Accu-Tell® HBsAb Rapid Test Cassette/Strip (Serum/Plasma)

Accu-Tell®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Antibody to Hepatitis B Surface Antigen in serum or plasma.

CATALOG

Product Name	Specimen	Catalog No.	Quantity per box	Certificate
HBsAb Strip	Serum/Plasma	ABT-IDT-A7	100T;50T
HBsAb Cassette	Serum/Plasma	ABT-IDT-B7	50T;25T

KEY POINTS

Detection for:Antibody to Hepatitis B Surface Antigen in serum or plasma;

Specimen volume:75 μL;

Reading time:15 minutes;

Sensitivity:10mIU/ml of HBsAb;

Relative Sensitivity:>99.9% (97.5%CI*: 98.7%-100%);

Relative Specificity:98.4% (95%CI*: 95.3%-99.7%);

Accuracy:99.3% (95%CI*: 97.9%-99.9%).

*Confidence Intervals

INTRODUCTIONof

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. The antibody to HBsAg, HBsAb, may not become detectable for 3-6 months after acute infection. It is associated with resolution of the illness. This antibody is recognized as the marker of immunity to HBV. As a result, vaccination against HBV was introduced to control the morbidity and mortality associated with the virus.

INTENDED USE

ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Antibody to Hepatitis B Surface Antigen in serum or plasma.

TEST PROCEDUREof

Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30℃) prior to testing.

For Cassette:

For Strip:

Note: A low HBsAb concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 20 minutes.

We also produce and

PERFORMANCE CHARACTERISTICS

Sensitivity

ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) has been tested with a sensitivity panel ranging from 1mIU/ml to 40mIU/ml. The test can detect 10mIU/ml of HBsAb in 15 minutes.

Specificity

Antigen used for ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) is highly specific for detecting HBsAb in serum or plasma. The specificity was comparable to RIA.

Method		RIA		Total Results
ACCU-TELL®HBsAbRapid Test(Serum/Plasma)	Results	Positive	Negative
	Positive	231	3	234
	Negative	0	180	180
Total Results		231	183	414

Relative Sensitivity: >99.9% (97.5%CI*: 98.7%-100%)

Relative Specificity: 98.4% (95%CI*: 95.3%-99.7%)

Accuracy: 99.3% (95%CI*: 97.9%-99.9%)

*Confidence Intervals

Precision

Intra-Assay

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

Inter-Assay

Between-run precision has been determined by using the same three specimens of negative, low positive and high positive of HBsAb in 15 independent assays. Three different lots of ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) has been tested over a 3-month period using negative, low positive and high positive specimens. The specimens were correctly identified 99% of the time.

Cross-reactivity

ACCU-TELL®HBsAb Rapid Test Cassette/Strip (Serum/Plasma) has been tested by HAMA, Rheumatoid factor (RF), HAV, Syphilis, HIV, H. Pylori, MONO, CMV, Rubella and TOXO positive specimens. The results showed no cross-reactivity

Interfering Substances

ACCU-TELL®/Strip (Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens. No interference was observed.

In addition, no interference was observed in specimens containing up to 2,000 mg/dL Hemoglobin, 1000 mg/dL Bilirubin, and 2000 mg/dL human serum Albumin.

LIMITATIONS

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® Multi-Drug Rapid Test Saliva Cup	Accu-Tell®ACCU-TELL® Multi-Drug Rapid Test Saliva Cup for AMP/MET/COC/OPI/THC/PCP/MTD/MDMA/OXY/COT/BAR/BZO/BUP/PPX is a lateral flow ch...
	Accu-Tell® Multi-Drug Rapid Test Urine Cup without Lock	Accu-Tell®Multi-Drug Rapid Test Urine Cup is a rapid chromatographic immunoassay for the qualitative detection of multiple drugs and drug m...
	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 ...
	Accu-Tell® Alcohol Rapid Test Strip (Saliva)	Accu-Tell®Alcohol Rapid Test Strip (Saliva) is a One Step method for the detection of Alcohol in human saliva at a cut-off concentration of...
	Accu-Tell® Multi-Drug Rapid Test Urine Cup with Lock	Accu-Tell®Multi-Drugis a rapid chromatographic immunoassay for testing of any combination of the following drugs: AMP/BAR/BZO/BUP/COC/THC/M...

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...