Audited Supplier
HHSV074T
Detection Card
None
None
None
None
5-10 Minutes
3~5days After Get Payment
T/T, Western Union, Paypal
Accpet
PETX
Carton
10Tests/Kit
Hangzhou
38220010
Product Description
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
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PROCEDURE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.
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.
Herpes Simplex Virus HSV1/2 IgG/IgM Rapid Testvs. PCR kit
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.
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.
Intra-Assay
- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- Place the test device on a clean and level surface.
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.
PERFORMANCE CHARACTERIST
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% |
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.
Precision
Intra-AssayWithin-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) |
