Fisher Healthcare Sure-Vue Kits
Updated Look, Dependable Results
Choose from a wide variety of Fisher Healthcare™ Sure-Vue™ Signature test kits designed to rapidly diagnose a range of conditions with accuracy. Our updated packaging allows you to categorize your kits by color for easy access.
Color Legend
Virology
Adenovirus
Respiratory Syncytial Virus (RSV)
Rotavirus
Rubella
Women's Health
Human Chorionic Gonadotropin (hCG)
Rapid Plasma Reagin (RPR)
Serology
Mononucleosis
Rheumatoid Factor (RF)
Antistreptolysin-O (ASO)
Helicobacter pylori (H. pylori)
Bacterial
Group A Streptococcus
Staphylococcus aureus
Fecal Occult Blood
Fecal Occult Blood Test (FOBT)
Immunochemical Fecal Occult Blood (iFOB)
Parasitology
Cryptosporidium/Giardia
Virology
 |  |  |  |  |  | |
| Sure-VUE Adeno Test Kit | Sure-Vue RSV Test Kit | Sure-Vue Rota Test Kit | Sure-Vue Rubella Latex Test Kit | Sure-Vue SELECT Rubella Latex Test | Sure-Vue Signature Test Influenza A & B Kit | |
|---|---|---|---|---|---|---|
| Assay | Adenovirus | Respiratory syncytial virus (RSV) | Rotavirus | Rubella | Rubella | Influenza types A & B |
| Test Method | Membrane-based immunoassay (cassette) | Membrane-based immunoassay (cassette) | Membrane-based immunoassay (cassette) | Latex slide agglutination | Latex slide agglutination | Manual dipstick |
| Specimen |
| Nasopharyngeal aspirate Nasopharyngeal swab Nasopharyngeal wash | Stool | Serum | Serum | Nasal swab Nasopharyngeal swab |
| Results | Qualitative | Qualitative | Qualitative | NA | Qualitative (immune status) Semi-quantitative (current or recent infection) | NA |
| CLIA Complexity | Non-waived | Waived | Non-waived | Non-waived | Non-waived | Waived |
| Controls | Internal procedural controls only | Procedural controls only | Internal procedural controls only | Controls included:
High-positive Low-positive | Controls included:
High-positive Low-positive | NA |
| Sensitivity | 96.8% | 97% | >98% | 10 IU | 1 to 2 IU (undiluted) 10 IU (diluted) | Influenza A: 90.3% Influenza B: 96.7% |
| Specificity | 94.1% | 98% | >98% | NA | NA | Influenza A: 88.0% Influenza B: 99.2% |
| Time to Result | 15 minutes | 15 minutes | 15 minutes | 5 minutes | 8 minutes | 10 minutes |
| Time to Result | NA | Fisher Healthcare Sure-Vue RSV Test Kit Controls | NA | NA | NA | NA |
| Resources | ||||||
| Buy the Adeno Test Kit | Buy the RSV Test Kit | Buy the Rota Test Kit | Buy the Rubella Latex Test Kit | Buy the SELECT Rubella Latex Test | Buy the Influenza A & B Kit |
Women’s Health
 |  |  |  | |
| Sure-Vue STAT Serum/Urine hCG Test Kit | Sure-Vue Serum/Urine hCG Test Kit | Sure-Vue Urine hCG Test Kit | Sure-Vue RPR Test Kit | |
|---|---|---|---|---|
| Assay | hCG | hCG | hCG | Rapid plasma reagin |
| Test Method | Rapid chromatographic immunoassay (cassette) | Rapid chromatographic immunoassay (cassette) | Rapid chromatographic immunoassay (cassette or dipstick) | Nontreponemal slide flocculation (microparticulate carbon RPR antigen) |
| Specimen | Urine Serum | Urine Serum | Urine | Serum |
| Results | Qualitative | Qualitative | Qualitative |
|
| CLIA Complexity |
|
| Waived | Non-waived |
| Controls | Not included | Not included | Not included | Controls included:
Non-reactive Reactive Weakly-reactive |
| Sensitivity | >99% | >99% | >99% | Same as VDRL |
| Specificity | >99% | >99% | >99% | NA |
| Related Products | Fisher Healthcare Sure-Vue Test Kit Controls | Fisher Healthcare Sure-Vue Test Kit Controls | Fisher Healthcare Sure-Vue Test Kit Controls | NA |
| Resources | Sure-Vue Serum/Urine hCG-STAT Package Insert (PDF, 357KB) Sure-Vue Serum/Urine hCG CLSI (PDF, 417KB) Sure-Vue hCG Combo and Sure-Vue hCG STAT Cassette Test MSDS (PDF, 27KB) | Sure-Vue Urine hCG Strip Package Insert (PDF, 321KB) Sure-Vue hCG Urine Cassette MSDS (PDF, 29KB) Sure-Vue hCG Urine Dipstick MSDS (PDF, 57KB) | ||
| Buy the STAT Serum/Urine hCG Test Kit | Buy the Serum/Urine hCG Test Kit | Buy the Urine hCG Test Kit | Buy the RPR Test Kit |
Serology
 |  |  |  |  |  | |
| Sure-Vue Signature Mono Test Kit | Sure-Vue Color Mono Latex Test Kit | Sure-Vue Mono Latex Test Kit | Sure-Vue RF Rapid Latex Test Kit | Sure-Vue ASO Test Kit | Sure-Vue H. pylori Test | |
|---|---|---|---|---|---|---|
| Assay | Mononucleosis | Mononucleosis | Mononucleosis | Rheumatoid factor | Antistreptolysin-O | Helicobacter pylori |
| Test Method | Color chromatographic Immunoassay (dipstick) | Color-enhanced latex slide agglutination | Latex slide agglutination | Latex slide agglutination | Latex slide agglutination | Rapid chromatographic immunoassay (cassette) |
| Specimen |
|
|
| Serum | Serum |
|
| Results | Qualitative |
|
|
|
| Qualitative |
| CLIA Complexity |
| Non-waived | Non-waived | Non-waived | Non-waived |
|
| Controls | Internal positive and negative controls | Internal positive and negative controls | Internal positive and negative controls | Internal positive and negative controls | Controls included:
| Controls included:
|
| Sensitivity | >99% | 97.9% | 99.4% | 101 IU/mL | 200IU or 100IU | 88% |
| Specificity | 95.7% | 96% | 96% | NA | NA | 88% |
| Time to Result | 5 minutes | 2 minutes | 3 minutes | 2 minutes | 2 minutes | 10 minutes |
| Resources | Sure-Vue Signature Mono Test CLSI (PDF, 58KB) Sure-Vue Signature Mono Test Package Insert (PDF, 1MB) | Sure-Vue H. pylori Test (whole blood only) Package Insert (PDF, 401KB) Sure-Vue H. pylori Test (whole blood/serum/plasma) Package Insert (PDF, 300KB) | ||||
| Buy the Mono Test Kit | Buy the Color Mono Latex Test Kit | Buy the Mono Latex Test Kit | Buy the RF Rapid Latex Test Kit | Buy the ASO Test Kit | Buy the H. pylori Test |
Bacterial
 |  |  |  | |
| Sure-Vue Signature Strep A Test Kit | Sure-Vue Strep A Lateral Flow Test Kit | Sure-Vue SELECT Staph ID Test Kit | Sure-Vue Color Staph ID Latex Test Kit | |
|---|---|---|---|---|
| Assay | Group A Streptococcus | Group A Streptococcus | Staphylococcus aureus | Staphylococcus aureus |
| Berglunds snabbköp | Color chromatographic immunoassay (dipstick) | Rapid chromatographic immunoassay (dipstick) | Latex slide agglutination | Color-enhanced latex slide agglutination |
| Specimen | Throat swab | Throat swab | Colonies from culture plate (incubated overnight) | Colonies from culture plate (incubated overnight) |
| Results | Qualitative | Qualitative | Qualitative | Qualitative |
| CLIA Complexity | Waived | Non-waived | Non-waived | Non-waived |
| Controls | Internal positive and negative controls |
| NA | Controls included:
|
| Sensitivity | 95.7% | 97% | 99% | 99% |
| Specificity | 100% | 95% | 92% | 100% |
| Time to Result | 7 minutes | 6 minutes | Up to 20 seconds | Up to 30 seconds |
| Resources | Sure-Vue Signature Strep A Test Package Insert (Waived) (PDF, 942KB) Sure-Vue Signature Strep A Test Operator Competency Exam (PDF, 72KB) | Sure-Vue Strep A Test Package Insert (Moderately-Complex) (PDF, 313KB) Sure-Vue Strep A Test Package Insert (Waived) (PDF, 318KB) Sure-Vue Rapid Strep A Dipstick Test MSDS (PDF, 57KB) | ||
| Buy the Strep A Test Kit | Buy the Strep A Lateral Flow Test Kit | Buy the SELECT Staph ID Test Kit | Buy the Color Staph ID Latex Test Kit |
Fecal Occult Blood
 |  | |
| Sure-Vue Fecal Occult Blood E-S | Sure-Vue Signature Immunochemical Fecal Occult Blood Test | |
|---|---|---|
| Assay | Fecal occult blood, extra-sensitive | Immunochemical fecal occult blood (iFOB) |
| Test Method | Guaiac | Immunochemical |
| Specimen | Stool | Stool |
| Results | Qualitative | Qualitative |
| CLIA Complexity | Waived | Waived |
| Controls | Internal positive and negative controls |
|
| Sensitivity | 0.3 mg% hemoglobin | >87% (detects levels as low as 50 ng/mL) |
| Specificity | Specificity: 0.5% vs. 1.2% false positives as compared to guaiac; 0.9% vs. 1.2% false positives as compared to guaiac (extra sensitive) | >96% (highly specific for human hemoglobin) |
| Time to Result | 30 seconds | Less than 10 minutes |
| Resources | Sure-Vue Signature iFOBT Controls Set Instructions (PDF, 93KB) | |
| Buy the Fecal Occult Blood E-S | Buy the Fecal Occult Blood Test |
Parasitology
 | |
| Sure-Vue Signature Crypto/GI Test Kit | |
|---|---|
| Assay | Cryptosporidium parvum and Giardia lamblia |
| Test Method | Qualitative immunochromatographic assay |
| Specimen | Stool specimen
In fixative (10% formalin, MIF) In transport media (Cary-Blair, Stuart’s) From culture plate |
| Results | Qualitative |
| CLIA Complexity | Non-waived |
| Controls | External controls sold separately (23-200-278) |
| Sensitivity |
|
| Specificity |
|
| Time to Result | 10 minutes |
| Resources | Sure-Vue Signature Crypto/GI Test Kit IQCP Document (PDF, 236 KB) Sure-Vue Signature Crypto/GI Test Kit Sample Procedure Instruction Sheet (PDF, 79 KB) Sure-Vue Signature Crypto/GI Test Kit Control Set Package Insert (PDF, 95 KB) Sure-Vue Signature Crypto/GI Test Kit Procedure Package Insert (PDF, 194 KB) |
| Buy the Signature Crypto/GI Test Kit |
Available Kits
Adenovirus
Sure-Vue Adeno Test Kit
- Test Method: Membrane-based immunoassay (cassette)
- Specimen: Eye swabs, nasal and nasalpharyngeal secretions, fecal samples, and cell culture supernatant
- Results: Qualitative
- CLIA Complexity: Moderate
- Controls: Internal procedural control only
- Sensitivity: 96.8%
- Specificity: 94.1%
- Time to Result: 15 minutes
Download Product Information
Antistreptolysin-O (ASO)
Download Product Information
Cryptosporidium/Giardia
Sure-Vue Signature Crypto/GI Test Kit
- Test method: Qualitative immunochromatographic assay
- Specimen: Stool or stool specimen in SAF, 10% formalin, MIF, Cary-Blair, C&S, or Stuart’s transport media
- Results: Qualitative
- CLIA Complexity: Moderate
- Controls: External controls sold separately (23200278)
- Sensitivity: Crypto – 97.3%/Giardia – 100%
- Specificity: Crypto – 100%/Giardia – 100%
- Time to Result: 10 minutes
Fecal Occult Blood
Sure-Vue Fecal Occult Blood Test System
- Test Method: Guaiac (paper slide)
- Specimen: Stool
- Results: Qualitative
- CLIA Complexity: Waived
- Controls: Each slide includes Positive and Negative monitors
- Sensitivity: 0.3mg% hemoglobin; 0.2mg% hemoglobin (extra sensitive)
- Specificity: Specificity: 0.5% vs. 1.2% false positives as compared to guaiac; 0.9% vs. 1.2% false positives as compared to guaiac (extra sensitive)
- Time to Result: 30 seconds
Download Product Information
Immunochemical Fecal Occult Blood
Sure-Vue Signature Immunochemical Fecal Occult Blood Test
- Test Method: Immunochemical (iFOB)
- Specimen: Stool
- Results: Qualitative
- CLIA Complexity: Waived
- Controls: Internal quality control included within each test; external QC available for purchase
- Sensitivity: >87% (detects hHB as low as 50ng/mL)
- Specificity: >96% (highly specific for human hemoglobin)
- Time to Result: Less than 10 minutes
Human Chorionic Gonadotropin (hCG)
Sure-Vue Serum/Urine hCG Test Kit
- Test Method: Rapid chromatographic immunoassay (cassette)
- Specimen: Urine or serum
- Results: Qualitative
- CLIA Complexity: Waived (Urine) or Moderate (Serum)
- Controls: Not included
- Sensitivity: >99%
- Specificity: >99%
- Time to Result: 3 minutes (urine); 5 minutes (serum)
Download Product Information
Sure-Vue Urine hCG Test Kit
- Test Method: Rapid chromatographic immunoassay (Cassette or Dipstick)
- Specimen: Urine
- Results: Qualitative
- CLIA Complexity: Waived
- Controls: Not included
- Sensitivity: >99%
- Specificity: >99%
- Time to Result: 3 minutes
Fisher Healthcare Sure-Vue Test Kit Controls
- Specifically for use with Sure-Vue hCG Test Kits
- Controls for Sure-Vue Urine hCG, Sure-Vue Serum/Urine hCG, and Sure-Vue hCG STAT Test Kits
- Includes Negative, Low Positive and High Positive control
Helicobacter pylori (H. pylori)
Sure-Vue H. pylori Test
- Test Method: Rapid chromatographic immunoassay (cassette)
- Specimen: Whole blood, serum or plasma
- Results: Qualitative
- CLIA Complexity: Waived (Whole blood) or Moderate (Serum or Plasma)
- Controls: Includes Positive and Negative
- Sensitivity: 88%
- Specificity: 88%
- Time to Result: 10 minutes
Herpes Simplex Virus Type 2 (HSV-2)
Download Product Information
Mononucleosis
Sure-Vue Signature Mono Test Kit
- Test Method: Color chromatographic Immunoassay (dipstick)
- Specimen: Whole blood, Serum or Plasma
- Results: Qualitative
- CLIA Complexity: Waived (Whole blood) or Moderate (Serum or Plasma)
- Controls: Includes Positive and Negative internal controls
- Sensitivity: >99%
- Specificity: 95.7%
- Time to Result: 5 minutes
Sure-Vue Color Mono Latex Test Kit
- Test Method: Color-enhanced latex slide agglutination
- Specimen: Serum or EDTA Plasma
- Results: Qualitative and Semi-quantitative
- CLIA Complexity: Non-Waived
- Controls: Includes Positive and Negative internal controls
- Sensitivity: 97.9%
- Specificity: 96%
- Time to Result: 2 minutes
Download Product Information
Sure-Vue Mono Latex Test Kit
- Test Method: Latex slide agglutination
- Specimen: Serum or EDTA Plasma
- Results: Qualitative and Semi-quantitative
- CLIA Complexity: Non-Waived
- Controls: Includes Positive and Negative internal controls
- Sensitivity: 99.4%
- Specificity: 96%
- Time to Result: 3 minutes
Download Product Information
Rheumatoid Factor (RF)
Download Product Information
Rotavirus
Download Product Information
Rapid Plasma Reagin (RPR)
Download Product Information
Respiratory Syncytial Virus (RSV)
Download Product Information
Fisher Healthcare Sure-Vue RSV Test Kit Controls
- Specifically for use with Sure-Vue RSV Test Kit
- Detectable Analytes: RSV
- Includes: 1 x 1mL Postive control vial, 1 x 1mL negative control vial
- Quantity: 2 x 1mL
- Product Type: Sure-Vue RSV Control Set
Download Product Information
Rubella
Download Product Information
Sure-Vue Rubella Latex Test Kit
- Test Method: Latex slide agglutination
- Specimen: Serum
- Results: Qualitative and Semi-quantitative
- CLIA Complexity: Moderate
- Controls: Includes Low Positive, High Positive, and Negative controls
- Sensitivity: 1–2 IU (Non-dilution); 10 IU (Dilution)
- Specificity: NA
- Time to Result: 8 minutes
Download Product Information
Staphylococcus aureus
Download Product Information
Sure-Vue Color Staph ID Latex Test Kit
- Test Method: Color-enhanced latex slide agglutination
- Specimen: Colonies from culture plate (incubated overnight)
- Results: Qualitative
- CLIA Complexity: Moderate
- Controls: Includes Positive, Negative and Latex controls
- Sensitivity: 99%
- Specificity: 100%
- Time to Result: Up to 30 seconds
Download Product Information
Group A Streptococcus
Sure-Vue Strep A Lateral Flow Test Kit
- Test Method: Chromatographic immunoassay (dipstick)
- Specimen: Throat swab
- Result: Qualitative
- CLIA Complexity: Waived and Moderate
- Controls: Includes internal procedural controls only
- Sensitivity: 97%
- Specificity: 95%
- Time to Result: 6 minutes
Download Product Information
- Sure-Vue Strep A Test Packing Insert (Moderately-Complex) (PDF, 313KB)
- Sure-Vue Strep A Test Package Insert (Waived) (PDF, 318KB)
- MSDS for Sure-Vue Rapid Strep A Dipstick Test (PDF, 57KB)
- CLSI for Strep A Lateral Flow Test Kit (PDF, 201KB)
- CLSI for Strep A Lateral Flow Test Kit (Waived) (PDF, 200KB)
Fisher Healthcare Sure-Vue Kits Brochure
Find a variety of fast and accurate Fisher Healthcare Sure-Vue diagnostic test kits for everything from women’s health to parasitology.
Sure-Vue HSV-2 Test Instruction Sheet
The Sure-Vue HSV-2 Rapid Test is an immunoassay for the determination of IgG antibodies specific for herpes simplex virus type 2 (HSV-2)
- Sure-Vue HSV-2 Test Instruction Sheet (268.4 KB)
Sure-Vue Mono Test Instruction Sheet
The Sure-Vue Mono Test is a one-step rapid particle agglutination test that aids in the diagnosis of mononucleosis.
- Sure-Vue Mono Test Instruction Sheet (739.2 KB)
Sure-Vue RPR Instruction Sheet
Rapid card test for the detection of reagin antibodies in serum and plasma as a screening test in syphilis serology.
- Sure-Vue RPR Instruction Sheet (1.7 MB)
More
Sure-Vue Rubella Test Instruction Sheet,
Sure-Vue Rubella Test aids in the diagnosis of recent or active rubella infection and determination of immune status.
- Sure-Vue Rubella Test Instruction Sheet, (76.9 KB)
Sure-Vue Select Rubella Test Instruction Sheet
The Sure-Vue Select Rubella Test detects both IgG and IgM anti-rubella virus antibodies in clinical specimens.
Sure-Vue Select Staph ID Instruction Sheet
The Sure-Vue SELECT Staph ID is a rapid test for the detection of both clumping factor and protein A.
Sure-Vue Aso Instruction Sheet
Rapid test for the determination of antistreptolysin-O. Measurement aids in the diagnosis of group A streptococcal infections.
- Sure-Vue Aso Instruction Sheet (93.9 KB)
Sure-Vue Color Mono Test Instruction Sheet
Sure-Vue Color-Mono is a simple color-enhanced slide test for mononucleosis heterophile antibodies.
Sure-Vue Color Staph ID Instruction Sheet
The Sure-Vue Color Staph ID is a rapid, color enhanced latex agglutination test to detect Staphylococcus aureus.
- Sure-Vue Color Staph ID Instruction Sheet (110.9 KB)
Sure-Vue CRP Package Insert
Sure-Vue Rapid test for the qualitative and semiquantitative determination of C-reactive protein in serum by agglutination of latex particles on slide.
- Sure-Vue CRP Package Insert (36.8 KB)
Sure-Vue Urine/Serum hCG Laboratory Procedure
Read the Sure-Vue Urine/Serum hCG Test Laboratory Procedure to review specimen collection, storage, precautions and more.
Sure-Vue Urine hCG Strip Package Insert
The Sure-Vue Urine hCG Strip aids in the early detection of pregnancy by detecting hCG levels.
- Sure-Vue Urine hCG Strip Package Insert (315.8 KB)
Sure-Vue Strep A Test Package Insert (Waived)
The Sure-Vue Strep A Test detects Strep A antigen to aid in the diagnosis of Group A Streptococcal infection.
Sure-Vue Strep A Test Packing Insert (Moderately-Complex)
The Sure-Vue Strep A Test is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.
Sure-Vue Signature Strep A Test Instruction Sheet
The Sure-Vue Signature Strep A Test detects Group A Streptococcal antigen directly from throat swab specimens.
Sure-Vue Serum/Urine hCG-STAT Laboratory Procedure
Read the Sure-Vue Serum/Urine hCG-STAT Laboratory Procedure to review specimen collection, storage, precautions and more.
Sure-Vue Serum/Urine hCG Package Insert
The Sure-Vue Serum/Urine hCG is an immunoassay for the qualitative detection of hCG in serum or urine.
- Sure-Vue Serum/Urine hCG Package Insert (622.6 KB)
Sure-Vue RF Rapid Test
The Sure-Vue RF Rapid Test for the qualitative and semiquantitative determination of rheumatoid factor in serum by agglutination of latex particles on slide.
- Sure-Vue RF Rapid Test (36.9 KB)
Sure-Vue H. pylori Test Package Insert
Sure-Vue H. pylori rapid test is for the qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in whole blood, serum and plasma.
- Sure-Vue H. pylori Test Package Insert (517.3 KB)
Sure-Vue H. pylori Test (whole Blood ONLY) Package Insert
Sure-Vue H. pylori rapid test is for the qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in whole blood.
Sure-Vue H. pylori Test Laboratory Procedure
Read the Sure-Vue H. pylori (Whole Blood, Serum, Plasma) Test Laboratory Procedure to review specimen collection, storage, precautions and more.
Sure-Vue Signature Mono Test Kit - CLSI
Follow along with the sample procedure to see how to use the Fisher Healthcare Sure-Vue Signature Mono Test Kit.
- Sure-Vue Signature Mono Test Kit - CLSI (63.2 KB)
Sure-Vue Serum / Urine hCG-STAT Package Insert
Sure-Vue Serum/Urine hCG-STAT detects human chorionic gonadotropin (hCG) to aid in the early detection of pregnancy.
SureVue h. Pylori Test CLSI
In this test procedure, anti-human IgG is immobilized in the test line region of the device.
- SureVue h. Pylori Test CLSI (247.7 KB)
Sure-Vue Serum Urine hcg Test Kit
The Sure-Vue Serum/Urine hCG is an immunoassay for the detection of hCG to aid in the early detection of pregnancy.
- Sure-Vue Serum Urine hcg Test Kit (237.4 KB)
Sure-Vue NCCLS-OSOM Mono CLSI
The Sure-Vue Signature Mono Test is intended for the detection of antibodies as an aid in the diagnosis of infectious mononucleosis.
- Sure-Vue NCCLS-OSOM Mono CLSI (58 KB)
Sure-Vue Serum/Urine hCG-STAT Laboratory Procedure
This test utilizes a combination of antibodies including mouse monoclonal anti-hCG antibodies and goat polyclonal anti-hCG antibodies to selectively detect elevated levels of hCG.
SureVue Strep A Lateral Flow Test Kit
The Sure-Vue Strep A Test detects Strep A antigen from throat swab specimens to aid in the diagnosis of Streptococcal infection.
- SureVue Strep A Lateral Flow Test Kit (200.9 KB)
SureVue Strep A Lateral Flow Test Kit Waived CLSI
Reference this outline for the SureVue Strep A Lateral Flow Test Kit procedure for the qualitative detection of Strep A antigen from throat swab specimens.
Sure Vue Urine HCG Test Kit - Urine Cassette CLSI
The Sure-Vue Urine hCG detects human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.
Sure-Vue Urine hCG Strip Laboratory Procedure
This test utilizes a combination of antibodies to selectively detect elevated levels of hCG.