HCY™ Feline herpesvirus Real-time PCR Detection Kit

• Designed based on the gene sequences of pathogens prevalent in various regions of the world, fully guaranteeing the accuracy and validity of the test;
• The primers are designed with special bases to reduce the risk of missed detection due to gene mutation;
• Adopting pre-filled freeze-dried microsphere technology for transportation and storage at room temperature;
• Easy to use, no need to prepare reagents in advance;
• The minimum detection limit is 2 copies/Test;
• Clinical sensitivity 100%, specificity 100%;
• Add internal standard to prevent false negative results and facilitate indoor quality control.

Quality by Design

An evolutionary tree was constructed based on the sequences of FHV-1 isolates. The sequences of virulent strain YBYJ1-33HR, virulent strains, and other Chinese feline herpes sequences indexed on NCBI in China were compared with the sequences of NCBI reference strains (NC_013590.2), and the sequences of other countries’ regions FHV_CU1-112 (Thailand), MH070323-MH070348, ( USA) and other sequences were compared for homology. An evolutionary tree was constructed to analyze the homology between 99.2-99.5%.

HCY™ Feline herpesvirus Real-time PCR Detection Kit is designed and developed based on the gene sequences of endemic pathogens in different regions of the world, as mentioned above, which fully ensures the accuracy and validity of the detection. At the same time, special bases are introduced in the primer sequence synthesis process to reduce the risk of missed detection due to gene mutation.

LoD and PCR Efficiency

Using real clinical samples, the assay was performed after serial gradient dilution, and the results showed good linear characteristics, and the calculated copy number was as low as 2 copies/Test. Calculation of the experimental data set yielded R2=0.995 and the amplification efficiency E=98.71%.

Sensitivity and Specificity

The HCY™ Feline herpesvirus Real-time PCR Detection Kit was compared to similar commercially available products and tested a total of 127 real clinical samples, of which the sensitivity was 100% and the specificity 100%.

		Reference Product		Total
		Negative	Positive
HCY™ PCR Test Kit	Positive	0	14	14
	Negative	113	0	113
Total		113	14	127

	Estimated Value	95% Confidence Interval
Sensitivity	100%	73.24%~100%
Specificity	100%	95.90%~100%

Cross-reactivity

The HCY™ Feline herpesvirus Real-time PCR Detection Kit has been validated for the detection of Bartonella, Borrelia burgdorferi, Toxoplasmosis, Leptospira, Bordetella bronchiseptica Feline Calicivirus, Feline coronavirus, Feline Parvovirus, Chlamydia felis, Mycoplasma haemofelis, Candidatus Mycoplasma haemominutum and Candidatus Mycoplasma haemominutum. Candidatus Mycoplasma turicensis, Canine parainfluenza Virus, Canine Coronavirus, Canine Herpesvirus, Canine Distempervirus, and Canine Parvovirus. None of them cross-reacted.

Test principle of the Feline Herpesvirus Antigen Test Kit

This product uses rapid immunochromatography technology to detect feline herpes virus antigen in feline eye and nasal secretions. When the diluted sample was dropped into the sample well, if there was FHV antigen in the sample, it would specifically bind to the recombinant protein labeled with colloidal gold to form a complex that moved along the chromatographic membrane and was captured by the FHV antibody coated on the membrane, showing a Burgundy line on the detection line (T). If the FHV antigen is not present in the sample, no visible lines are formed at the T position. No matter the result is negative or positive, the C line should be colored, otherwise the result is invalid.

Components of the FHV-Ag Test Kit

Component	CY-FHVAG-01 (1 test)	CY-FHVAG-10 (10 tests)	CY-FHVAG-25 (25 tests)
Test device in foil bag (including test card,pipette &desiccant)	1 pc	10 pcs	25 pcs
Extraction vial/cap (contains extraction buffer solution)	1 vial and cap	10 vials and caps	25 vials and caps
Sampling swab	1 pc	10 pcs	25 pcs
IFU	1 pc	1 pc	1 pc

Storage conditions and Validity Period:

Store at 2-30°C and be valid for 24 months.

Sample Requirements of Feline Herpesvirus Antigen Test Kit

• Please refer to the instructions for use
• This kit is only suitable for testing feline whole blood or serum samples (hemolysis and hyperlipidemia samples cannot be used).
• Collect fresh samples and immediately put into the extraction buffer solution, which should be detected as soon as possible within 1 hour.
• If samples were not timely detected, store within 24 hours at 2-8°C and store within 1 month at -20°C.

Product Performance Indifelineors

1. Sensitivity ≥ 95%.
2. Specificity ≥ 97.5%.
3. Precision: no more than one false negative and false positive results within the batch; the test lines & control line (cards) between three lots shall be uniform, and no more than one time of color difference between lots.
4. Stability: valid for 24 month if unopened & store 2-30°C.

Interpretation of Results

Negative: Only the C line appears as a red color.
Positive: Both T and C lines appear purplish red.
Invalid: No color appears in the C line.

NOTE: Invalid test results can be caused by a variety of reasons and should be re-tested.

Test Principle of the Feline Herpesvirus Antibody Test Kit

This product uses a rapid immunochromatographic technique for the detection of antibodies to feline herpesvirus in whole blood or serum of felines. When the diluted sample was dropped into the sample well, if there was FHV antibody in the sample, it would specifically bind to the recombinant protein labeled with colloidal gold to form a complex that moved along the chromatographic membrane and was captured by the FHV antigen coated on the membrane, showing a Burgundy line on the detection line (T). In the absence of FHV antibody in the sample, no visible lines are formed at the T position. No matter the result is negative or positive, the C line should be colored, otherwise the result is invalid.

Components of the FHV-Ab Test Kit

Component	CY-FHVAB-01 (1 test)	CY-FHVAB-10 (10 tests)	CY-FHVAB-25 (25 tests)
Test device in foil bag (including test card,pipette &desiccant)	1 pc	10 pcs	25 pcs
Extraction vial/cap (contains extraction buffer solution)	1 vial and cap	10 vials and caps	25 vials and caps
Extraction vial/cap (contains extraction buffer solution)	1 pc	10 pcs	25 pcs
IFU	1 pc	1 pc	1 pc

Storage Conditions and Validity

Store at 2-30°C and be valid for 24 months.

Product Performance Indifelineors

1. Sensitivity ≥ 95%.
2. Specificity ≥ 97.5%.
3. Precision: no more than one false negative and false positive results within the batch; the test lines & control line (cards) between three lots shall be uniform, and no more than one time of color difference between lots.
4. Stability: valid for 24 month if unopened & store 2-30°C.

Sample Requirements of Feline Herpesvirus Antibody Test Kit

1. Please refer to the instructions for use
2. This kit is only suitable for testing feline whole blood or serum samples (hemolysis and hyperlipidemia samples cannot be used).
3. Collect fresh samples and immediately put into the extraction buffer solution, which should be detected as soon as possible within 1 hour.
4. If samples were not timely detected, store within 24 hours at 2-8°C and store within 1 month at -20°C.

Interpretation of Results

Negative: Only the C line appears as a red color.
Positive: Both T and C lines appear purplish red.
Invalid: No color appears in the C line.

NOTE: Invalid test results can be caused by a variety of reasons and should be re-tested.