Human Simplex Virus Rapid Test Herpes Simplex Hsv1/2igg/Igm Rapid Test

• Customization: Available
• Type: Detection Card
• Used for: Igg and Igm Antibodies to Hsv1/2 Test
• Model NO.: HHSV074T
• Specimen: Whole Blood, Serum or Plasma
• Assay Time: 10-15 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Introduction

INTENDED USE
The Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to HSV 1/2 in whole blood, serum or plasma to aid in the diagnosis of HSV 1/2 infection.


MATERIALS
Materials Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge

Timer Lancets

Test Procedure

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.

For Serum or Plasma Specimens: 
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5μl), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) and start the timer. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens:
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90μl) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 10µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90µL) 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.


INTERPRETATION OF RESULTS

IgG POSITIVE: The colored line in the control line region (C) appears, and a colored line appears in test line region G The result is positive for HSV virus specific-IgG and is probably indicative of secondary HSV infection.
 
 

 

IgM POSITIVE: The colored line in the control line region (C) appears, and a colored line appears in test line region M. The result is positive for HSV virus specific-IgM antibodies and is indicative of primary HSV infection.

 

 

IgG AND IgM POSITIVE: The colored line in the control line region (C) appears, and two colored lines should appear in test line regions G and M. The color intensities of the lines do not have to match. The result is positive for IgG & IgM antibodies and is indicative of secondary HSV infection.

 

NEGATIVE: Only one colored band appears in the control region (C). No line appears in test line regions G or M.





 

 

INVALID: No Control line (C) appears. 

 

Performance

PERFORMANCE CHARACTERIST

1. Clinical Sensitivity, Specificity and Accuracy

The Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial HSV PCR kit.
Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Testvs. PCR kit

HSV Infection	Result	IgM	IgG
Primary Infection	Positive	101	94
	Negative	3	8
	Total	104	102
	Relative Sensitivity	97.12%	92.16%
Secondary Infection	Positive	98	101
	Negative	7	5
	Total	105	106
	Relative Sensitivity	93.33%	95.28%
Non-HSV Infection	Positive	2	1
	Negative	378	379
	Total	380	380
	Relative Specificity	99.47%	99.74%

For the primary and secondary infection, the overall sensitivity is 94.48%, the overall specificity is 99.61% and the overall accuracy is 97.79%.
Detection Of Limit
The results show that the minimum detection limit of HSV IgG was 256 times dilution. The minimum detection limit for HSV IgM is 512 times dilution.
Hook Effect
The present test results show that the hook effect of HSV IgG is 256 times higher and that of HSV IgM is 512 times higher.

2. Precision
Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of the time.

Inter-Assay
Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of the Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Testhave been tested using these specimens. The specimens were correctly identified >99% of the time. 

Cross-Reactivity
The Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test has been tested for anti-HAV IgG, HBsAg, anti-HCV IgG, anti-HIV IgG, anti-RF IgG, anti-Syphilis IgG, anti-H. Pylori IgG, anti-CMV IgG, anti-CMV IgM, anti-Toxo IgG, anti-Toxo IgM, anti-Rubella IgG, anti-Rubella IgM positive specimens. The results showed no cross-reactivity.

Interfering Substances
The following compounds have also been tested using the Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Test and no interference was observed.

Acetaminophen  (20 mg/dL)	Caffeine (20 mg/dL)	Acetylsalicylic Acid (20 mg/dL)
EDTA (20 mg/dL)	Ascorbic Acid(2g/dL)	Glucose (20mg/dL)
Ethanol (10%)	Hemoglobin  (500 mg/dL)	Bilirub (1000 mg/dL)