Fisher Healthcare Sure-Vue Kits

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Available 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

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Virology

Adenovirus
Respiratory Syncytial Virus (RSV)
Rotavirus
Rubella

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Women's Health

Human Chorionic Gonadotropin (hCG)
Rapid Plasma Reagin (RPR)

surevue-serology-blue

Serology

Mononucleosis
Rheumatoid Factor (RF)
Antistreptolysin-O (ASO)
Helicobacter pylori (H. pylori)

surevue-bacterial-light-green

Bacterial

Group A Streptococcus
Staphylococcus aureus

surevue-fecal-red

Fecal Occult Blood

Fecal Occult Blood Test (FOBT)
Immunochemical Fecal Occult Blood (iFOB)

surevue-parasitology-green

Parasitology

Cryptosporidium/Giardia

Virology

 
 Sure-VUE Adeno Test KitSure-Vue RSV Test KitSure-Vue Rota Test KitSure-Vue Rubella Latex Test KitSure-Vue SELECT Rubella Latex TestSure-Vue Signature Test Influenza A & B Kit
AssayAdenovirusRespiratory syncytial virus (RSV)RotavirusRubellaRubellaInfluenza types A & B
Test MethodMembrane-based immunoassay (cassette)Membrane-based immunoassay (cassette)Membrane-based immunoassay (cassette)Latex slide agglutinationLatex slide agglutinationManual dipstick
Specimen
  • Eye swabs
  • Nasal and nasopharyngeal secretions
  • Fecal samples
  • Cell culture supernatant

Nasopharyngeal aspirate

Nasopharyngeal swab

Nasopharyngeal wash

StoolSerumSerum

Nasal swab

Nasopharyngeal swab

ResultsQualitativeQualitativeQualitativeNA

Qualitative (immune status)

Semi-quantitative (current or recent infection)

NA
CLIA ComplexityNon-waivedWaivedNon-waivedNon-waivedNon-waivedWaived
ControlsInternal procedural controls onlyProcedural controls onlyInternal procedural controls onlyControls included:

High-positive

Low-positive

Controls included:

High-positive

Low-positive

NA
Sensitivity96.8%97%>98%10 IU

1 to 2 IU (undiluted)

10 IU (diluted)

Influenza A: 90.3%

Influenza B: 96.7%

Specificity94.1%98%>98%NANA

Influenza A: 88.0%

Influenza B: 99.2%

Time to Result15 minutes15 minutes15 minutes5 minutes8 minutes10 minutes
Time to ResultNAFisher Healthcare Sure-Vue RSV Test Kit ControlsNANANANA
Resources

Sure-Vue Adeno Test Instruction Sheet (PDF, 163KB)

Sure-Vue Adenovirus Controls Package Insert (PDF, 95KB)

Sure-Vue RSV Test Instruction Sheet (PDF, 154KB)

Sure-Vue Rota Test Instruction Sheet (PDF, 167KB)

Sure-Vue Rotavirus Controls Package Insert (PDF, 81KB)

Sure-Vue Select Rubella Instruction Sheet (PDF, 121KB)

Sure-Vue Select Rubella Instruction Sheet (PDF, 121KB)

Buy the Adeno Test KitBuy the RSV Test KitBuy the Rota Test KitBuy the Rubella Latex Test Kit Buy the SELECT Rubella Latex TestBuy the Influenza A & B Kit

Women’s Health

 
 Sure-Vue STAT Serum/Urine hCG Test KitSure-Vue Serum/Urine hCG Test KitSure-Vue Urine hCG Test KitSure-Vue RPR Test Kit
AssayhCGhCGhCGRapid plasma reagin
Test MethodRapid 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

UrineSerum
ResultsQualitativeQualitativeQualitative
  • Qualitative
  • Semi-qualitative
CLIA Complexity
  • Waived (urine)
  • Non-waived (serum)
  • Waived (urine)
  • Non-waived (serum)
WaivedNon-waived
ControlsNot includedNot includedNot includedControls included:

Non-reactive

Reactive

Weakly-reactive

Sensitivity>99%>99%>99%Same as VDRL
Specificity>99%>99%>99%NA
Related ProductsFisher Healthcare Sure-Vue Test Kit ControlsFisher Healthcare Sure-Vue Test Kit ControlsFisher Healthcare Sure-Vue Test Kit ControlsNA
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 Serum/Urine hCG Package Insert (PDF, 371KB)

Sure-Vue Urine hCG Strip Package Insert (PDF, 321KB)

Sure-Vue hCG Urine Cassette Package Insert (PDF, 27KB)

Sure-Vue hCG Urine Cassette MSDS (PDF, 29KB)

Sure-Vue hCG Urine Dipstick MSDS (PDF, 57KB)

CLSI - Dipstick Instruction Sheet (PDF, 49KB)

CLSI - Urine Cassette Instruction Sheet (PDF, 236KB)

Sure-Vue RPR Package Insert (PDF, 1.7MB)

Buy the STAT Serum/Urine hCG Test KitBuy the Serum/Urine hCG Test KitBuy the Urine hCG Test KitBuy the RPR Test Kit

Serology

 
 Sure-Vue Signature Mono Test KitSure-Vue Color Mono Latex Test KitSure-Vue Mono Latex Test KitSure-Vue RF Rapid Latex Test KitSure-Vue ASO Test KitSure-Vue H. pylori Test
AssayMononucleosisMononucleosisMononucleosisRheumatoid factorAntistreptolysin-OHelicobacter pylori
Test MethodColor chromatographic Immunoassay (dipstick)Color-enhanced latex slide agglutinationLatex slide agglutinationLatex slide agglutinationLatex slide agglutinationRapid chromatographic immunoassay (cassette)
Specimen
  • Whole blood
  • Serum
  • Plasma
  • Serum
  • Plasma (EDTA)
  • Serum
  • Plasma (EDTA)
SerumSerum
  • Whole blood
  • Serum
  • Plasma
ResultsQualitative
  • Qualitative
  • Semi-quantitative
  • Qualitative
  • Semi-quantitative
  • Qualitative
  • Semi-quantitative
  • Qualitative
  • Semi-qualitative
Qualitative
CLIA Complexity
  • Waived (whole blood)
  • Non-waived (serum or plasma)
Non-waivedNon-waivedNon-waivedNon-waived
  • Waived (whole blood)
  • Non-waived (serum or plasma)
ControlsInternal positive and negative controlsInternal positive and negative controlsInternal positive and negative controlsInternal positive and negative controlsControls included:
  • Positive
  • Negative
Controls included:
  • Positive
  • Negative
Sensitivity>99%97.9%99.4%101 IU/mL200IU or 100IU88%
Specificity95.7%96%96%NANA88%
Time to Result5 minutes2 minutes3 minutes2 minutes2 minutes10 minutes
Resources

Sure-Vue Signature Mono Test CLSI (PDF, 58KB)

Sure-Vue Signature Mono Test Package Insert (PDF, 1MB)

Sure-Vue Signature Mono Training Quiz (PDF, 61KB)

Sure-Vue Signature Training Certificate (PDF, 52KB)

Sure-Vue Color Mono Package Insert (PDF, 56KB)

Sure-Vue Color Mono Package Insert (PDF, 739KB)

Sure-Vue RF Rapid Test Package (PDF, 37KB)

Sure-Vue ASO Package Insert (PDF, 105KB)

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)

Sure-Vue H. pylori Test Device MSDS (PDF, 76KB)

Sure-Vue H. pylori Test Laboratory Procedure (PDF, 76KB)

Buy the Mono Test Kit Buy the Color Mono Latex Test KitBuy 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 KitSure-Vue Strep A Lateral Flow Test KitSure-Vue SELECT Staph ID Test KitSure-Vue Color Staph ID Latex Test Kit
AssayGroup A StreptococcusGroup A StreptococcusStaphylococcus aureusStaphylococcus aureus
Berglunds snabbköpColor chromatographic immunoassay (dipstick)Rapid chromatographic immunoassay (dipstick)Latex slide agglutinationColor-enhanced latex slide agglutination
SpecimenThroat swabThroat swabColonies from culture plate (incubated overnight)Colonies from culture plate (incubated overnight)
ResultsQualitativeQualitativeQualitativeQualitative
CLIA ComplexityWaivedNon-waivedNon-waivedNon-waived
ControlsInternal positive and negative controls
  • Internal procedural controls
  • External controls sold separately
NAControls included:
  • Positive
  • Negative
  • Test Latex
Sensitivity95.7%97%99%99%
Specificity100%95%92%100%
Time to Result7 minutes6 minutesUp to 20 secondsUp 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 Signature Training Certificate (PDF, 52KB)

Sure-Vue Strep A Package Insert (PDF, 412KB)

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)

CLSI for Strep A Lateral Flow Test Kit (PDF, 201KB)

Strep A Lateral Flow Test Kit (Waived) (PDF, 200KB)

Sure-Vue SELECT Staph ID Instruction Sheet (PDF, 91KB)

Sure-Vue Color Staph ID Package Insert (PDF, 111KB)

Buy the Strep A Test Kit Buy the Strep A Lateral Flow Test Kit Buy the SELECT Staph ID Test KitBuy the Color Staph ID Latex Test Kit

Fecal Occult Blood

 
 Sure-Vue Fecal Occult Blood E-SSure-Vue Signature Immunochemical Fecal Occult Blood Test
AssayFecal occult blood, extra-sensitiveImmunochemical fecal occult blood (iFOB)
Test MethodGuaiacImmunochemical
SpecimenStoolStool
ResultsQualitativeQualitative
CLIA ComplexityWaivedWaived
ControlsInternal positive and negative controls
  • Internal positive and negative controls
  • External controls sold separately
Sensitivity0.3 mg% hemoglobin>87% (detects levels as low as 50 ng/mL)
SpecificitySpecificity: 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 Result30 secondsLess than 10 minutes
Resources

Sure-Vue Signature iFOBT Controls Set Instructions (PDF, 93KB)

Sure-Vue Signature iFOBT Instruction Sheet (PDF, 159KB)

Buy the Fecal Occult Blood E-SBuy the Fecal Occult Blood Test

Parasitology

 
 Sure-Vue Signature Crypto/GI Test Kit
AssayCryptosporidium parvum and Giardia lamblia
Test MethodQualitative immunochromatographic assay
SpecimenStool specimen

In fixative (10% formalin, MIF)

In transport media (Cary-Blair, Stuart’s)

From culture plate

ResultsQualitative
CLIA ComplexityNon-waived
ControlsExternal controls sold separately (23-200-278)
Sensitivity
  • Crypto – 97.3%
  • Giardia – 100%
Specificity
  • Crypto – 100%
  • Giardia – 100%
Time to Result10 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)

Fisher Healthcare Sure-Vue Kits Brochure

Buy the Signature Crypto/GI Test Kit
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Available Kits


Adenovirus

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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

Antistreptolysin-O (ASO)

ASO-test-kit-19-2487

Sure-Vue ASO Test Kit

  • Test Method: Latex slide agglutination
  • Specimen: Serum
  • Results: Qualitative or Semi-quantitative
  • CLIA Complexity: Non-Waived
  • Controls: Includes Positive and Negative controls
  • Sensitivity: 200IU or 100IU
  • Specificity: NA
  • Time to Result: 2 minutes

Cryptosporidium/Giardia

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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

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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

Immunochemical Fecal Occult Blood

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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)

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Sure-Vue STAT 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)
new-serum-urine-hcg-test-kit-19-2487

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)
urine-hcg-test-kit-19-2487

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
serum-hcg-controls-19-2487

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)

fisher-healthcare-surevue-h-pylori-kit

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

Mononucleosis

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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
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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
latex-mono-test-kit-19-2487

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

Rheumatoid Factor (RF)

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Sure-Vue RF Rapid Latex Test Kit

  • Test Method: Latex slide agglutination
  • Specimen: Serum
  • Results: Qualitative and Semi-quantitative
  • CLIA Complexity: Non-Waived or Moderate
  • Controls: Includes Positive and Negative controls
  • Sensitivity: 10IU/mL
  • Specificity: NA
  • Time to Result: 2 minutes

Rotavirus

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Sure-Vue Rota Test Kit

  • Test Method: Membrane-based immunoassay (cassette)
  • Specimen: Stool
  • Results: Qualitative
  • CLIA Complexity: Non-Waived
  • Controls: Includes internal procedural controls only
  • Sensitivity: >98%
  • Specificity: >98%
  • Time to Result: 15 minutes

Rapid Plasma Reagin (RPR)

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Sure-Vue RPR Test Kit

  • Test Method: Nontreponemal Slide flocculation (carbon)
  • Specimen: Serum
  • Results: Qualitative and Semi-quantitative
  • CLIA Complexity: Moderate
  • Controls: Includes Non-Reactive, Reactive, and Weakly-Reactive controls
  • Sensitivity: Same as VDRL
  • Specificity: NA
  • Time to Result: 8 minutes

Respiratory Syncytial Virus (RSV)

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Sure-Vue RSV Test Kit

  • Test Method: Membrane-based immunoassay (cassette)
  • Specimen: Nasopharyngeal aspirate, swab or wash
  • Results: Qualitative
  • CLIA Complexity: Waived and Moderate
  • Controls: Procedural controls only
  • Sensitivity: 97%
  • Specificity: 98%
  • Time to Result: 15 minutes
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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

Rubella

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Sure-Vue SELECT Rubella Latex Test

  • Test Method: Latex slide agglutination
  • Specimen: Serum
  • Results: 5 minutes
  • CLIA Complexity: Moderate
  • Controls: High positive, low positive, and negative controls included
  • Sensitivity: 10 IU
  • Specificity: NA
  • Time to Result: 5 minutes
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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

Staphylococcus aureus

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Sure-Vue SELECT Staph ID Test Kit

  • Test Method: Latex slide agglutination
  • Specimen: Colonies from culture plate (incubated overnight)
  • Results: Qualitative
  • CLIA Complexity: Moderate
  • Controls: Not included
  • Sensitivity: 99%
  • Specificity: 92%
  • Time to Result: Up to 20 seconds
color-latex-staph-id-test-kit-19-2487

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

Group A Streptococcus

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Sure-Vue Signature Strep A Test Kit

  • Test Method: Color chromatographic immunoassay(dipstick)
  • Specimen: Throat swab
  • Result: Qualitative
  • CLIA Complexity: Waived
  • Controls: Includes Positive and Negative controls
  • Sensitivity: 95.7%
  • Specificity: 100%
  • Time to Result: 7 minutes
lateral-flow-strep-a-test-kit-19-2487

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
Resources

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