Test principle of the Feline Coronavirus Antibody Test Kit

The Feline Coronavirus Antibody Test Kit detects antibodies to feline coronavirus using rapid immunochromatography. After whole cat blood, serum, or plasma is added to the sampling hole of the test tape, the sample is moved along the tomographic membrane with the colloidal gold labeled FCoV antigen. If the FCoV antibody is present in the sample, the detection line (T) will show red. No color will appear if the FCoV antibody is not present in the sample..

The Feline Coronavirus Antibody Test Kit is able to detect Feline Coronavirus antibody concentration, demonstrating quantitative results. The test serves only as an aid to the diagnosis, for professional use only.

Intend Use

For rapid screening of feline coronavirus in feline whole blood, serum, or plasma. (FCoV).

Components of the FCoV-Ab Test Kit

Item NO.	Test Cassette	Assay Buffer	Finger-stick Device	Quantitative Pipette	Instruction
CY-G003-1 (1 test)	1 pc	1 pc	1 pc	1 pc	1 pc
CY-G003-10 (10 tests)	10 pcs	10 pcs	10 pcs	10 pcs	1 pc
CY-G003-25 (25 tests)	25 pcs	25 pcs	25 pcs	25 pcs	1 pc

Storage conditions and Validity Period:

Store at 2-30°C, valid for 24 months.

Sample Requirements

• The feline Coronavirus Antibody Test Kit is only suitable for testing whole cat blood, serum, or plasma samples.
• The sample should be tested within 1 hour after collection.
• If timely testing is not possible and samples need to be properly stored, whole blood, serum, or plasma samples can be stored at 2-8℃ for 3 days, and serum or plasma samples can be stored at -20℃ for 1 month.

How to Use Feline Coronavirus Antibody Test Kit?

1. Add the collected cat whole blood, serum, or plasma samples to the assay buffer, tighten the lid, and mix upside down.
2. Aspirate 3 drops (~80 μl) of diluted sample from the quantitative pipette into the spiked wells of the assay tape.
3. Wait for 10-15 min at room temperature to read the test results. After 20 min, the test results are invalid.

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 various reasons and should be re-tested.

Product Performance

Sensitivity ≥ 95%

Specificity ≥ 97.5%

Stability: 2-30 ℃ unopened validity period of 2 years

Precautions for using the Feline Coronavirus Antibody Test Kit

• Do not use it if the product has expired or the foil bag is damaged.
• If the Feline Coronavirus Antibody Test Kit is removed from cryopreservation, it should be opened after returning to room temperature and used within 1 hour.
• Avoid contact with the sample wells and laminar strips on the test tape.

HCY™ Feline Coronavirus 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 5 copies/Test;
• Clinical sensitivity 100%, specificity 99.11%;
• Add internal standard to prevent false negative results and facilitate indoor quality control.

Quality by Design

FIP virus strain reference sequence (NC_002306.3), and China, Japan, Italy together included 147 for comparison, the combined FECV sequence 3580 gene sequences (NC_002306.3) gene comparison results analysis, for the construction of an evolutionary tree to confirm the existence of multiple subspecies of FECV + FIPV homology in the region of China (NC_ 002306.3) for homology comparison and constructing evolutionary tree analysis.

HCY™ Feline Coronavirus 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 5 copies/Test. Calculation of the experimental data set yielded R²=0.998 and the amplification efficiency E=95.9%.

Sensitivity and Specificity

The HCY™ Feline Coronavirus PCR Detection Kit was compared to similar commercially available products and tested 127 real clinical samples, of which the sensitivity was 100% and the specificity 99.11%.

		Reference Product		Total
		Negative	Positive
HCY™ PCR Test Kit	Positive	1	15	16
	Negative	111	0	127
Total		112	15	127

	Estimated Value	95% Confidence Interval
Sensitivity	100%	74.65%~100%
Specificity	99.11%	94.40%~100%

Cross-reactivity

The HCY™ Feline Coronavirus PCR Detection Kit is used for Bartonella, Borrelia Burgdorferi, Toxoplasmosis, Leptospira, Bordetella bronchiseptica, Feline calicivirus, Feline herpesvirus, Feline Parvovirus, Chlamydia felis, Mycoplasma haemofelis, Candidatus Mycoplasma haemominutum and Candidatus Mycoplasma turicensis, Canine parainfluenza Virus), Canine Coronavirus, Canine Herpesvirus, Canine Distemper virus, Canine Parvovirus, no cross-reactivity.

Cat coronavirus is weakly resistant to external physical and chemical factors and can be inactivated by most disinfectants.

Principle of Feline Coronavirus Test Kit

The Cat Coronavirus Test Kit uses a rapid immunochromatographic assay technique to detect feline coronavirus antigens. Samples obtained from cat feces and vomit are added to the spiked wells and moved along the chromatographic membrane with a colloidal gold-labeled anti-FCoV monoclonal antibody. If the FCoV ag is present in the sample, it binds to the antibody on the detection line (T) and shows a burgundy color. If the FCoV antigen is absent in the sample, the feline coronavirus test cassette does not produce a color reaction.

The Feline Coronavirus Antigen Test Kit is able to detect Feline Coronavirus Antigen concentration, demonstrating quantitative results. The test serves only as an aid to the diagnosis. For professional use only.

Intend Use

For rapid screening of Feline Coronavirus in feces and vomit of cats. (FPV).

Components of the FCoV Ag Test Kit

Cat No.	Test Cassette	Diluent	Disposable Swab	Instruction
CY-G004-1	1 pc	1 pc	1 pc	1 pc
CY-G004-10	10 pcs	10 pcs	10 pcs	1 pc
CY-G004-25	25 pcs	25 pcs	25 pcs	1 pc

Storage Conditions and Validity Period:

Store at 2-30°C, valid for 24 months.

Sample Requirements

• The cat coronavirus test kit is only suitable for testing cat feces and vomit samples.
• The test sample should be collected fresh and put into the dilution solution immediately, and the diluted sample should be tested within 1 hour.
• If the sample cannot be tested in time, the diluted sample can be stored at 2-8℃ for 24 hours and -20℃ for 1 month.

How to Use Feline Coronavirus Test Kit

1. Use disposable cotton swabs to collect samples of cat feces and vomit; stir the sample into the diluent, let it sit for 1 minute, then remove the swab, tighten the lid, and invert the tube to mix the sample with the diluent.
2. Tear the aluminum foil bag of the test card, take out the test card, and put it on a flat, clean table.
3. Draw 3 drops (about 80μl) of the diluted sample with a straw and add it to the well of the test cassette.
4. Wait 10 to 15 minutes at room temperature before interpreting the test result. The test result after more than 20 minutes is invalid.

Note: The above interpretation time is carried out at room temperature 15-30℃. You should extend the interpretation time if the temperature is lower than 15℃. You should shorten the interpretation time if the temperature exceeds 30℃.

Interpretation of Results

Negative: Within the detection window, only the control line (C) has a purple-red band.

Positive: Within the detection window, the test line (T) and the control line (C) appear as red bands.

Invalid: In the detection window, the control line (C) does not appear purple-red band.

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

Cat Coronavirus Test Kit Performance

Sensitivity ≥ 95%

Specificity ≥ 97.5%

Precision: There are no more than one false negative and false positive judgment results within a batch; the color development of the test line and the control line between the three batch number test strips (cards) between batches should be uniform, and the color development between batches is not uniform. There is no more than one judgment result.

Stability: 2-30 ℃ unopened validity period of 2 years

Precautions for Using the FCoV Test Kit

• Please read the instructions carefully before the test. The various reagents provided by this product are only for this test.
• You cannot use products with expired or damaged aluminum foil bags.
• If the kit is taken out under low-temperature storage, it must be returned to room temperature before opening. You should use opened test card as soon as possible to avoid moisture, and it should not exceed 1 hour.
• Avoid touching the sample well on the test card and the chromatographic strip at the test window.
• The waste after the test should be regarded as a pollutant and properly disposed of according to relevant local regulations.