Product Details: Size 96 wells/Plate Format Indirect Incubation Time 30 + 30 + 5 + 10 + 1 Sample Type Serum Storage 2-8 C Cat No STGS-R The Scrub Typhus Detectâ?¢ IgG ELISA test for exposure to Orientia tsutsugamushi (OT; formerly Rickettsia) is an ELISA assay system for the detection of IgG antibodies in human serum to OT-derived recombinant antigen. For research use only. Not for use in diagnostic procedures. The complete kit includes one 96 well strippable plate with all necessary reagents and controls.
Product Details: Number of Reactions(Preps)/Ki : 25T Brand : SD Biosensor ICMR Approved : Yes Result Time (Rapid Kits): 10-15 mins CAT No : RK055-25 STANDARD Q COVID-19 Ag is a rapid Immunochromatographic assay for the qualitative detection of specific antigens to SARS-CoV-2 present in human nasopharynx. Qualitatively detects specific antigens to SARS-CoV-2 present in Human Nasopharynx. The test should be used as an aid in early diagnosis of symptomatic cases in healthcare setting having ILI. Validated by ICMR & AIIMS Sensitivity of 84.38 % & Specificity of 100% Sample Type- Human Nasopharyngeal swab (No other sample recommended) Results in 15-30 mins
Product Details: Number of Reactions(Preps)/Kit :96 Brand : Abbott ICMR Approved ; Yes Test Method : (SARS-CoV-2) RT-PCR Cat. No : 09N77-095 The Abbott RealTime SARS-C0V-2 assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories, using real-time (RT) polymerase chain reaction (PCR) technology for the qualitative detection of nucleic acids from the SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection from individuals meeting CDC clinical and/or epidemiological testing criteria
Hayat Rapid Colorimetric & Fluorimetric One Step LAMP SARS-CoV-2 Test Kit We have developed a Multiplex 2-target (N & E genes) direct RT-LAMP assay, without any need of RNA extraction. It has a very high sensitivity ( > 95%) with a fast (30 mins) and easy-to-read result. It works both colorimetric and fluorimetric. Our price is very competitive ranging between 10 USD - 5 USD depending on order volume. The test has CE IVD mark and it is currently under review for NHS & FDA EUA. You can find more details on the attached presentation and IFU.
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : InBios Sample Material : Serum Format : Antigen Detection Incubation Time : 60+30+20+1 Cat No : DNS1-1 The DENV DetectTM NS1 ELISA is for the early detection of Dengue virus (DENV) NS1 antigen in human serum. This test is for the presumptive clinical laboratory diagnosis of Dengue virus infection. This assay is intended for use in patients with clinical symptoms consistent with either dengue fever or dengue hemorrhagic fever. Samples collected from patients within seven (7) days after the onset of clinical symptoms should be evaluated with this assay (day 0 â?? day 7). Negative results obtained with this test do not preclude the diagnosis of dengue and should not be used as the sole basis for treatment or other patient management decision. This assay is not FDA cleared or approved for testing blood or plasma donors. The complete kit includes one 96 well strippable plate with all necessary reagents and controls. FDA Cleared & CE Marked Early NS1 antigen detection (within first 7 days onset of symptoms) Helps differentiate dengue from other flaviviruses that may cross react with dengue antibodies but not with the antigen High Sensitivity & Specificity: 86.6% PPA & 97.8% NPA with prospectively collected positive and negative confirmed clinical specimens Kit can be performed in parallel with InBiosâ?? FDA Cleared dengue IgM ELISA for presumptive diagnosis of acute or convalescent stage dengue virus.
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : serum or plasma Storage : 2 - 8 C Cat No : AE0610 INTENDED USE: The TRUSTwell Syphilis Ab kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of antibodies (IgG, IgM, IgA) against Treponema pallidum (Tp) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with Tp. Any reactive specimen with the TRUSTwell Syphilis Ab ELISA Test must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: The TRUSTwell Syphilis Ab ELISA Test is a solid phase enzyme linked immunosorbent assay based on the principle of the double antigen sandwich technique for the detection of antibodies to Tp in human serum or plasma. The TRUSTwell Syphilis Ab ELISA Test is composed of two key components: 1) Solid microwells pre-coated with recombinant Tp antigens; 2) Liquid conjugates composed of recombinant Tp antigens conjugated with horseradish peroxidase (HRP-Tp conjugates). During the assay, the test specimen and HRP-Tp conjugates are incubated simultaneously with the coated microwells. Antibodies (IgG, IgM, or IgA) to Tp if present in the specimen, reacts to the Tp antigens coated on the microwell surface as well as the HRP-Tp conjugates, forming sandwich complex conjugates. Unbounded conjugates are then removed by washing. The presence of the complexed conjugates is shown by a blue color upon additional incubation with TMB substrate. The reaction is stopped with Stop Solution and absorbances are read using a spectrophotometer at 450 /620-690 nm. Clinical Performance: A total of 1132 patient specimens from susceptible subjects were tested by the TRUSTwell Syphilis Ab ELISA Kit. Relative Sensitivity:100%, Relative Specificity:99.8%, Overall Agreement:99.82%.
Product Details: Number of Reactions(Preps)/Kit : 10T Brand : SD Biosensor ICMR Approved : Yes Result Time (Rapid Kits) : 15 min CAT No : RK013-10 One step, rapid, immunochromatographic test for the detection of IgM/IgG antibodies to four serotypes of dengue virus (DEN-1, DEN-2, DEN-3 and DEN-4) & Dengue virus NS1 antigen in human serum, plasma or whole blood. Kit Contents: Standard Q Dengue Ag Ab Duo cassette x 10 Specimen transfer device 10ml x 10 Butter bottle 4ml x 01 Instructions for use x 1 STANDARD Q Dengue Duo test is an immunochromatographic assay for the detection of NS1 antigen and Dengue virus-specific IgM and IgG antibodies in human serum, plasma and whole blood. By detecting the NS1 antigen, not only the initial infection can be detected, but also Dengue virus-specific IgM and IgG can be detected at the same time. Screening test results can be obtained within 15 minutes with high sensitivity and specificity.
Product Details: Number of Reactions(Preps)/Kit :96 Wells Brand : InBios Sample Material : Serum Formet : Immunocapture Incubation Time : 30+30+30+10 Cat. No : CHKG-C CHIKjj Detect : IgG ELISA Kit The CHIKjj DetectTM IgG ELISA is designed for the qualitative detection of IgG antibodies present in human serum targeting chikungunya virus E2/E1 proteins. This test is for the presumptive clinical laboratory diagnosis of chikungunya virus infection. This assay is intended for use only in patients with clinical symptoms consistent with chikungunya infection. The complete kit includes one 96 well strippable plate with all necessary reagents and controls. Key Features : Developed using a novel technology1 that outperforms traditional antigen preparations, resulting in highly sensitive detection of recent and past CHIKV infection. >90% Sensitivity and Specificity DENV Detect and CHIKjj Detect can be run in parallel for differential diagnosis. CE Marked Ordering : Cat No : CHKG-C Formet : Immunocapture Quantity : 96 wells/Plate Incubation Time : 30 + 30 + 5 + 10 + 1 Sample Type : Serum Storage : 2-8 Shelf Life : 12 months
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : InBios Sample Material : Serum Format : Immunocapture Incubation Time : 30+30+30+10 Cat No : CHKM-R The CHIKjj Detect IgM ELISA is designed for the qualitative detection of IgM antibodies present in human serum targeting Chikungunya virus E2/E1 proteins. This test is not intended to screen blood or blood components. This test is for research use only. Not for use in diagnostic procedures. The complete kit includes one 96 well strippable plate with all necessary reagents and controls. Key Features : InBios chikungunya kits have been developed using a novel technology1 that outperforms traditional antigen preparations, resulting in highly sensitive detection of recent and past CHIKV infection. Excellent results in CDC evaluation of commercially available chikungunya IgM assays. Ordering: Cat No CHKM-R Formet Immunocapture Quantity 96 wells/Plate Incubation Time 30 + 30 + 5 + 10 Sample Type Serum Storage 2-8 Shelf Life 12 months
Product Details: Number of Reactions(Preps)/Kit 10 Brand Abbott Result Time (Rapid Kits) 15 mins Results 15 - 20 min Cat. No 11FK45 Bioline DENGUE DUO (DENGUE NS1 Ag + IgG/IgM)TEST FOR DENGUE INFECTION The Bioline Dengue Duo kit is a rapid, in-vitro immunochromatographic assay designed to detect both dengue virus NS1 antigen and IgG/IgM antibodies against dengue virus in human serum, plasma or whole blood. Bioline Dengue Duo rapid test contains two test devices (left side; Dengue NS1 Ag test, right side; Dengue IgG/IgM test). Benefits: Simultaneous detection of Dengue Ag & Ab Cover all clinical stages from acute phase to convalescence phase of infection Fast test result : 15~20 min Convenient storage condition : 1~30C Specification: Performance - Sensitivity : 92.4% (Dengue NS1 Ag), 94.2% (Dengue IgG/IgM) - Specificity : 98.4%(Dengue NS1 Ag), 96.4% (Dengue IgG/IgM)
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample : Serum / Plasma Storage : 2-8 C Cat No : AE0315 The TRUSTwell CHIK IgM Test is a solid phase enzyme linked immunoabsorbent assay for the qualitative detection of IgM anti- Chikungunya virus in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of acute infection with Chikungunya viruses. Any reactive specimen with the TRUSTwell CHIK IgM Test must be confirmed with alternative testing method(s) and clinical findings. TEST PRINCIPLE: TRUSTwell CHIK IgM Test is a solid phase enzyme linked immunoabsorbent assay based on the principle of the indirect immunoassay technique for the detection of IgM anti- Chikungunya virus in human serum or plasma. The TRUSTwell CHIK IgM Test is composed of two key components: 1) Solid microwells pre-coated with recombinant CHIK antigen(s); 2) Liquid conjugates composed of monoclonal anti-human IgM reagent conjugated with horse reddish peroxidase (HRP-anti-Human IgM conjugates). During the assay, the test specimen is first incubated with the coated microwells. IgM anti- Chikungunya virus, if present in the specimen, binds to the antigen coated on the microwell surface. In the second incubation with the HRP-anti Human IgM conjugates, the IgM antiChikungunya antibody absorbed on the surface of microwell reacts to the conjugates, forming a complexed conjugates. Unbounded conjugates are then removed by washing. The presence of the complexed conjugates is shown by a blue color upon additional incubation with TMB substrate. The reaction is stopped with Stop Solution and absorbances are read using a spectrophotometer at 450 /620-690 nm. Clinical Performance: A total of 336 specimens from susceptible subjects were tested by TRUSTwell CHIK IgM and by a commercial reference ELISA kits. Relative Sensitivity: 91.3 %, (95 % CI: 73.2 % -97.6 %) Relative Specificity: 96.8 %, (95 % CI: 94.2 % -98.3 %) Overall Agreement: 96.4%, (95 % CI: 93.9 % -98.0 %).
Product Details: Brand : CTK BioTech Samples : Serum Storage : 2-8 C Size : 96 Well Cat. No. : E1025 The Total Thyroxine (T4) ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the competitive ELISA technique for quantitative determination of Thyroxine in human serum. The three main kit components are: 1) Solid microwells pre-coated with anti-T4 2) T4 Calibrators 3) Liquid T4 Enzyme Conjugate Mixture comprised of T4 labelled with horseradish peroxidase (T4-HRP) Product Freature: Analytical Sensitivity: 176 aµg/dL at 2-SD Specificity: No cross-reactivity or interference with d-Thyroxine 10 aµg/mL d-Triiodothyronine 100 aµg/mL Iodotyrosine 100 aµg/mL Diiodotyrosine 100 aµg/mL TBG 50 aµg/mL Human Albumin 50 aµg/mL Phenylbutazone 25 aµg/mL Phenytoin 50 aµg/mL ASA 500 aµg/mL Acetaminophen 500 aµg/mL Accuracy: correlation coefficient 0.98 with a reference method Intra Assay Precision: CV a?¤ 5.9% Inter Assay Precision: CV a?¤ 7.6% Product Specification : Anti-T4 Ab Coated Microwells Total T4 Calibrators: C1 (0 ng/mL) C2 (2.0 ng/mL) C3 (5.0 ng/mL) C4 (10.0 ng/mL) C5 (15.0 ng/mL) C6 (25.0 ng/mL) Total T4 Assay Control Total T4 Enzyme Concentrate Enzyme Buffer Wash Buffer Concentrate TMB Substrate Stop Solution Product Insert
Product Details: Brand Abbott Afinion Result Time (Rapid Kits) 15 min Sample Type Blood Country of Origin Made in India Requires only 20 ml of specimen Capillary tubes 20 ml Immediate point of care HbA1c results for efficient monitoring of glycemic control. The Afinion HbA1c assay is a test for quantitative determination of glycated hemoglobin (HbA1c) in human whole blood, used to monitor metabolic control in patients with diabetes. It provides the immediate test results you need for improved diabetic control, better patient outcomes, and enhanced clinic efficiencies. SHORT ASSAY TIME IN 3 MINUTES The CLIA-Waived Afinion HbA1c test gives you reliable, high quality results conveniently available when and where you need them. TIMELY TREATMENT CHANGES Diabetes can be treated and managed by healthful eating, regular physical activity, and medications to lower blood glucose levels. Lowering the HbA1c has been shown to reduce microvascular complications of diabetes and is also associated with long-term reduction in macrovascular disease. LONG SHELF LIFE OF REAGENTS Patient consultations can be carried out with confidence. The HbA1c Test Cartridge contains all reagents necessary for the measurement of glycated hemoglobin. The test has 3 months room temperature storage.
The FactView Typhoid IgG/IgM Rapid Test Kit is a diagnostic assay used for the qualitative detection of IgG and IgM antibodies specific to Salmonella typhi, the bacterium that causes typhoid fever. Here's more information about this type of diagnostic test: Purpose: The test is used for the rapid diagnosis of typhoid fever, a bacterial infection caused by Salmonella typhi. Typhoid fever is characterized by fever, abdominal pain, headache, and other symptoms, and it can lead to serious complications if not treated promptly. Principle: The FactView Typhoid IgG/IgM Rapid Test Kit is an immunochromatographic assay that detects the presence of IgG and IgM antibodies in a patient's blood sample. IgM antibodies are typically produced during the acute phase of infection, while IgG antibodies are produced later during the convalescent phase. Components: The test kit usually includes test cassettes, sample droppers, buffer solutions, and desiccants. The test cassettes contain pre-coated membranes with specific antigens for capturing IgG and IgM antibodies against Salmonella typhi. Procedure: The test procedure involves collecting a small amount of blood from the patient (usually obtained via finger prick) and applying it to the sample well of the test cassette. Buffer solution is then added, allowing the blood sample to migrate along the test strip. Results are typically visible within 15-20 minutes. Interpretation: The appearance of colored lines on the test strip indicates the presence or absence of IgG and IgM antibodies against Salmonella typhi. A visible line in the control region indicates that the test is valid. Additional lines in the test region(s) indicate positive results for IgG and/or IgM antibodies. Sensitivity and Specificity: The FactView Typhoid IgG/IgM Rapid Test Kit demonstrates sensitivity and specificity for detecting typhoid fever. However, like all diagnostic tests, false-positive and false-negative results are possible and should be interpreted in conjunction with clinical findings. Utility: The rapid detection of IgG and IgM antibodies against Salmonella typhi provides valuable information for diagnosing acute or recent typhoid fever infections, determining immune status, and guiding patient management decisions. Limitations: While rapid diagnostic tests are useful for typhoid fever diagnosis, they have limitations compared to more sensitive methods such as blood culture or molecular testing. Factors such as test sensitivity, specificity, and the timing of specimen collection can influence test performance. Overall, the FactView Typhoid IgG/IgM Rapid Test Kit is an important tool for diagnosing typhoid fever, allowing for timely patient management and implementation of control measures. However, results should be interpreted carefully in conjunction with clinical evaluation and other laboratory tests.
Product Description : Allplex 2019 n-COV Assay - Seegene Price of product ( USD price or FOB price) : USD9.0/test FOB Korea Product origin : Republic Of Korea HS code 3822.00.1020 Key Specifications/Special Features : * Target gene: Betacoronavirus (SARS, SARS-related), 2019-nCov * Specimen: Sptim, Nasopharyngeal aspirate, Throat & nasopharyngeal swab, Baronchoalveolar lavage * Analytical sensitivity: all target 100 copies/rxn * Cut-offs: All analytes < 40 sycles * 100%(set.cov) of coverage for genes of RdRP, E and N * RT-PCR condition: 1H 30M (4 steps) * Work flow: Auto exreaction and/or PCR set up --> Amplification & Detection (1.5H) --> Result interpretaion (Whole process TAT
COVID-19 IgG/IgM Rapid Antibody Test Kit with EUA FDA approval. Available immediately! (Whole Blood/Serum/Plasma) is a solid phase immuno chromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirus in human whole blood, serum or plasma. - Fast results as soon as 2-10 minutes - Facilitates patient treatment decisions quickly - Simple, time-saving procedure - Little specimens, only 5L of serum/plasma or 10L of whole blood specimens - All necessary reagents provided & no equipment needed - High sensitivity and specificity - Sensitivity: IgG 97.2%; IgM 87.9% - Specificity: IgG 100%; IgM 100% - Specimen: Whole Blood, Serum, Plasma - Shelf Life: 24 months from the date of manufacture
Unique sealing tube test strip series is the main breaking through the invention of amazing biotech, Which can diagnose all the three stages of the covid19 including Virus, antigen, and antibodies. Here we compare the screening method of different types of testing carried out for Covid-19 including nucleic acid, antigen-based, and antibody-based testing. The comparison is done on the basis of sampling specimen, earliest stage detection, time taken by each, Clinical significance of positive results, Specificity, Sensitivity, and technical difficulty. For nucleic acid testing, the specimen used must be nasopharyngeal swabs, sputum, buffer. For antigen specimen, the specimen must be nasopharyngeal swabs, sputum, buffer, urine. And for antibody-based testing, the specimen used must be plasma and serum. Similarly, the earliest stage detection for nucleic acid testing is after infection, and before symptoms arise. Antigen-based testing is also after infection before symptoms arise and antibody-based testing is One week after symptoms arise. The time taken to carry out the nucleic acid test is 60-180 mins, for antigen test is 10 to 15 minutes and for antibody test is 15 to 180 minutes. Product Detail PRINCIPLE Amazing COVID-19 Antigen Lockseal Tube Test Strip is based on sandwich lateral flow immunochromatographic assay highly sensitively detecting COVID-19 nucleocapsid protein in human nasopharyngeal, nasal secretion, saliva or/and serum specimens, having an invisible T (test) zone and C (control) zone. When the sample is applied into the test tube, the liquid will laterally flow on the surface of the test strip. If there is enough COVID-19 antigen 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 COVID-19 antigen in the sample. Specification V.A: 20/24 kits X 1 pouch/box, 20/24 kits X 5/4 pouches/box V.B: 20/24 kits X 1 pouch/box, 20/24 kits X 5/4 pouches/box V.C: Duplex kits X 10/12 pouches/box, Duplex kits X 48/50 pouches/box V.D: Duplex kits/pouch/box
Product Details: Number of Reactions(Preps)/Kit 30T Brand Abbott Usage/Application Hospital Result Time (Rapid Kits) 15 mins Cat. No 02FK10I30 Bioline HCVHEPATITIS C VIRUS TEST When speed matters, choosing a highly sensitive rapid HCV test with a safe fingerstick procedure can make a difference. In the global effort to eliminating viral hepatitis, fast detection in a wide range of settings and linkage to care are critical for achieving successful outcomes Bioline HCV test is a immunochromatographic rapid test for the qualitative detection of antibodies specific to HCV in human serum, plasma or whole blood. Specification: Specimen : - Serum, Plasma, Whole Blood (10 �¼l) for 02FK10, 02FK10CE, 02FK16, 02FK16CE, 02FK17, 02FK17CE, 02FK11 - Serum or Plasma (10 l) for 02FK12 Sensitivity : - 99.3% (95% CI: 97.9 - 99.8%) for 02FK10CE, 02FK16CE, 02FK17CE - 99.3% (95% CI: 96.1 - 99.9%) for 02FK10, 02FK16, 02FK17 - 100 % (97.6 - 100 %) for 02FK11, 02FK12 Specificity : - 100% (95% CI: 99.7 - 100 %) for 02FK10CE, 02FK16CE, 02FK17CE - 98.1% (95% CI: 94.5 - 99.4%) for 02FK10, 02FK16, 02FK17 - 99.4 % (98.7 - 99.7 %) for 02FK11, 02FK12 Shelf life: 24 months at 1-30C Qualitative immunochromatographic assay Recombinant HCV core, NS3, NS4, NS5 Ag used as capture materials
Product Details: Number of Reactions(Preps)/Kit : 96 Wells Brand : CTK BioTech Sample Material : Plasma/Serum Storage : 2-8 C Cat. No : E0105 INTENDED USE: The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of anti-hepatitis E virus (HEV) IgM in human serum or plasma. It is intended for professional use only and to be used as an aid in the diagnosis of infection with HEV. TEST PRINCIPLE: The RecombiLISA HEV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay based on the principle of the IgM capture technique for the detection of antiHEV IgM in human serum or plasma. The RecombiLISA HEV IgM ELISA is composed of two key components: 1) Solid microwells pre-coated with polyclonal anti-human IgM antibody 2) Liquid conjugate composed of HEV antigen conjugated with horseradish peroxidase (HRP-HEV Conjugate) During the assay, the test specimen is first incubated in the coated microwells. AntiHEV IgM, if present in the specimen, binds to the antibody coated on the microwell surface. Any unbound specimen is then removed by a wash step. During a second incubation with the HRP-HEV Conjugate, the anti-HEV IgM antibody is absorbed on the microwell surface which binds to the HRP-HEV Conjugate, forming a conjugate complex. Unbound conjugate is then removed by washing. After addition of the TMB substrate, the presence of conjugate complex is shown by development of a blue color resulting from a reaction between the enzyme and substrate. The reaction is then quenched by addition of the Stop Solution, and the absorbance value for each microwell is determined using a spectrophotometer at 450/620-690 nm. Clinical Performance: A total of 400 specimens from susceptible subjects were tested by the RecombiLISA HEV IgM ELISA and by a Chinese State Drug Administration (SFDA) licensed reference EIA. Clinical Performance: Relative Sensitivity: 100%, Relative Specificity: 100%, Overall Agreement: 100%.
Product Details: Number of Reactions(Preps)/Kit ; 96 Wells Brand : InBios Format : Immunocapture Specimen : Serum Cat No : ZKM2-1 The ZIKV Detect 2.0 IgM Capture ELISA is intended for the qualitative detection of Zika virus IgM antibodies in human sera for the presumptive clinical laboratory diagnosis of Zika virus infection. The assay is intended for use only in patients with clinical signs and symptoms consistent with Zika virus infection, and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiological criteria for which Zika virus testing may be indicated). Assay results are for the presumptive detection of IgM antibodies to Zika virus (ZIKV). Positive results must be confirmed by following the latest CDC guidelines for the diagnosis of Zika virus infection. Results of this test are intended to be used in conjunction with clinical observations, patient history, epidemiological information, and other laboratory evidence to make patient management decisions. Zika IgM levels are variable over the course of the infection and may be detectable near day four post onset of symptoms and persist up to approximately 12 weeks following initial infection. Negative results may be seen in specimens collected before day four post onset of symptoms or after the window of detectable IgM closes, and therefore do not preclude the possibility of Zika virus infection, past or present. 1st Commercial serology kit to receive FDA Marketing Authorization CE Marked Differentiates Zika IgM positive patients from those infected with other flaviviruses such as West Nile or Dengue Sensitivity: >90% Specificity: >96% Results in 4 hours Tests up to 28 unknown specimens.