Accu-Tell® Malaria P.f. Rapid Test Cassette (Whole Blood)

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Accu-Tell® Malaria P.f. Rapid Test Cassette (Whole Blood)

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ACCU-TELL® Malaria p.f. Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum in whole blood.
Product Description

Product Description

CATALOG

Product NameSpecimenCatalog No.Quantity per boxCertificate
Malaria p.f. CassetteWhole BloodABT-IDT-B85          25T


KEY POINTS

Detection for: circulating plasmodium falciparum (P.f.) in whole blood.

Specimen volume: 10μL of whole blood;

Reading time: 10 minutes;

Relative sensitivity: >99.9% (95%CI*: 96.4%~100.0%);  

Relative specificity: >99.9% (95%CI*: 99.3%~100.0%);

Accuracy: >99.9% (95%CI*: 99.4%~100.0%).      


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. Rapid Test Cassette (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating plasmodium falciparum in whole blood.

 

TEST PROCEDURE

Malaria pf test procedure.jpg

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

2.  Place the Cassette on a clean and level surface.

Use a pipette: To transfer 10μL of whole blood to the specimen well, then add 3 drops of buffer (approximately 180μL), and start the timer.

Use a disposal specimen dropper: Hold the dropper vertically,draw the specimen up to the Fill Line as shown in illustration below (approximately 10μL). Transfer the specimen to the specimen well, then add 3 drops of buffer (approximately 180μL), and start the timer.

PERFORMANCE CHARACTERISTICS

Sensitivity and Specificity

ACCU-TELL® Malaria p.f. Rapid Test Cassette (Whole Blood) uses an antibody that is highly specific for Malaria P.f. antigen in whole blood. ACCU-TELL® Malaria p.f. Rapid Test Cassette (Whole Blood) has been tested with thin or thick blood smears on clinical samples. The results show that the sensitivity of ACCU-TELL® Malaria p.f. Rapid Test Cassette (Whole Blood) is over 99.0% relative to blood smears.And the results show that the specificity of ACCU-TELL® Malaria p.f. Rapid Test Cassette (Whole Blood) is > 99% relative to blood smears.

MethodBlood Smears   MicroscopyTotal Result

ACCU-TELL® Malaria p.f. Rapid Test   Cassette

(Whole Blood)

ResultsPositiveNegative
Positive82082
Negative0432432
Total Result82432514

Relative sensitivity: >99.9% (95%CI*: 96.4%~100.0%);  

Relative specificity: >99.9% (95%CI*: 99.3%~100.0%);

Accuracy: >99.9% (95%CI*: 99.4%~100.0%).      

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 15 replicates of three specimens: negative, low titer positive and high titer positive specimens. The specimens were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 15 independent assays on the same three specimens: negative, low titer positive and high titer positive specimens. Three different lots of ACCU-TELL® Malaria p.f. 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. 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.

 

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

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