INTENDED USE Feline Immunodeficiency Virus Ab Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Feline Immunodeficiency Virus antibody (FIV Ab) in cat's blood. PRINCIPLE OF THE ASSAY Feline Immunodeficiency Virus Ab Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough FIV antibody in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of FIV antibody in the sample. INTERPRETATION OF RESULTS Positive: The presence of both C band and T band, no matter T band is clear or vague. Negative: Only clear C band appears. Invalid: No colored band appears in C zone, no matter whether T band appears. STORAGE The kit can be stored at room temperature (2-30C). The test kit is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test kit in direct sunlight.
1. INTENDED USE FIV Ab + FeLV Ag Combined Rapid Test is a combined cassette to differentially diagnose the presence of Feline Immunodeficiency antibody and Feline Leukemia Virus antigen in cat's blood. Assay Time: 10-15 min Sample: serum, plasma or whole blood 2. PRINCIPLE OF THE ASSAY FIV Ab + FeLV Ag Combined Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has two testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough FIV antibody or FeLV antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of FIV antibody or FeLV antigen in the sample. 3. KIT COMPONENT - 10 foil pouches, each containing a cassette,pipette and desiccant - 10 assay buffer tubes (0.5 mL each) - 10 centrifugal tubes - Product Manual
One Step Influenza A Test is a rapid qualitative assay that detects influenza type A (including the subtype H1N1) nucleoprotein antigen extracted from the nasal swab specimen. The device is used to aid in the diagnosis of influenza type A infection. For in vitro diagnostic use only. For professional use only. Influenza A SUMMARY Influenza (commonly known as flu) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease that is easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. Influenza outbreaks occur each year during the autumn and winter months. There are three types of influenza viruses: A, B, and C. Only influenza A viruses are further classified by subtype on the basis of the two main surface glycoproteins hemagglutinin (HA) and neuraminidase (NA). Influenza A subtypes and B viruses are further classified by strains. Humans can be infected with influenza types A, B, and C viruses. Subtypes of influenza A that are currently circulating among people worldwide include H1N1, H1N2, and H3N2 viruses. Influenza B viruses can cause morbidity and mortality among humans, but in general are associated with less severe epidemics than influenza A viruses. Although influenza type B viruses can cause human epidemics, they have not caused pandemics. Influenza type C viruses cause mild illness in humans and do not cause epidemics or pandemics. Influenza A PRINCIPLE One Step Influenza A Test is a rapid immunochromatographic test for the visual detection of influenza type A antigen (nucleoprotein) extracted from the nasal swab specimen. The test adopts double antibody sandwich method. When the extracted specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with antibody-dye conjugate, and flows across the membrane pre-coated with influenza type A monoclonal antibody. When the influenza type A antigen levels are at or above the target cutoff (the detection limit of the test), type A antigen in the specimen binds to the specific antibody-dye conjugate and are captured by influenza type A monoclonal antibody immobilized in the relative site of test region T of the device. This produces a colored test band in the test region. When the influenza type A antigen levels are zero or below the target cut off, there is not a visible colored band in the test region of the device. This indicates a negative result for influenza type A.
Intended Use The One Step HAV IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Hepatitis A Virus (HAV) in Whole Blood /Serum / Plasma to aid in the diagnosis of Hepatitis A Virus. Summary Hepatitis A is an acute, usually self-limiting disease of the liver caused by hepatitis A virus (HAV). HAV is transmitted from person to person, primarily by the faecal-oral route. The incidence of hepatitis A is closely related to socioeconomic development, and seroepidemiological studies show that prevalence of anti-HAV antibodies in the general population varies from 15% to close to 100% in different parts of the world. One step HAV IgG/IgM Test is a simple, visual qualitative test that detects Hepatitis A Virus antibodies in human Whole Blood /Serum / Plasma. The test is based on immunochromatography and can give a result within 15 minutes. Principle The One Step HAV IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of Hepatitis A Virus antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing HAV recombinant envelope antigens conjugated with Colloid gold (HAV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-HAV, T2 band is coated with antibody for the detection of IgG anti-HAV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-HAV, if present in the specimen, will bind to the HAV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a HAV IgG positive test result and suggesting a recent or repeat infection. IgM anti-HAV if present in the specimen will bind to the HAV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a HAV IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device. Storage and Stability Store as packaged in the sealed pouch at room temperature or refrigerated (4-30 or 40-86). The test device is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use.
Syphilis Test INTRODUCTION Anti-Syphilis Test is a rapid direct binding test for the visual detection of anti-syphilis antibodies in serum as an aid in the diagnosis of syphilis infection. Test results are read visually without any instrument. It is based on the principle of double antigen sandwich immunoassay for determination of syphilis antibodies in serum. Purified recombinant syphilis antigens are employed to identify anti-Syphilis antibodies specifically. This one step test is very sensitive and only takes about 10 to 20 minutes. Syphilis Test SPECIMEN COLLECTION For serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use the serum for testing. If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly. Syphilis Test PROCEDURE Strip 1.When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch. 2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the MAX (maximum) line. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, onabsorbent surface (e.g., mouth of the serum container). 3.Wait 10-15 minutes and read result. Do not read results after 20 minutes. Cassette 1. Open a pouch containing a cassette, lay the cassette. 2. Using the plastic pipettor provided, draw about 2-3 drops (100mL) the sample into the sample well of the cassette. 3. Read results within 10-15 minutes. Do not read results after 20 minutes. INTERPRETATION OF RESULTS Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable Anti-Syphilis in the serum. Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of Anti-Syphilis. Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device. Syphilis Test PRECAUTION: 1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid 2. Use it before expiry date. 3.The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator. 4 .Old Serum can not be used. If the serum is thick, it can be used only after being separated. Syphilis Test LIMITATIONS The test is for in-vitro diagnostic use only.
General Information One-Step neisseria gonorrhoeae antigen test is detection of neisseria gonorrhoeae in female endocervical swab and male urethral swab specimens. Specimen: Swab/Urine Reading Time : 10-15 min
The One Step TORCH IgG/IgM Test is a panel of rapid qualitative lateral flow test designed for the quantitive detection of IgG and IgM antibodies to Toxoplasma gondii (TOXO), Cytomegalovirus (CMV), Rubella, Herpes Simplex Virus (HSV) in human serum/plasma samples.
General Information One-Step Beta lactam + Tetracycline Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Beta lactam and Tetracycline residue in milk. Specimen: Milk Reading Time : 5-10min
SUMMARY Bilirubin: This test is based on the coupling of bilirubin with a diazotized dichloroaniline in a strongly acid medium. The colors range from light tan to reddish-brown. Ketone: This test is based on the reaction of acetoacetic acid with sodium nitroprusside in a strongly basic medium. The colors range from beige or buff-pink color for a Negative reading to pink and pink-purple for a Positive reading. Specific Gravity: This test is based on the apparent pKa change of certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or blue-green in urine of low ionic concentration to green and yellow-green in urine of higher ionic concentration. Blood: This test is based on the pseudoperoxidase action of hemoglobin and erythrocytes which catalyzes the reaction of 3,3, 5, 5-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue. pH: This test is based on the well known double pH indicator method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range from red-orange to yellow and yellow-green to blue-green. Protein: This test is based on the protein error-of-indicator principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a �??Negative�?? reaction to yellow-green and green to blue-green for a �??Positive�?? reaction. Urobilinogen: This test is based on a modified Ehrlich reaction in which p-diethylaminobenzaldehyde reacts with urobilinogen in a strongly acid medium. Colors range from light pink to bright magenta. Nitrite: This test depends on the conversion of nitrate to nitrite by the action of Gram-negative bacteria in the urine. The nitrite reacts with p-arsanilic acid to from a diazonium compound in an acid medium. The diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h) quinolin to produce a pink color. Leukocytes: This test is based on the action of esterase present in leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. The indoxyl ester liberated reacts with a diazonium salt to produce a beige-pink to purple color. Ascorbic Acid: The composition comprises of a complex chelating agent with a polyvalent metal ion in its higher state and an indicator dye that can reacts with the metal ion in its lower state to produce a color change from blue-green to yellow.
PRINCIPLE Progesterone (P4) is a kind of steroid hormone. The concentration change of P4 in milk is one specific characteristic indicating the activities of cow ovary. It plays an important role in the process of maternal reproduction and maintaining pregnancy. Therefore, it can be monitoring cow reproductive activity by detecting the concentration of P4. P4 concentration has different characteristic changes as the cow's stage of reproductive physiology, through to detect the progesterone levels can make an accurate diagnosis of cow in early pregnancy. PRODUCT FEATURES The strip can be used for diagnosis of cow early pregnancy, which is of high accuracy, easy operation, rapid and normal temperature storage, easy to carry, harmless to maternal and fetal safety. THE SCOPE OF USE The test is mainly suitable for dairy and beef cattle early pregnancy diagnosis, as well as to guide timely artificial insemination. THE BEST USE DATE Cow's estrus cycle is 21 days. There are individual differences in 18 to 24 days commonly, it is suggested to perform the test the 18th days after mating. Perform the test once every day for 5 continuous days; even if one negative result appears during the five days, which indicates the cow is not pregnant and P4 is at the lowest level at this moment. In this case, it was suggested to have the dairy cow mated in time; that should improve the conception rate. If positive results show for all 5 days tests, it indicates the cow is in pregnancy, and it should get careful nursing and gestation management. Another test method is to closely observe the cow rutting performance from 18 days after mating, if it was in rutting performance the detection should do immediately; for those that have no heat after mating to do a test on the 24th day. SPECIMEN COLLECTION 1.Milk sample: cleaning teats before take the milk, abandon to the first three milk, then collect milk in the bottle, take 1 ml in the test tube, placed the centrifuge10000 rpm for 10 minutes, in vitro milk sample was divided into three layers, using straws inserted in the underlying absorbing liquid cream and set aside. 2.Saliva: from the mouth collecting saliva for 3 to 5 ml placed the centrifuge 1500-2000 rpm for 5 minutes, take supernatant on standby. 3.The galley proof: from the hair root galley proof according to take 10 mg in the extracting pipe, add 3 ml anhydrous ethanol soak vortex shock 5 minutes after 2-3 hours, placed 3000 rpm centrifuge for 5 minutes, drain on ethanol solution 1 ml into glass dish, in 70-80 �?? oven dry reoccupy after 1 ml PBS dilution. Set aside. 4.Urine: can be used directly. 5.Blood: anticoagulant take 1 to 2 ml of centrifugal 2000 rpm 5-10 minutes from the plasma standby, the anticoagulant let stand for 30 minutes to separate serum blood clots. Set aside.
Home Menopause Test Strip is an in vitro diagnostic (IVD) qualitative test for rapid detection of human Follicle Stimulating Hormone (FSH) in urine at a sensitivity of 25mIU/ml. SUMMARY AND EXPLANATION OF THE TEST Follicle Stimulating Hormone (FSH) is a peptide hormone produced in the pituitary gland of the brain. It is normally present in the blood or urine varying in concentration with the stage of the menstrual cycle. When estrogen levels drop, FSH is released from the pituitary gland indicating that either a woman in mid-menstrual cycle or the onset of perimenopause. During early menopause, changes take place in the balance of hormones that regulate and control menstrual cycles. As a woman grows older and passes out of childbearing stage of life, the ovaries gradually make less of the hormone estrogen and FSH increases.FSH normally regulates the growth and development of an egg. Once this part of the monthly cycle is complete, FSH production is stopped and it returns to normal. As the body decreases estrogen production with age, more FSH is made. Over time these hormone changes cause menstrual periods to stop completely and "menopause" has occurred. The slow change in ovary function can happen between 2 and 10 years before the final period. This early stage before menopause is called perimenopause. During this stage, the levels of FSH may rise to positive levels and slowly return to normal, causing irregular or missed periods. The testing for FSH should be performed twice to help identify the levels of FSH throughout a menstrual cycle. PRECAUTION 1. For in vitro diagnostic use only. 2. Do not use after expiration date. 3. Test device should remain sealed until ready for use. Do not use if pouch is damaged or opened. 4. Read this instruction carefully before performing the test. 5. Do not re-use the test device. 6. Do not eat the desiccant in the pouch.
AMP INTENDED USE The AMP Gold Rapid Screen Test is a qualitative competitive binding immunoassay for determination of Amphetamine in urine. AMP PRINCIPLE The Amp Gold Rapid Screen Test is a chromatographic absorbent device in which drug or drug metabolites in a sample compete with drug antigen immobilized on a porous membrane support for limited antibody sites. Labeled antibody-dye conjugate mixes with sample specimen and binds to the free drug presented in sample forming an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone immobilized antigen conjugate when the drug is presented in the sample urine above the detection levels (1000ng/ml for Amphetamine). Unbound dye conjugate binds to the reagent in the control zone and produces a pink-rose color band, demonstrating that the reagents and device are functioning correctly. A negative specimen produces two distinct color bands, one for the control in the �¢??C�¢?? zone and one for Amphetamine in the �¢??T�¢?? zone. AMP REAGENTS AND MATERIALS PROVIDED 1. Test Device A pouched cassette contains a single test for Amphetamine 2. Dropper A transfer pipette seal in foil pouch together with test device 3. Operating Instructio MATERIALS REQUIRED BUT NOT PROVIDED AMP MATERIALS REQUIRED BUT NOT PROVIDED Packaging Details: Pouch+Box+Carton packaging (1) With our companyâ??s Logo (2) With the natural package (3) With OEM package (4) ODM Anna Lee Int'l Market Executive
General Information One-Step TB IgG/IgM Rapid Test is detection antibodies(IgG and IgM) anti-Mycobacterium Tuberculosis(M.TB) in human blood. Sensitivity :86.7% , Specificity : 90% Specimen : Serum, Plasma or Whole Blood Reading Time : 10 min
General information One-step cdv + cpv ag combined rapid test is a combined cassette to diagnose the presence of canine disteimper virus antigen and canine parvovirus antigen in dog’s secretions, serum or feces. Sensitivity : cdv 100% cpv 99.3% Specificity :cdv 99.8% cpv 99.4% Specimen: secretions, serum or feces Reading timen:5-10 min
General information Feline infectious peritonitis virus ag test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of fip-triggerred coronavirus antigen(fcov ag) in cat’s feces, serum and ascites. Assay time: 10 - 15 min Sample: mixture of serum and feces extraction, ascites or secretions
General information Method: double antibodies sandwich method Sensitivity : 100% Specificity : 99.8% Specimen : ocular and nasal secretions, serum, plasma Detection limit: 101.9 tcid50 / 0.1 ml No cross reaction against cpv, ccv, civ, cpiv Reading time : 5- 10 min
General information One-step cow pregnancy rapid test is to improve milk output and shortening the period of non-pregnancy. Analytical sensitivity : 2ng/ml Sensitivity : 96.9% , specificity : 97.8% Specimen : milk Reading time : 5 min No cross-reactivity: fsh (100g/ml), e2(10g/ml), prl(100g/ml), lh(25miu/ml), dht(10g/ml), tetraborane(10g/ml) and h2o.
General information One-step tumor marker rapid test is an immunochromatography based one-step in vitro diagnostics test for the qualitative determination of afp, psa and cea in human serum or plasma. Afp : alpha-feto protein test to detect liver cancer Psa : prostate-specific antigen test to detect prostate cancer Cea : carcinoembryonic antigen test to detect colorectal cancer Specimen : serum or plasma Reading time : 20 min
General Information The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the detection of one or more of the following analytes in urine: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite , Leukocytes and so on.
General Information One-Step Troponin I /CK-MB/ Myoglobin Rapid Test is intended for the qualitative determination of cardiac disease in human serum, plasma or whole blood.
