades human red blood cells. Malaria is one of the world's most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants, young children.

 

INTENDED USE

ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of four kinds of circulating plasmodium falciparum(P. falciparum (P.f.), P. vivax (P.v.), P. ovale (P.o.), and P. malariae (P.m.) in whole blood.

 

TEST PROCEDURE

1.  Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2.  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.

3.  Wait for the colored line(s) to appear. Read results at 10 minutes.  Do not interpret the result after 20 minutes.

 Malaria pv pf pan 5.png

PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) has been tested with microscopy on clinical samples. The results show that the overall sensitivity of P. falciparum and P. vivax were >99.9% and 98.0% when compared to results obtained with microscopy.

Specificity

ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) uses antibodies that are highly specific to Malaria P.f.-specific and Pan-malarial antigens in whole blood. The results show that the specificity of ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) is >99.9%, when compared to results obtained with microscopy.

Method

Microscopy

Total Results

ACCU-TELL® Malaria p.f./p.v./pan   Rapid Test Cassette (Whole Blood)

Results

Positive

Negative

P. v.

P. f.

Positive

50*

82**

0

132

Negative

1

0

432

433

Total Results

51

82

432

565

Comment:Blood Samples infected by Plasmodium falciparum (n = 82), Plasmodium vivax (n = 51) were included, as well as 432 malaria negative samples to be confirmed with microscopy.

Note:  * There was one P. vivax sample to show a pan line and a P.f. line.

          ** There were two P. falciparum samples that they both showed a pan line and a P.f. line.

The comparison for Pan line has been only done with blood specimens positive with Plasmodium vivax specimen. The claims for Pan lines are based on scientific findings that Pan specific LDH is found in other malarial parasites including Plasmodium ovale and Plasmodium malariae.

Relative Sensitivity for P.f.-specific antigens: 82/82>99.9 %( 95%CI***: 96.4%~100.0%)

Relative Sensitivity for Pan-malarial antigens: 50/51= 98.0% (95%CI***: 89.6%~100.0%)

Relative Specificity: 432/432>99.9% (95%CI***: 99.3%-100.0%)*

Accuracy: (50+82+432)/(82+51+432)=564/565=99.8%(95%CI***: 99.0%-100.0%)

***Confidence Intervals

Minimum Detection Level

Type

Parasites/mL

P. falciparum

200

Plasmodimum non-falciparum species (P. vivax)

1500

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of four specimens: a negative, a P.f. positive, a P.v. positive and an P.f./P.v. dual positive. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same four specimens: negative, a P.f. positive, a P.v. positive and an P.f./P.v. dual positive. Three different lots of ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) have been tested using these specimens. The specimens were correctly identified >99% of the time.

Cross-reactivity

ACCU-TELL® Malaria p.f./p.v./pan Rapid Test Cassette (Whole Blood) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, HCV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity.

Interfering Substances

The following potentially interfering substances were added to Malaria negative and positive specimens.

Acetaminophen:       20 mg/dL                      Caffeine:          20 mg/dL

Acetylsalicylic Acid:  20 mg/dL                      Gentisic Acid:   20 mg/dL

Ascorbic Acid:          20 mg/dL                       Albumin:               2 g/dL

Creatin:                  200 mg/dL                       Bilirubin:                1g/dL                      

Oxalic Acid:              60mg/dL

None of the substances at the concentration tested interfered in the assay.

 

LIMITATIONS

ACCU-TELL® Malaria p.f./p.v./pan Rapid Test 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 P.f., P.v., P.o., and P.m. concentration can be determined by this qualitative test.

ACCU-TELL® Malaria p.f./p.v./pan Rapid Test 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.


Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.