In Vitro Diagnostic Test

 

Introduction Of Singclean Fertility Test Series

Singclean fertility test including human chorionic gonadotropin (HCG) pregnancy test kit, luteinizing hormone (LH) ovulation test kit and follicle stimulating hormone (FSH) test kit.

Singclean human chorionic gonadotropin (HCG) pregnancy test kit (colloidal gold) is a rapid, one-step lateral flow immunoassay for the qualitative delection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG in urine to aid in the early detection of pregnancy for self-testing. It obtained the result from the colored lines.

Singclean luteinizing hormone (LH) ovulation test kit (colloidal gold) is intend for qualitative determination of LH levels in women urine to predict ovulation time, so as to guide reproductive women to choose the optimal conception time or safe period contraception.

Singclean follicle stimulating hormone (FSH) test kit (colloidal gold) is intend for qualitative determination of FSH levels in women urine. It provides some useful information for women who will prepare for pregnancy or focus on ovarian health, functions and fertility, also assists the diagnosis and treatment of pituitary and gonadal dysfunction.

Introduction Of Singclean Multi-Drug One Step Test Kit

Surgiclean® drug of abuse test is a competitive binding immunoassay in which drugs and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. It can detect up to 18 kinds of drugs for urine sample at once including AMP, COC, BAR, BZO, BUP, MET, OPI and other drugs.

Instructions for use for testing of any combination of the following drugs:

Amphetamine (AMP 300), Amphetamine (AMP 500), Amphetamine (AMP), Barbiturates (BAR), Benzoduazepines (BZO100), Benzoduazepines (BZO200), Benzoduazepines (BZO), Buprenorphine (BUP5), Buprenorphine (BUP), Cocaine (COC150), Cocaine (COC), Cotinine (COT), Cotinine (COT 300), Cotinine (COT 600), Methadone metabolite (EDDP), Fentanyl (FYL), Synthetic Cannabis (K2 50), Synthetic Cannabis(K2), Ketamine(KET), Ketamine (KET 500), Methadone (MTD), Methampheamine (MET300), Methamphetamine (MET500), Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA), Methylenedioxymethamphetamine (MDMA 1000), Morphine (MOP 100), Morphine (MOP 200), Morphine (MOP), Methaqualone (MQL), Opiate (OPI), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), Marijuana (THC 25), Marijuana (THC), Tricyclic Antidepressants (TCA), Tramadol (TML), Tramadol (TML300).

Including specimen validity test (S.V.T.) for Oxidants/Pyridinium Chlorochromate (OX/PCC), specific gravity(SG), pH, Nitrite(NIT), Glutaraldehyde (GLUT) and Creatinine (GRE).

 

Principle

The multi-drug test kit is a competitive binding immunoassay in which drugs and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. During testing, a urine specimen migrates through the test device by capillary action. If the drug or drug metabolite concentration in the specimen is below the cut-off level, the anti-drug antibodies in colloidal gold particles will bind to the drug antigens coated in the test line of the nitrocellulose membrane to form a T line which indicates a negative result. If the concentration of drug in the urine specimen is above the cut-off level, it will bind with antibodies conjugated with colloidal gold particles, so that no T line will be developed in the test region, which indicates a positive result. A control band with a different antigen/antibody reaction is added to the immune-chromatographic membrane strip at the control region(C) to indicate that the test has performed properly. This control line should always appear regardless of the presence of drug or drug metabolite. If the control line does not appear the test device should be discarded.

Test Procedure

Equilibrate the tests, urine specimens, and/or controls to room temperature (15-25℃) prior to testing.

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

For Test Cassette

• Place the Test Cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx.100L) to the specimen well (s). Avoid trapping air bubbles in the specimen well (S).
• Start the time and wait for the colored line to appear.
• Read the test results at 5 minutes. Do not read the results after 10minutes.

For Test Panel

• Remove the cap from the end of the test card. With arrows pointing toward the urine specimen, immerse the test panel vertically into the urine specimen for at least 10-15 seconds. Immerse the strip(s) at least the level of the wary lines, but not above the arrow(s) on the test card.
• Place the test panel on a flat dry surface, start the time and wait for the colored

line(s) to appear. Read the test results at 5 minutes. Do not read the results after 10minutes.

For Test Cup

• Collect specimen in the cup and secure the cap tightly.
• If the temperature strip is included with Drug Test Cup, please read urine temperature between 2-4 minutes after voiding to verify the temperature ranges between 32-38℃.
• Place the cup on a flat surface.
• Date and initial the security seal, and place the security seal on the cap.
• Peel off the label on the cup to view the results.
• Read the test results at 5 minutes. Do not read the results after 10minutes.

 

Introduction Of Singclean COVID-19 Test Kit Series

Singclean COVID-19 test kit (colloidal gold method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 novel coronavirus in human nasal cavity. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings.

Singclean COVID-19 antigen test kit saliva swab (colloidal gold) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human saliva. This test provides only a preliminary test result.

Singclean COVID-19 test kit nasopharyngeal swab is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasopharyngeal swab specimen. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 antigen test kit (colloidal gold) must be confirmed with alternative testing method (s) and clinical findings.

Singclean COVID-19 & FLU A/B antigen test kit (colloidal gold) is used for in vitro qualitative detection of 2019 novel coronavirus antigen and influenza A/B antigen in human nasopharyngeal swab samples.

 

Introduction of Singclean infectious disease test series

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Singclean monkeypox virus nucleic acid detection kit (Fluorescence PCR) is used for the detection of nucleic acid from monkeypox virus in serum and human pustular or vesicular rash specimens from individuals suspected of monkeypox virus infectious. By specifically detecting the nucleic acid fragments of monkeypox virus, monkeypox virus can be quickly identified, which is suitable for rapid diagnosis of related diseases caused by monkeypox virus infection. This kit uses polymerase chain reactor-fluorescent probe technology to design specific primers according to the nucleic acid sequence of monkeypox virus for amplification of corresponding nucleic acid fragments. At the same time, the highly specific probe can be combined with the corresponding nucleic acid fragment and hydrolyzed under the action of exonuclease activity to generate fluorescence signal for detection. Real-time amplification curve can be obtained according to the relationship between fluorescence signal and amplification cycle number.

Singclean monkeypox virus antigen test kit is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to Monkeypox virus in human body fluid. This test provides only a preliminary test result. Therefore, any reactive specimen with the monkeypox virus antigen test kit (Immunochromatography) must be confirmed with alternative testing method(s) and clinical findings.

Singclean monkeypox virus IgG/IgM test kit is a solid phase immunochromatographic assay for the rapid, qualitative detection of IgG/IgM antibody to Monkeypox virus in human blood. This test provides only a preliminary test result. Therefore, any reactive specimen with the monkeypox virus IgG/IgM test kit (Immunochromatography) must be confirmed with alternative testing method(s) and clinical findings.

Singclean FLU A/B antigen test kit (colloidal gold) is used for in vitro qualitative detection of influenza A/B antigen in human nasopharyngeal swab samples. It uses colloidal gold immunochromatography to detect influenza A/B virus antigens. The reagent is coated with influenza A virus monoclonal antibody (test line A), influenza B virus monoclonal antibody (test line B) and goat anti-mouse polyclonal antibody (control line C) on a nitrocellulose membrane. The gold label pad contains another influenza A virus monoclonal antibody and influenza B virus monoclonal antibody coupled with colloidal gold. When a sample containing influenza A virus antigen is added to the sample well, the influenza A virus antigen will combine with the influenza A virus monoclonal antibody conjugate to form an antigen-antibody complex. The complex moves through the nitrocellulose membrane. When the complex encounters the influenza A virus monoclonal antibody on the test line A, the complex is captured and purple-red line appeared. When a sample containing influenza B virus antigen is added to the sample well, the influenza B virus antigen is the same as that of influenza A virus antigen. The influenza B virus antigen will color the test line B, a purple-red line appeared. No color band on test line A/B means negative test result. The test kit contains a quality control line (control line C). A purple-red line appears on the control line regardless of the presence or absence of Flu A/B virus antigen in the sample. If the control line is not colored, it means that the test result is invalid regardless of whether the test line is colored. The control line is the criterion for judging whether the test strip is valid.

Singclean HBsAg test kit (colloidal gold) is used for qualitative detection of Hepatitis B surface antigen in human serum or plasma samples. Hepatitis B surface antigen (HBsAg) is the hepatitis b virus coat protein. It's not contagious, only the antigenicity. But it is usually accompanied by the presence of hepatitis b virus, so it is a sign of the hepatitis b virus infection.

Singclean HIV-1/2 antibody urine assay kit (colloidal gold) is used for the qualitative determination of human immunodeficiency virus type I (HIV-1) antibodies and type II (HIV-2) antibodies in human urine samples. It is suitable for the auxiliary diagnosis of HIV infection. The test results are only for clinical reference and cannot be used alone as the basis for confirming or excluding cases. In order to achieve the purpose of diagnosis, the test results should be used in conjunction with clinical examination, medical history and other examinations. This product can be used for consumer self-test.

 

Introduction Of Singclean Kidney Function Rapid Test Series

Singclean kidney function rapid test series including microalbuminuria (MAU) rapid test kit and neutrophil gelatinase-associated lipocalin (NGAL) rapid test kit.

Singclean neutrophil gelatinase-associated lipocalin (NGAL) rapid test kit (colloidal gold) is intended for qualitative determination of NGAL levels in urine in vitro diagnostic. It is used as a supplementary method in the early diagnosis of acute kidney injury (AKI), as NGAL is an early and sensitive biomarker of AKI.

Singclean microalbuminuria (MAU) rapid test kit (colloidal gold) is intended for qualitative determination of albuminuria levels in urine in vitro diagnostic. It is used as a supplementary method in the diagnosis of chronic kidney injury (CKI).

It utilizes colloidal gold labeling and immune chromatography based on the principle of competitive binding to detect of albumin in human urine. During testing, a urine specimen migrates upward by capillary action. Albumin, if present in the urine specimen at an insufficient concentration, will not saturate the binding sites of antibody coated particles in the test strip. The antibody coated particles will then be captured by immobilized albumin conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the albumin concentration is sufficient because it will saturate all the binding sites of anti- Albumin antibodies. So, a positive urine specimen will not generate a colored line in the test line region because of competition, while a negative urine specimen will generate a line in the test line region.

 

Introduction of Singclean others series

Singclean Alpha-fetoprotein (AFP) assay kit (ELISA) is intended for quantitative determination of the Alpha-fetoprotein (AFP) concentration in human serum. It is based on an enzyme-linked immunosorbent sandwich assay (ELISA). Standards, samples and anti-AFP-HRP conjugate are added to the wells coated with Anti-AFP monoclonal antibody. AFP in the serum binds to antibody coated on the well, and then the anti-AFP-HRP antibody binds to AFP. Unbound proteins are washed off. Upon the addition of the tetramethyl-benzidine (TMB) substrate, the optical density (OD) is proportional to the concentration of AFP in the samples. A standard curve is prepared by plotting option density (OD) to the concentration of the AFP. Then read-off unknown sample values on the standard curve.

 

Singclean bacterial vaginosis quick test kit (sialidase detection)

Singclean bacterial vaginosis quick test kit for qualitatively testing activity of neuraminidase in female’s vaginal fluid, only for auxiliary diagnosis of bacterial vaginosis.

Singclean creatine kinase isoenzyme MB (CK-MB) test kit (fluorescence immunochromatography) is used for the quantitative determination of creatine kinase isoenzyme MB (CK-MB) in human serum, plasma or whole blood samples in vitro.

Singclean procalcitonin (PCT) Test Kit (fluorescence immunochromatography) is used for the quantitative determination of procalcitonin (PCT) in human serum, plasma or whole blood samples in vitro.

Singclean interleukin-6 (IL-6) test kit (fluorescence Immunochromatography) is used for quantitative determination of interleukin-6 (IL-6) in human serum, plasma or whole blood samples in vitro.

The production process of in vitro diagnostics

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