Accu-Tell® HCV Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma)

ACCU-TELL® HCV Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to Hepatitis C Virus in whole blood, serum or plasma. For professional in vitro diagnostic use only.

CATALOG

Product Name	Specimen	Catalog No.	Quantity per box	Certificate
HCV Strip	Whole Blood/Serum/Plasma	ABT-IDT-A12	100T;50T
HCV Cassette	Whole Blood/Serum/Plasma	ABT-IDT-B12	50T;20T

KEY POINTS

Detection for:antibody to Hepatitis C Virus in whole blood, serum or plasma;

Specimen volume:Serum or Plasma specimen: 25 μL, or

Venipuncture Whole Blood specimen: 50 μL, or

Fingerstick Whole Blood specimen: 50 μL

Reading time:10 minutes;

Relative sensitivity:100.0% (95%CI*: 99.3%~100.0%);

Relative specificity:99.8% (95%CI*: 99.4%~100%);

Accuracy:99.9% (95%CI*:99.6%~100.0%).

*Confidence Intervals

INTRODUCTIONof

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well-documented non-A, non-B hepatitis.

INTENDED USE

ACCU-TELL®HCV Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to Hepatitis C Virus in whole blood, serum or plasma.

For professional in vitro diagnostic use only.

TEST PROCEDURE

For Cassette

Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

For Venipuncture Whole Blood specimen:Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen area, then add 2 drops of buffer (approximately 80 μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50 μL of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80 μL) and start the timer. See illustration below.

We are .

For Strip:

Bring the pouch to room temperature before opening it. Remove the test Strip from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

For Venipuncture Whole Blood specimen:Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μL) to the specimen area, then add 2 drops of buffer (approximately 120μL), and start the timer. See illustration below.

For Fingerstick Whole Blood specimen:

To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of test strip, then add 2 drops of buffer (approximately 120 μL) and start the timer. See illustration below.

PERFORMANCE CHARACTERISTICSof

Sensitivity and Specificity

The recombinant antigen used for ACCU-TELL®HCV Cassette (Whole Blood/Serum/Plasma)is encoded by genes for both structural (nucleocapsid) and non-structural proteins. ACCU-TELL®HCV Cassette (Whole Blood/Serum/Plasma) has passed a seroconversion panel and compared with a leading commercial HCV test using clinical specimens.

The results show that the relative sensitivity of ACCU-TELL®HCV Cassette (Whole Blood/Serum/Plasma) is 100%, and the relative specificity is 99.8%.

Method		Leading commercial HCV test		Total Results
ACCU-TELL® HCV Cassette	Results	Positive	Negative
	Positive	410	3	413
	Negative	0	1644	1644
Total Results		410	1647	2057

Relative sensitivity: 410/410=100.0% (95%CI*: 99.3%~100.0%);

Relative specificity: 1644/1647=99.8% (95%CI*: 99.4%~100%);

Accuracy: (410+1644)/ =99.9% (95%CI*:99.6%~100.0%).

*Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 20 replicates of three specimens: a negative, a HCV low titer positive and a HCV high titer positive. The negative, HCV low titer positive and HCV high titer positive values were correctly identified 100% of the time.

Inter-Assay

Between-run precision has been determined by 20 independent assays on the same three specimens: a negative, a HCV low titer positive and a HCV high titer positive. Three different lots of ACCU-TELL®HCV Cassette (Whole Blood/Serum/Plasma) have been tested over a 3-month period using negative, HCV low titer positive and HCV high titer positive specimens.The specimens were correctly identified 100% of the time.

Cross-reactivity

ACCU-TELL®(Whole Blood/Serum/Plasma) has been tested by HAMA, RF, HBsAg, HBsAb, HBeAg, HBeAb, HBcAb, Syphilis, HIV, 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 HCV negative and positive specimens.

Acetaminophen: 20 mg/dL

Caffeine: 20 mg/dL

Acetylsalicylic Acid: 20 mg/dL

Gentisic Acid: 20 mg/dL

Ascorbic Acid: 2g/dL

Albumin: 2 g/dL

Creatin: 200 mg/dL

Hemoglobin 1000mg/dL

Bilirubin: 1g/dL

Oxalic Acid: 60mg/dL

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

LIMITATIONS

4. We are .

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

Другие товары поставщика

	Accu-Tell® Single Drug of Abuse Rapid Test Cassette (Saliva)	Accu-Tell®(Saliva) is a One Step chromatographic immunoassay for the detection of drugs in human saliva at the cut-off concentrations. CATALO...
	Accu-Tell® Multi-Drug Saliva Rapid Test Cassette	Accu-Tell®for AMP/MET/COC/OPI/THC/PCP/MTD/MDMA/OXY/COT/BZO/KET/6-MAM is a lateral flow chromatographic immunoassay for the qualitative dete...
	Accu-Tell® Multi-Drug Rapid Test Panel (Urine)	Accu-Tell®Multi-Drug Rapid Test Panel (Urine) is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and dr...
	Accu-Tell® HBeAb Rapid Test Cassette (Serum/Plasma)	ACCU-TELL® HBeAb Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of HBeAb in serum or ...
	Accu-Tell® HBsAg Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma)	ACCU-TELL®HBsAg Rapid Test Cassette/Strip (Whole Blood /Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of ...

Все товары поставщика

Похожие товары

	Digital Construction	Продавец: FJ Dynamics Co., Ltd.	We don’t do construction, but we are transforming construction. FJD machine control system ...
	FJD WiFi Camera for Autosteering Kit	Продавец: FJ Dynamics Co., Ltd.	$299.00 Tax excluded. Taxes and Shipping calculated at checkout Quantity: 1 Compatible wi...
	Extension Sets	Продавец: Shanghai Kohope Medical Devices Co., Ltd.	Now, we provide various types of extension sets, including iv extension set with injection port, ...
	Next Generation Sequencing Platform	Продавец: CapitalBio Technology Co, Ltd.	NGSPlatforms Overview A high-throughput sequencingplatform is built around the Bioelectron 4000 ...
	Chicken IgY	Продавец: Hanzghou Frenovo Biotech Co.,Ltd.	The IgY isotype control could be used in FC, ELISA and Flisa experiments. Each batch of the produ...